[Federal Register: August 21, 2009 (Volume 74, Number 161)]
[Proposed Rules]
[Page 42203-42217]
[DOCID:fr21au09-11]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. FDA-2008-N-0393]
RIN 0910-AF86

Medical Device Reporting: Electronic Submission Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its postmarket medical device reporting regulation to require that
manufacturers, importers, and user facilities submit mandatory reports
of individual medical device adverse events, also known as medical
device reports (MDRs) to the agency in an electronic format that FDA
can process, review, and archive. Mandatory electronic reporting would
improve the agency's process for collecting and analyzing postmarket
medical device adverse event information. The proposed regulatory
changes would provide the agency with a more efficient data entry
process that would allow for timely access to medical device adverse
event information and identification of emerging public health issues.
Elsewhere in this issue of the Federal Register, FDA is also announcing
a draft guidance document that provides recommendations on how to
prepare and submit electronic MDRs to FDA in a manner that satisfies
the requirements

of this proposed regulation. The proposal also includes modifications
to the regulations specifying the content of required MDRs to better
track information already solicited on the FDA Form 3500A.

DATES: November 19, 2009. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 (the PRA) by September
21, 2009, (see the ``Paperwork Reduction Act of 1995'' section of this
document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0393 and/or RIN number 0910-AF86, by any of the following methods,
except that comments on information collection issues under the
Paperwork Reduction Act of 1995 must be submitted to the Office of
Regulatory Affairs, Office of Management and Budget (OMB) (see the
``Paperwork Reduction Act of 1995'' section of this document).
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
    Information Collection Provisions: The information collection
provisions of this proposed rule have been submitted to OMB for review.
Interested persons are requested to fax or e-mail comments regarding
the information collection provisions by September 21, 2009, to the
Office of Information and Regulatory Affairs, OMB. To ensure that
comments on information collection are received, OMB recommends that
written comments be faxed to<PHONE_NUMBER> or e-mailed to OIRA_
<EMAIL_ADDRESS>Please reference this proposed rule and OMB
Control Number 0910-0437 and mark your comments to the Attention of the
FDA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Howard Press, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Building 66, rm. 3320, Silver Spring, MD 20993-0002, 301-796-
6087.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
    A. What Are the Medical Device Reporting Requirements?
    1. What Are the Current Reporting Requirements for Manufacturers
and What Is Their Status?
    2. What Are the Current Reporting Requirements for Importers?
    3. What Are the Current Reporting Requirements for User Facilities?
    B. What Format Is Currently Used for Submitting Postmarket Medical
Device Reports?
    C. Why Is FDA Proposing to Require Electronic Submissions of MDRs?
    1. What Are the Options for Electronic Reporting?
    2. What Is the FDA Electronic Submission Gateway (ESG)?
    3. How Do I Know FDA Received My Electronic Submission and It Was
Successfully Processed?
II. Description of the Proposed Rule
    A. How Would the Rule Address Submission of Reports in Electronic
Format?
    1. How Would the Reporting Requirements for Manufacturers Change
With Respect to Electronic Format?
    2. How Would the Reporting Requirements for Importers Change With
Respect to Electronic Format?
    3. How Would the Reporting Requirements for User Facilities Change
With Respect to Electronic Format, and How Would Annual Report
Requirements be Affected?
    4. How Would the Requirement to Submit Reports in Electronic Format
Affect Recordkeeping Requirements?
    B. How Would I Submit MDRs in Electronic Format?
    C. How Can a Medical Device Manufacturer, Importer, or User
Facility Obtain a Variance Regarding the Requirement to Submit a Report
in Electronic Format?
    D. What Other Changes Are Being Proposed?
    E. When Would the Rule Become Effective?
III. What Is the Legal Authority for This Rule
IV. Is There an Environmental Impact?
V. Analysis of Impacts
    A. Benefits
    B. Costs
    1. One-Time Costs
    a. Rewriting SOPs and training personnel
    b. Setting up systems for submission
    c. Electronic certificates
    2. Annual costs
    a. Maintaining electronic certificates
    b. High-speed Internet access
    C. Summary of Benefits and Costs
    D. Alternatives Considered
    E. Regulatory Flexibility Analysis
VI. Paperwork Reduction Act of 1995
    A. Reporting Requirements
    B. Recordkeeping Requirements
    C. Total Annual Cost Burden
VII. Federalism
VIII. Request for Comments
IX. References

I. Introduction

    In this proposal, we provide background information on the current
status of FDA's medical device reporting requirements, explain the
revisions we are proposing here, and describe our approach to
electronic medical device reporting.
    For over 20 years, FDA has received postmarket MDRs in a paper
format. This proposed rule to require the electronic submission to FDA
of most MDRs is an important step towards improving the agency's
systems for collecting and analyzing postmarket MDRs. The proposed rule
includes reports of deaths, serious injuries, and malfunctions that
must be reported to FDA in initial 5-day, 10-day, or 30-day individual
MDRs or in supplemental reports. We believe this proposed rule would
have the following benefits:
     Reduce industry's time and costs associated with
transcribing data from internal data management systems to paper and
mailing the paper reports to the agency,

     Eliminate the agency's transcription errors, time, and
costs associated with receiving paper reports and transcribing data to
electronic format for review and analysis,
     Expedite the agency's access to safety information in a
format that would support more efficient and comprehensive data
analysis and reviews, and
     Enhance the agency's ability to rapidly communicate
information about suspected problems to the medical device industry,
health care providers, consumers, and other government agencies.
    In addition, this proposed rule is consistent with the Government
Paperwork Elimination Act (Public Law 105-277) requirement that Federal
agencies allow individuals or entities to submit information or
transact business with the agency electronically.

A. What Are the Medical Device Reporting Requirements?

    The requirements of current medical device reporting regulations
are summarized in sections I.A.1 to I.A.3 of this document. In
addition, we address changes to these regulations to be effected
outside of this proposed rule.
    Current MDR regulations (part 803 (21 CFR part 803)) require
manufacturers and importers of marketed medical devices, and user
facilities, to submit postmarket reports of individual medical device
adverse events to FDA on the FDA Form 3500A.
1. What Are the Current Reporting Requirements for Manufacturers and
What Is Their Status?
    The current MDR regulation requires that manufacturers of medical
devices submit a postmarket MDR of an individual adverse event no later
than 30 calendar days after becoming aware of information that a device
the manufacturer markets may have caused or contributed to a death,
serious injury, or malfunction (Sec.  803.50). This report must be
submitted on the FDA Form 3500A, (Sec.  803.20), and contain
information described in Sec.  803.52.
    In addition, the regulation requires manufacturers to provide
supplemental information about such events, on an FDA Form 3500A,
within 30 calendar days of obtaining information should such
information become available after the initial MDR was filed with FDA
(Sec.  803.56). In instances where the medical device adverse event
resulted in remedial action to prevent an unreasonable risk of
substantial harm to the public health, or at the discretion of the
agency, the regulation requires the manufacturer to submit an MDR to
the agency no later than 5 working days after becoming aware of the
information (Sec.  803.53).
    Title II, section 227, of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Public Law 110-85), amended section 519
of the Federal Food, Drug, and Cosmetic Act (the act) to require that
FDA establish criteria for manufacturer reports of malfunctions for
most class I and certain class II devices that include requiring those
reports to be in summary form and made on a quarterly basis. The types
of events required to be reported are unchanged. FDA intends to address
changes necessitated by this statutory change separately from this
proposed rule, and will address requirements for submission of those
new summary malfunction reports at that time. However, some individual
malfunction reports will continue to be required even after the FDAAA-
related changes, and as explained below, the rule proposed here does
address submission of individual malfunction reports to the agency.
2. What Are the Current Reporting Requirements for Importers?
    The MDR regulation requires that importers of medical devices
submit a postmarket MDR to the agency and the manufacturer no later
than 30 calendar days after becoming aware of information that
reasonably suggests that one of the importer's marketed devices may
have caused or contributed to a death or serious injury (Sec.
803.40(a)). Importers must submit reports to the manufacturer no later
than 30 calendar days after becoming aware of information that
reasonably suggests that one of the importer's marketed devices has
malfunctioned and that this device or a similar device marketed by the
importer would be likely to cause or contribute to a death or serious
injury if the malfunction were to recur (Sec.  803.40(b)). These
reports must be submitted on the FDA Form 3500A (see Sec.  803.20) and
contain the information specified in Sec.  803.42.
3. What Are the Current Reporting Requirements for User Facilities?
    The MDR regulation requires that user facilities submit a
postmarket MDR of death to the agency and an MDR of death or serious
injury to the device manufacturer within 10 working days of becoming
aware of information that reasonably suggests that a device has or may
have caused or contributed to the death or a serious injury of a
patient of the facility. (Sec.  803.30(a)). The regulation requires
that user facilities submit postmarket reports of serious injury to the
agency within 10 working days if the manufacturer of the device is
unknown or cannot be identified (Sec.  803.30(a)(2)). These reports
must be submitted on the FDA Form 3500A (see Sec.  803.20(a)), and
include the information described in Sec.  803.32.
    In addition, user facilities are required to submit to the agency
an annual summary of the reports they sent to manufacturers and the
FDA, using FDA Form 3419 (Sec.  803.33). The proposal to require
submission of reports to FDA in an electronic format does not apply to
user facility annual reports made under Sec.  803.33, although other
changes to Sec.  803.33 are proposed as explained in section I.B of
this document.

B. What Format Is Currently Used for Submitting Postmarket Medical
Device Reports?

    Current regulations at Sec.  803.20(a) require that user
facilities, importers, and manufacturers use the FDA Form 3500A to
submit mandatory reports about FDA-regulated devices. This requirement
took effect July 31, 1996 (see 60 FR 63578, December 11, 1995; 61 FR
16043, April 11, 1996).
    Certain blocks of the FDA Form 3500A are required only for user
facilities, while others are required only for manufacturers (see Sec.
803.20(a)(2)).
    Subsequent to its initial adoption, FDA revised the Form 3500A and
its instructions, adding elements including the premarket approval
application (PMA) or 510(k) number for the device, and two questions
regarding reprocessed single-use devices. The agency was required to
revise the form to include the questions regarding reprocessed single-
use devices under section 303 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250). The revised FDA Form
3500A is approved under the PRA, under OMB control number 0910-0291.
    FDA Form 3500A has been routinely completed on paper and
transmitted to FDA by mail, requiring FDA to manually input information
from those reports into its internal electronic systems before it can
be reviewed and analyzed. This process is extremely time consuming,
costly, and susceptible to data entry errors. Because FDA regulations
at Sec.  803.14 provide for the possibility of voluntary electronic
submission of MDRs, with agency permission, several regulations in part
803 refer to submission of reports using the FDA Form 3500A ``or an
electronic equivalent approved under section 803.14.'' (See, e.g.,
Sec. Sec.  803.30, 803.40, and 803.53.) However, reporters have not
made use of section 803.14 to

pursue voluntary electronic submission of MDRs, and FDA's legacy
systems were not in general designed to accept submission of MDRs in
electronic format.

C. Why Is FDA Proposing to Require Electronic Submission of MDRs?

    When a medical device has been cleared for marketing and enters the
market, the product is introduced to a larger patient population in
settings different from clinical trials. New information generated
during the postmarketing period offers further insight into the
benefits or risks of the product, and evaluation of this information is
important for all products to ensure their safe use. Historically, FDA
has received almost all postmarket MDRs on paper through the mail. When
data elements are provided to FDA on only paper, the information must
be entered by hand into an electronic format for review and analysis.
This process is extremely time consuming, costly, and susceptible to
data entry errors.
    The electronic submission of medical device reports would lead to
more efficient reviews, enhancing our ability to rapidly disseminate
significant information to the medical device industry, health care
providers, and consumers, in support of FDA's public health mission.
    Electronic submissions would also improve the speed and efficiency
of both industry and agency operations. Electronic reporting can
benefit industry by reducing the costs associated with collating,
copying, storing, retrieving, and mailing paper medical device reports
to the agency on FDA Form 3500A. In addition, the agency benefits from
the elimination of manual data entry processes and reductions in
physical storage for paper copies of the FDA Form 3500A. Based on low
rates of participation in prior pilot voluntary electronic MDR
submission programs, FDA believes that without a regulation requiring
electronic submission of MDRs a large number of medical device firms
and user facilities would resist changing their procedures for a long
period of time. This delay would hinder our achieving the benefits of
standardized formats and quicker access to MDR data.
1. What Are the Options for Electronic Reporting?
    FDA's Center for Devices and Radiological Health (CDRH) has
established its MDR databases currently to support two options for
electronic submission of MDRs: One designed for low volume reporting
and one designed for high volume reporting. Both options make use of
the FDA Electronic Submission Gateway (FDA ESG), a secure electronic
portal described further in this document, for transmission of reports
to FDA. In accordance with 21 CFR 11.2(b), CDRH is now accepting on a
voluntary basis, in lieu of paper, MDRs prepared and transmitted in
accordance with these options. More information on electronic
submission of MDRs is available at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/PostmarketRequirements/
ReportingAdverseEvents/ucm127932.htm.
    For low-volume medical device reporting (few or infrequent MDRs),
the current approach developed by the agency uses the CDRH eSubmitter
(CeSub) software. The CeSub software allows for the submission of one
MDR at a time. The software provides the following tools:
     Save address and contact information,
     Search for a Product Code,
     Search to locate a patient or Device Problem Code,
     Search to find manufacturer evaluation codes (method,
result, and conclusion),
     Attach documents when additional information needs to be
provided,
     Produce a ``missing data report'' to help ensure that all
required information is supplied before submission to FDA.
    Once the MDR is completed, the file is ``packaged for submission.''
The package generates an electronic version of the FDA Form 3500A,
which can be submitted to FDA using the FDA ESG. The final CeSub-
generated report can also be saved or printed, for recordkeeping or to
provide reports to manufacturers or other entities outside of FDA. The
CeSub software and instructions for installation are free and available
at: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm. We may
sometimes update or change our methodology, approach or software to
improve the low-volume reporting experience.
    Reporters with large volumes of MDRs may prefer the second option,
called the Health Level 7 Individual Case Safety Report (HL7 ICSR). The
HL7 ICSR was developed in conjunction with the HL7 standards
organization to support the exchange of electronic data. This option
allows for the extraction directly from the reporter's database of
information to populate an MDR, production of the appropriate data
output, and transmission of the MDRs to the FDA ESG. The HL7 ICSR
supports the batch submission of more than one individual MDR at a
time. Reporters developing applications using the HL7 ICSR standard may
also build functions for saving or printing those reports.
    The draft guidance document announced elsewhere in this Federal
Register provides information on both options for electronic submission
of MDRs.
2. What Is the FDA Electronic Submission Gateway (ESG)?
    The FDA ESG is the entry point for all electronic submissions to
the agency. The FDA ESG is available 24 hours a day, 7 days a week.
Information on the FDA ESG is available at http://www.fda.gov/
ForIndustry/ElectronicSubmissionsGateway/default.htm. To use the FDA
ESG, reporters need to have a digital certificate. A digital
certificate is an attachment to an electronic message that allows the
recipient to authenticate the identity of the sender via third party
verification from an independent certificate authority. Digital
certificates are used to identify encryption and decryption codes
between message senders and recipients. Information on digital
certificates can be found at http://www.fda.gov/ForIndustry/
ElectronicSubmissionsGateway/ucm113223.htm.
3. How Do I Know FDA Received My Electronic Submission and It Was
Successfully Processed?
    FDA's electronic submission processing system sends the submitter
three different acknowledgments (messages) for each submission.
Acknowledgment 1 comes from the ESG and indicates your submission was
received. Acknowledgment 2 is sent by the ESG and indicates the
submission reached CDRH. CDRH sends Acknowledgment 3 and notifies you
whether your submission was successfully loaded into CDRH's adverse
event database or the submission contained errors (specified in the
acknowledgment) during validation and loading. If your submission
contained errors, the errors need to be corrected and the corrected
reports resent.

II. Description of the Proposed Rule

A. How Would the Rule Address Submission of Reports in Electronic
Format?

    This rule would revise Sec.  803.12 to require that manufacturers,
importers, and user facilities submit postmarket MDRs to the agency in
an electronic format that FDA can process, review, and archive. Under
the proposal, FDA will periodically issue information on

file formats, preparation and organization of files, media, method of
transmission, and other relevant technological specifications for
providing reports in an electronic format that FDA can process, review,
and archive. Proposed new Sec.  803.23 would direct reporters to the
agency's Web site to find the most updated relevant information.
Reports between manufacturers, importers, and user facilities would not
be subject to the requirement of submission in electronic format, and
may be in any format the recipient can read.
    The rule would make conforming changes throughout part 803 to
reflect the proposed requirement to submit reports to FDA in electronic
format. These changes include removing Sec.  803.11, which currently
addresses obtaining paper forms, and removing Sec.  803.14, which
currently provides for voluntary electronic submission of reports with
FDA consent. The proposal would amend Sec.  803.19, which already
addresses exemptions or variances from any of the requirements of part
803, to specifically address exemption or variance from the requirement
to submit reports to FDA in electronic format. Other changes include
removing references to ``electronic equivalent[s] approved under Sec.
803.14'' from Sec. Sec.  803.13, 803.30, 803.33, 803.40, and 803.53,
and updating wording in Sec.  803.20 and 803.56 to be more consistent
with the fact that reports will not be submitted on paper (and thus,
for example, would no longer have a front and back).
    If this proposed rule becomes final, manufacturers, importers, and
user facilities would be required to begin submitting medical device
reports to the agency in electronic format no later than 1 year from
the date of publication of a final rule. After the effective date, the
agency would not accept MDRs submitted on paper copies of the FDA Form
3500A, or in electronic formats other than those identified as ones
that FDA can process, review, and archive in information provided in
conjunction with this rule, unless the agency had granted an exemption
or variance as provided for in Sec.  803.19.
1. How Would the Reporting Requirements for Manufacturers Change With
Respect to Electronic Format?
    The rule would amend Sec. Sec.  803.50(a), 803.53, and 803.56 to
require submission of information required by Sec. Sec.  803.52,
803.53, and 803.56 in electronic format in accordance with Sec.
803.12(a).
2. How Would the Reporting Requirements for Importers Change With
Respect to Electronic Format?
    The proposed rule amends Sec.  803.40(a) to require submission to
FDA of information required by Sec.  803.42 in electronic format in
accordance with Sec.  803.12(a). The proposed electronic format
requirement does not extend to importer reports submitted to device
manufacturers, which may be in any format that the recipient can read.
3. How Would the Reporting Requirements for User Facilities Change With
Respect to Electronic Format, and How Would Annual Report Requirements
be Affected?
    The proposed rule amends Sec.  803.30(a) to require submission to
FDA of information required by Sec.  803.32 in electronic format in
accordance with Sec.  803.12(a). The amendment does not impose
mandatory electronic format requirements on user facility reports
submitted to device manufacturers, which may be provided in any format
the recipient can read.
    The proposed rule also makes certain changes to Sec.  803.33,
addressing user facility annual reports. Under the proposed rule, user
facilities will continue to submit annual reports on the paper FDA Form
3419. Because the proposal to require submission of individual adverse
events reports in electronic format calls for amendments to Sec.
803.12 and for removal of Sec. Sec.  803.11 (indicating how to obtain
paper forms) and 803.14 (addressing voluntary electronic submissions),
FDA is proposing to amend Sec.  803.33 to specify where to obtain the
FDA Form 3419, where to submit completed reports under that section,
and to remove references to Sec.  803.14.
4. How Would the Requirement to Submit Reports in Electronic Format
Affect Recordkeeping Requirements?
    Section 803.18 of the regulation addresses requirements for
establishing and maintaining MDR files or records for manufacturers,
user facilities, and importers. FDA is proposing to amend Sec.
803.18(b)(ii) to require that MDR files contain copies of all reports
submitted under part 803, whether paper or electronic. As under the
current regulations, under the proposal, regulated entities may choose
to maintain required records either in hard copy, by printing out
reports submitted in electronic format, or in electronic form. (For
information regarding FDA's current thinking and enforcement policy
with regard to requirements for maintaining electronic records, see 21
CFR part 11 and the agency guidance document, ``Guidance for Industry:
Part 11, Electronic Records; Electronic Signatures--Scope and
Application,'' available at http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/
ucm072322.pdf5667fnl.pdf.). FDA is also proposing to add Sec.
803.18(b)(1)(iii) to require the retention of all acknowledgments FDA
sends the manufacturer, importer, or user facility when reports are
submitted in electronic format, which will indicate the timing and
success of submission.

B. How Would I Submit MDRs in Electronic Format?

    As noted previously, if the proposed rule is finalized,
manufacturers, importers, and user facilities will be required to
submit most MDRs to the agency in an electronic format that FDA can
process, review, and archive. In order to best accommodate
technological changes, FDA expects to issue information on how to
prepare and submit MDRs to the agency in a way that would satisfy the
requirements of this proposed rule. The most specific and updated
information about how to create, format, and transmit reports, using
the CeSub software (designed for low volume reporting) or the HL7 ICSR
(designed for high volume reporting), is provided on the agency's Web
site, at the address provided in proposed Sec.  803.23. The agency will
make every effort to maintain backwards compatibility when implementing
changes to the systems and formats for electronic submission. When
backwards compatibility is not possible, the agency will provide public
notice with a duration commensurate with the complexity of the change.

C. How Can a Medical Device Manufacturer, Importer, or User Facility
Obtain a Variance Regarding the Requirement to Submit a Report in
Electronic Format?

    Under proposed Sec.  803.19, a manufacturer, importer, or user
facility may submit a written request to FDA seeking a variance of the
Sec.  803.12 requirement to submit reports to the agency in an
electronic format that the agency can process, review, and archive.
Written requests must contain the reason(s) why the reporting entity
requires a variance and for how long the variance is needed. FDA
anticipates receiving few variance requests because of the availability
of the Internet and the commercial availability of digital certificates
as well as FDA's free CeSub Internet software. Under the proposal, if
FDA grants a variance, the

manufacturer, importer, or user facility would be required to submit
MDRs as specified by FDA in the letter authorizing the variance.

D. What Other Changes Are Being Proposed?

    The proposed rule would also codify the following modifications:
    1. FDA proposes to remove the definition of ``Five-day report'' in
Sec.  803.3, which merely referred to a report submitted under Sec.
803.53 (the only provision of the regulation in which the term
appears), using the FDA Form 3500A or ``an electronic equivalent
approved under Sec.  803.14.'' Because this definition is not
necessary, FDA proposes to remove it.
    2. FDA proposes to amend Sec. Sec.  803.32, 803.42, and 803.52 to
make minor wording changes and corrections to these sections to reflect
modifications already made to FDA Form 3500A and its instructions, with
OMB approval under the PRA. For example, section 303 of the Medical
Device User Fee and Modernization Act of 2002 (Public Law 107-250)
required FDA to modify the forms to facilitate reporting of MDRs
involving single-use devices that have been reprocessed for reuse (see
69 FR 7491, February 17, 2004). FDA is proposing to amend Sec. Sec.
803.32, 803.42, and 803.52 to reflect the addition to the FDA Form
3500A of these two questions concerning whether the device is a single
use device that has been reprocessed and reused on a patient and the
name and address of the reprocessor.
    FDA is also proposing to change Sec. Sec.  803.32(b)(4),
803.42(b)(4), and 803.52(b)(4) from ``date of report by the initial
reporter'' to ``date of this report.'' This change would make part 803
consistent with the way that other FDA Centers interpret FDA Form
3500A, Block B4 and how Block B4 appears on FDA Form 3500A. Finally,
FDA is also proposing to make other minor updates to Sec. Sec.
803.32(c), 803.42(c), and 803.52(c) and (e) to reflect the changes
already made to the forms and instructions, including a reference to
the product code and PMA/510(k) number.

E. When Would the Rule Become Effective?

    FDA proposes that any final rule that issues based on this proposal
become effective 1 year after the date the final rule publishes in the
Federal Register.

III. What Is the Legal Authority for This Rule?

    FDA's legal authority to amend its regulations governing the
submission of postmarket medical device adverse event reports for
medical devices derives from 21 U.S.C. 352, 360, 360i, 360j, 371, and
374.

IV. Is There an Environmental Impact?

    The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). This proposed rule has
been determined to be a significant regulatory action.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because we lack information on the electronic
submission capabilities of all the firms potentially affected by this
proposed rule we have not proposed to certify that the proposed rule
would not have a significant economic impact on a substantial number of
small entities. We request commenters to submit such information in
their comments.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that will meet or
exceed this amount.
    The purpose of this proposed rule is to require the submission of
MDRs in an electronic format the agency can process, review, and
archive. It would affect all persons subject to medical device
reporting under part 803, which includes medical device manufacturers,
device importers, and user facilities.
    The proposed rule is part of a greater agency initiative to adopt
electronic technologies to improve the quality of our operations and
increase the efficiency of our resources. The rule would reduce FDA's
current costs associated with processing medical device reports (or
MDRs) that are received on the paper FDA Form 3500A. By receiving MDRs
electronically, FDA would be able to access the adverse event
information more quickly and also eliminate potential data entry errors
that could occur during input transcription of the information from the
paper FDA Form 3500A reports into our electronic medical device adverse
event reporting database.
    After considering various alternatives, FDA determined that without
this regulation, the agency will need to maintain adequate resources to
continue to convert paper 3500A MDRs to electronic MDR records until
all manufacturers, importers, and user facilities voluntarily adopted
the proposed electronic submission format, possibly years in the
future.

A. Benefits

    The major benefit of this proposed rule would be to public health
because the agency would have quicker access to the medical device
adverse event reports information and thus could more quickly identify
and act on any medical device problems. Currently, FDA receives 100,000
initial MDRs annually on the paper FDA Form 3500A, which are manually
entered into the FDA database. FDA receives an additional 110,000
supplemental reports each year that are also submitted on the paper FDA
Form 3500A and need to be processed and entered into the FDA database.
It can take from 3 days to more than 6 months before an MDR submitted
on a paper copy of the FDA Form 3500A may be available for analysis in
the Manufacturer and User Device Experience database (MAUDE). With a
standardized electronic format, medical device reports would become
available for analysis as soon as they are processed into MAUDE. With a
reduction in the time to manually enter the MDRs into the MAUDE
database, analysis and action, including feedback to manufacturers and
consumers, could be taken sooner with a corresponding benefit to public
health.
    The public health benefits would be supplemented with operating
cost reductions within FDA. Assuming the number of MDRs remains fairly
constant over time, electronic reporting would

save the agency about $1.25 million annually in data entry costs, which
is about one-half of our current data entry contract.

B. Costs

    There are about 18,000 medical device manufacturers and importers
identified in FDA's medical device registration database and
approximately 38,500 user facilities identified in the 2002 U.S.
Economic Census that would be affected by the proposed rule (for a
total of 56,500 manufacturers, importers, and user facilities) (Census,
2002). Table 1 shows the estimated numbers of firms and establishments
in the affected industries.

                                   Table 1.--Affected Firms and Establishments
----------------------------------------------------------------------------------------------------------------
      North American Industry                                                                      No. of
Classification System (NAICS) Code             Description                No. of Firms         Establishments
----------------------------------------------------------------------------------------------------------------
Various                             Devices                                         18,000                 8,000
----------------------------------------------------------------------------------------------------------------
622                                 Hospitals                                        3,800                 6,342
----------------------------------------------------------------------------------------------------------------
6231                                Nursing care facilities                          7,826                15,480
----------------------------------------------------------------------------------------------------------------
6214                                Outpatient care centers                         11,125                23,912
----------------------------------------------------------------------------------------------------------------
6215                                Medical and diagnostic                           5,736                 9,844
                                     laboratories
----------------------------------------------------------------------------------------------------------------
6216                                Home health care services                        9,987                15,016
----------------------------------------------------------------------------------------------------------------
Total                                                                               56,474                88,594
----------------------------------------------------------------------------------------------------------------

The incremental cost of changing to electronic submissions for each
affected entity would vary by the size, type, and corporate structure
of the firm, as well as by its current electronic submission
capability. The total costs associated with this proposed rule would
include one-time set-up costs and annual operating costs.
1. One-Time Costs
    One-time costs would be the sum of the costs of:
     Rewriting standard operating procedures (SOPs) and
training the appropriate personnel,
     Installing and validating either the installation of
CDRH's CeSub Web interface software or the programming and
configuration of a computer system to transmit reports directly to the
FDA ESG using the HL7 ICSR, and
     Acquiring the electronic digital certificate required by
the FDA ESG.
    a. Rewriting SOPs and training personnel. All entities affected
would need to update their SOPs to include the electronic submission
requirement. For medical device manufacturers, importers, and
hospitals, we estimate that it would require about 10 hours to make the
modifications and train the appropriate people on the new procedures.
For the other user facilities, we assume that the corporate or regional
offices would have the major responsibility for medical device
reporting and thus the SOPs for these individual entities would require
less time to modify. For this analysis we estimated that 55 percent of
the other user facilities would require about 10 hours to modify their
SOPs and the remaining 45 percent would require about 2 hours.\1\ The
estimated one-time incremental cost for updating SOPs, assuming an
average wage rate of $52 per hour,\2\ (Bureau of Labor Statistics
(BLS), 2006) is about $34.1 million [((18,000 medical device
manufacturers and importers + 6,300 hospitals) x 10 hours) + ((0.45 x 2
hours + 0.55 x 10 hours) x 64,500 other user facilities) x $52/hour].
---------------------------------------------------------------------------

    \1\ Percentages are based on the ratio of firms to
establishments from 2002 Census of Manufactures data.
    \2\ $52 per hour wage is based on BLS Occupational Employment
and Wages, May 2006, for Medical and Health Service Managers,
Standard Occupational Classification 11-19111. Forty percent was
added to the mean hourly wage of $37.09 to account for benefits and
the total was rounded to the nearest whole number.
---------------------------------------------------------------------------

    b. Setting up systems for submission. MDRs would be submitted
through the FDA ESG using one of two methods: The CDRH CeSub software
or the HL7 ICSR. Because most entities are small and submit few if any
MDRs annually, we assume they would probably use the CDRH CeSub
software, which allows for the submission of one MDR at a time. To
comply using this submission method, manufacturers, importers, and user
facilities would need high-speed Internet connections and would have to
download and install up to three free software programs, validate the
installation, and train the appropriate personnel on the new
procedures. Entities that have dedicated information technology (IT)
staff would be able to install and validate the installation
themselves. Smaller manufacturers, importers, and user entities would
probably choose to hire an outside contractor for the installation and
its validation.
    We do not have data on the amount of time required to install and
validate the installation of the software or the percentage of entities
that might need to contract out the installation. For this analysis, we
assumed it would take an entity 8 to 16 hours to install and validate
the installation of CDRH's CeSub software and install, if necessary,
Java Runtime Edition software and Java security policy files for their
Internet browser. This estimate also includes the time required to
notify FDA, run a test submission through the FDA ESG, and to train the
appropriate staff to use the new program. We are also assuming that
almost all medical device manufacturers, importers, and all user
facilities would use this method to submit MDRs. Using an average wage
of $46.50 for computer and mathematical occupations\3\ (BLS 2006), we
estimate the cost to install and use the software to be between $21.0
million and $41.7 million [(8 hours x $46.50 wage) x (38,500 user
facilities + 18,000 manufacturers and importers) to (16 hours x $46.50
wage) x (38,500 user facilities + 18,000 manufacturers and importers)].
---------------------------------------------------------------------------

    \3\ BLS Occupation Employment and Wages, May 2006, by
occupation, for all industries (http://www.bls.gov). Wage ($46.50)
includes mean hourly wage of $33.22 for Standard Occupational
Classification 15-0000, computer and mathematics occupations, all
industries; we add 40 percent to account for benefits.
---------------------------------------------------------------------------

    Entities that submit a large number of MDRs each year may choose to
use the HL7 ICSR method to submit the reports.

This method allows for the batch submission of multiple MDRs at faster
transmission rates. We do not know at what threshold of reporting it
becomes cost effective for an entity to submit medical device reports
using this method. An analysis of FDA submission data for a 6-year
period indicated that about 20 large medical device manufacturers
submit 500 or more MDRs each year and about 85 submit close to 100
medical device reports per year. We assumed that the actual number of
entities using the HL7 ICSR would fall somewhere within this range (20
to 85). We also assumed that only entities that have existing
infrastructure to support HL7 ICSR transmissions would choose this
method to submit MDRs. We estimated that it would take about 50 hours
to set up their gateway to be compatible with the agency's system.
Using the wage $46.50, the one-time cost for establishing HL7 ICSR
submission capabilities would range between $50 thousand and $200
thousand [($46.50 x 50 hours) x 20 entities) and ($46.50 x 50 hours) x
85 entities)].
    c. Electronic certificates. All entities would need an electronic
certificate to submit any electronic regulatory document to the FDA
ESG. The electronic certificate identifies the sender and serves as an
electronic signature. Entities that have not submitted any electronic
documents to the agency would incur a one-time cost to acquire the
certificate and recurring costs to keep the certificate active as a
result of this proposed rule. The certificates cost about $20 and are
valid for 1 year. We assume that the search and transactions costs
involved in the initial acquisition of the certificate doubles the cost
of the certificate to a total of $40 for the first year, half of which
would be setup costs. If all entities needed to acquire electronic
certificates, the one-time search and acquisition costs would be $1.1
million ($20 acquisition cost x 56,500 entities).
    In addition to the costs we have estimated, manufacturers,
importers, and user facilities affected by this proposed rule may have
to hire outside expertise to install and validate the software
installation to comply with the proposed requirements.
    Table 2 summarizes the estimated one-time costs by type of cost for
this proposed rule by cost and type of manufacturers, importers, and
user entities. The estimate of the total one-time costs for all
manufacturers, importers, and user facilities ranges from $58.6 million
to $79.7 million. Much of the cost involves acquiring the electronic
certificate for the capability to submit any regulatory document to the
FDA, including installation and validation of the CeSub software or to
establish HL7 ICSR capabilities. Therefore, manufacturers, importers,
and user facilities that are not already making electronic submissions
of any kind to the agency if this proposed rule becomes final would
incur these total costs.

                           Table 2.--Summary of One-Time Costs by Industry ($ Million)
----------------------------------------------------------------------------------------------------------------
                         Install and validate       Gateway to gateway                            Total
           Modifying        CeSub software      -------------------------- Acquiring e--------------------------
Industry      SOPs    --------------------------                           certificate
                           low          high         low          high                      low          high
----------------------------------------------------------------------------------------------------------------
Medical          9.4          6.7         13.4          0.05         0.2          0.4         16.6         23.4
 Device
----------------------------------------------------------------------------------------------------------------
User            26.9         14.3         28.6   ...........  ...........         0.8         42.0         56.3
 Facilit
 y
----------------------------------------------------------------------------------------------------------------
Total           36.3         21.0         42.0          0.05         0.2          1.2         58.6         79.7
----------------------------------------------------------------------------------------------------------------
Annualized at 3 percent over 10 years                                                          6.9          9.3
----------------------------------------------------------------------------------------------------------------
Annualized at 7 percent over 10 years                                                          8.3         11.4
----------------------------------------------------------------------------------------------------------------

2. Annual Costs
    The annual costs of this proposed rule would include the costs of:
     Maintaining certificates and
     High-speed Internet access.
    a. Maintaining electronic certificates. Manufacturers, importers,
and user facilities would bear the cost to maintain the electronic
certificate that identifies the sender. In addition to having to renew
the certificate on a regular basis, those entities who have not
submitted MDRs would also have to ensure they are capable of
transmitting electronic MDRs to FDA should such a report submission be
necessary. To add these costs to the cost of the certificate itself, we
assume that entities would incur an additional annually recurring cost
equal to one-half the price of the certificate ($10), for a total
annually recurring cost of $30. If all manufacturers, importers, and
user facilities need to acquire electronic certificates, the annual
cost would be $1.7 million ($30 acquisition certificate renewal and
acquisition cost x 56,500 entities).
    b. High-speed Internet access. Entities would also need high-speed
Internet access to use either of the submission methods. A 2004 study
of small businesses sponsored by the Small Business Administration
(SBA) found that essentially all small firms had Internet access and
about 50 percent had high-speed Internet access (Pociask, 2004). The
average cost of high speed access was about $40 per month more than
dial-up access. Because the average cost of Internet access has been
going down over time, we estimate that by the time this proposed rule
would be made final, about 75 percent of device and user facilities
would have high speed access. The average annual recurring increase in
cost for high speed Internet access for the remaining 25 percent of the
entities would be $6.8 million (($40 x 12 months) x (0.25 x (18,000
manufacturers and importers + 38,500 user facilities))).
    Table 3 shows the annual costs of the proposed rule. As with the
one-time costs, only entities not making electronic regulatory document
submissions of any kind to the agency if this proposed rule becomes
final would incur all these costs. There would be no change in the
actual time required to research and prepare the MDRs, nor would there
be any additional reporting requirements as a result of this proposed
rule. Manufacturers, importers, and user facilities that maintain paper
FDA Form 3500A records for their internal MDR files own use could still
do so under the proposed rule.

                            Table 3.--Summary of Annual Costs by Industry ($ million)
----------------------------------------------------------------------------------------------------------------
                                                        Acquiring
                     Industry                           electronic      High-speed Internet         Total
                                                       certificate             access
----------------------------------------------------------------------------------------------------------------
Medical Device                                                     0.5                  2.2  ...................
----------------------------------------------------------------------------------------------------------------
User Facility                                                      1.2                  4.6  ...................
----------------------------------------------------------------------------------------------------------------
Total                                                              1.7                  6.8                  8.5
----------------------------------------------------------------------------------------------------------------

    Cost savings: We estimate a modest industry savings of about $3.2
million annually because electronic submission should reduce the time
it takes to submit documents. It should be noted that the savings
accumulate to firms submitting MDRs; firms that submit very few or no
MDRs would not realize any savings.

C. Summary of Benefits and Costs

    The principal benefit of this proposed rule would be the public
health benefits associated with more rapid processing and analysis of
the 100,000 initial individual MDRs currently submitted to FDA on a
paper FDA Form 3500A. In addition, requiring electronic submission of
MDRs is expected to reduce FDA annual operating costs by $1.25 million
and generate industry savings of about $3.2 million.
    The total one-time cost for modifying SOPs and establishing
electronic submission capabilities is estimated to range from $58.6
million to $79.7 million. Annually recurring costs totaled $8.5 million
and include maintenance of electronic submission capabilities,
including renewing the electronic certificate, and for some entities
the incremental cost to maintain high-speed Internet access. The total
annualized cost of the proposed rule, assuming a 7-percent discount
rate over 10 years, would be from $16.8 million to $19.9 million ($15.4
million to $17.8 million at a 3-percent discount rate). We request
comment on the accuracy and completeness of the assumptions used to
estimate the costs of this proposed rule. For example, we invite
comment on our use of a 10-year time horizon and whether a shorter or a
longer horizon would be more appropriate to express the social costs of
this proposed rule.

D. Alternatives Considered

    During the development of this proposed rule, we considered a
number of alternative approaches. The first was to allow manufacturers,
importers, and user facilities to voluntarily submit MDRs
electronically. Because our experience has shown that a number of
medical device firms and user facilities would resist changing their
procedures for a long period of time, we would not attain the benefits
of standardized formats and quicker access to medical device adverse
event data. The FDA, for example, would have to maintain contracts to
handle the input of information from both written and electronic MDRs.
A voluntary system, therefore, would fail to achieve the goals of this
proposed rule.
    Another alternative was to allow small entities more time to comply
with the electronic submission requirements. This alternative would
allow small entities to delay compliance. Under this alternative, we
would not receive the full data-entry savings from requiring electronic
submissions or all the benefits of quicker access to these reports.
Because so many device companies are small entities, this approach
would significantly postpone the benefits the rule is intended to
confer. Moreover, as shown in the following section, the estimated
incremental costs per small entity from the proposed rule are small, so
the cost reduction per small entity from delayed compliance would also
be small.

E. Regulatory Flexibility Analysis

    The SBA defines a small medical device manufacturer as having fewer
than 500 employees. Based on data from U.S. Census, about 98 percent of
device firms affected by this proposed rule are considered small
entities, and have an average value of shipments of about $9.0
million.\4\ Businesses in the health care industry are classified as
small if their revenues are below a certain level. Hospitals are small
if their total revenue falls below $25 million and the other user
facilities are considered small if their revenues are below $10
million. U.S. Census data indicates that about 87 percent of the user
facilities are classified as small and have a weighted average revenue
of about $3.3 million.\5\ However, very few user facilities submit MDRs
in any given year. While this proposed rule will now require those
reports submitted to the agency to be in electronic format, the content
of a report is not being changed from that already addressed on the
current FDA Form 3500A. The average costs for these manufacturers,
importers, and user facilities are listed in table 4. The average total
annualized cost per small entity, assuming a 7-percent discount rate
over 10 years, would range from $581 to $693; at a 3-percent discount
rate, average annualized costs would range from $568 to $661. These
costs represent less than 0.1 percent of revenues for medical device
firms and less than 0.1 percent of revenues for user facilities.
---------------------------------------------------------------------------

    \4\ U.S. Census Bureau, 2002 Economic Census, Manufacturing
Industry Series, Industry Statistics by Employment Size for NAICS
codes: 334510, 339112, 339113, 339114, and 339115 (www.census.gov).
    \5\ U.S. Census Bureau, 2002 Economic Census, Release Date 11/
22/2005, Sector 62: Health Care and Social Assistance: Subject
Series--Establishment and Firm Size: Receipts/Revenue Size the
United States for NAICS 622, 6231, 6214, 6215, and 6216 accessed via
American Fact Finder (www.census.gov).
---------------------------------------------------------------------------

    We considered two possible alternatives for regulatory relief for
small businesses. As described above, one regulatory alternative would
be longer compliance times for small entities. We would not receive the
full data-entry savings from requiring electronic submissions or all
the benefits of quicker access to these reports. Because so many device
companies are small entities, this approach would significantly
postpone the benefits the rule is intended to confer. Moreover, as
shown above, the estimated incremental costs per small entity from the
proposed rule are small, so the cost reduction per small entity from
delayed compliance would also be small.
    In addition, we considered proposing a waiver to the electronic
submission requirement for small firms that can demonstrate an economic
hardship. Because the estimated incremental costs per small entity from
the proposed rule are small, the cost reduction per small entity from a
waiver would also be small.
    We ask for comments on both of these options for regulatory relief
for small entities.
    While the estimated costs per affected entity are low, FDA does not
have adequate information on the electronic capabilities of all of the
firms affected

by this proposed rule and has made many assumptions to derive these
estimate used in this analysis, therefore we do not propose to certify
that this proposed rule would not have a significant economic impact on
a substantial number of small entities. FDA requests comment on this
issue.

                             Table 4.--Incremental Compliance Costs per Small Entity
----------------------------------------------------------------------------------------------------------------
                                          One-Time  Costs                                Total  Annualized
                                 --------------------------------    Annually    -------------------------------
                                        low            high          Recurring          low            high
----------------------------------------------------------------------------------------------------------------
Rewriting SOPs                               104             520  ..............  ..............  ..............
----------------------------------------------------------------------------------------------------------------
Software Installation and                    372             744  ..............
 validation of installation
----------------------------------------------------------------------------------------------------------------
Acquiring Electronic Certificate                40                ..............
----------------------------------------------------------------------------------------------------------------
Maintaining submission                                                        30
 capabilities
----------------------------------------------------------------------------------------------------------------
Upgrade Internet Access                                                      480  ..............  ..............
----------------------------------------------------------------------------------------------------------------
7 percent discount rate                                           ..............             581             693
----------------------------------------------------------------------------------------------------------------
3 percent discount rate                                           ..............             568             661
----------------------------------------------------------------------------------------------------------------

VI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). A
description of these provisions is given in this document with an
estimate of the annual reporting and recordkeeping burden. Included in
the estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each 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: Medical Device Reporting
    Description: In accordance with the proposed Medical Device
Reporting regulation, medical device manufacturers, importers, and user
facilities would be required to submit MDRs to FDA, to maintain
records, and may also seek exemption or variance from these
requirements. FDA is also proposing to amend Sec. Sec.  803.32, 803.42,
and 803.52 to make minor wording changes and corrections to these
sections to reflect modifications already made to FDA Form 3500A and
its instructions. Manufacturers, importer, and user facilities are
currently submitting paper MDR reports on FDA Form 3500A. The existing
information collection for part 803 is approved under OMB control
number 0910-0437. The changes to the burden associated with this
proposed rule are described below and have been sent to OMB as a
revision to OMB control number 0910-0437 for review under section
307(d) of the PRA.
    Section 519(a)(1) of the act (21 U.S.C. 360i(a)(1)) requires every
manufacturer or importer to report ``whenever the manufacturer or
importer receives or otherwise becomes aware of information that
reasonably suggests that one of its marketed devices--
    (A) may have caused or contributed to a death or serious injury, or
    (B) has malfunctioned and that such device or a similar device
marketed by the manufacturer or importer would be likely to cause or
contribute to a death or serious injury if the malfunction were to
recur * * *''
    Section 519(b)(1)(A) of the act requires ``whenever a device user
facility receives or otherwise becomes aware of information that
reasonably suggests that a device has or may have caused or contributed
to the death of a patient of the facility, the facility shall, as soon
as practicable but not later than 10 working days after becoming aware
of the information, report the information to the Secretary and, if the
identity of the manufacturer is known, to the manufacturer of the
device.''
    Section 519(b)(1)(B) of the act requires ``whenever a device user
facility receives or otherwise becomes aware of: (i) information that
reasonably suggests that a device has or may have caused or contributed
to the serious illness of, or serious injury to, a patient of the
facility * * *, shall, as soon as practicable but not later than 10
working days after becoming aware of the information, report the
information to the manufacturer of the device or to the Secretary if
the identity of the manufacturer is not known.''
    Complete, accurate, and timely adverse event information is
necessary for the identification of emerging device problems so the
agency can protect the public health under section 519 of the act. FDA
is requesting approval for the information collection requirements
contained in part 803.
    Description of Respondents: Manufacturers and importers of medical
devices and device user facilities. Device user facility means a
hospital, ambulatory surgical facility, nursing home, outpatient
diagnostic facility, or outpatient treatment facility as defined in
Sec.  803.3, which is not a physician's office (also defined in Sec.
803.3).
    The total annual estimated burden imposed by this collection of
information is 21,525 hours annually.

                                                       Table 5.--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 No. of        Annual Frequency     Total Annual        Hours per
       21 CFR  Section                FDA  Form No.           Respondents        Per Response        Responses           Response         Total  Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.19                         ..........................                 55                  4                220                  1                220
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.30 and 809.32              ..........................                411                  2                822               0.33                271
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.33                         3419                                      411                  1                411                  1                411
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.40 and 803.42              ..........................                 44                 20                880               0.33                290
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.50 and 803.52              ..........................              1,304                 58             75,632               0.11              8,248
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.56                         ..........................              1,200                 48             57,600               0.10              5,760
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                15,200
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                 Table 6.--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                         No. of         Frequency per       Total Annual
 21 CFR  Section      Respondents       Recordkeeping         Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
803.17                         1,677                  1              1,677                3.3              5,534
----------------------------------------------------------------------------------------------------------------
803.18 (a) to (d)                527                  1                527                1.5                791
----------------------------------------------------------------------------------------------------------------
Total                          2,204  .................              2,204  .................              6,325
----------------------------------------------------------------------------------------------------------------

    The approved MDR reporting and recordkeeping burden for paper
submissions is 138,271 hours. This proposed rule reporting and
recordkeeping burden for electronic submissions is 21,525 hours, a
decrease of 123,071 hours. Based on an average wage rate of $46.50 per
hour, the total cost to respondents associated with these reporting and
recordkeeping burdens is $1,000,913. An explanation for the burden
decrease is provided below.

A. Reporting Requirements

    The number of respondents for each Code of Federal Regulations
(CFR) section in table 5 is based upon the number of respondents
entered into FDA's internal databases. FDA estimates that electronic
submission will decrease the burden associated with Sec. Sec.  803.19,
803.30, 803.32, 803.40, 803.50, 803.52, and 803.56. We believe
electronic submission will neither increase nor decrease burden
associated with Sec.  803.33, which we estimate will take 1 hour. We
believe Sec.  803.19 will take 1 hour, while Sec. Sec.  803.30, 803.32,
803.40, and 803.42 will take 20 minutes. Sections 803.50 and 803.52
will take 7 minutes. Section 803.56 will take 6 minutes. The following
table summarizes our burden estimates and how we believe they will
change due to electronic submission.

                               Table 7.--Estimated Reporting Burden Program Change
----------------------------------------------------------------------------------------------------------------
                                                                    Hours per response
                                              Hours per response       as result of
               21 CFR Section                 under current paper       electronic            Burden Change
                                              submission process        submission
----------------------------------------------------------------------------------------------------------------
803.19                                                          3                  1         Reduction (2 hours)
----------------------------------------------------------------------------------------------------------------
803.30 and 809.32                                               1                  0.33    Reduction (.66 hours)
----------------------------------------------------------------------------------------------------------------
803.33                                                          1                  1                   no change
----------------------------------------------------------------------------------------------------------------
803.40 and 803.42                                               1                  0.33    Reduction (.66 hours)
----------------------------------------------------------------------------------------------------------------
803.50 and 803.52                                               1                  0.11    Reduction (.89 hours)
----------------------------------------------------------------------------------------------------------------
803.56                                                          1                  0.10    Reduction (.90 hours)
----------------------------------------------------------------------------------------------------------------

    As previously described, there are two reporting options. The first
one is CeSub for low volume reporters and the second one is HL7 ICSR
for high volume reporters. We are basing our hours per response for
both systems on FDA's experience using the two options.

B. Recordkeeping Requirements

    The number of respondents for each CFR section in table 6 is based
upon the number of respondents entered into FDA's internal databases.
The agency believes that the majority of manufacturers, user
facilities, and importers have already established written procedures
to document complaints and information to meet the MDR requirements as
part of their internal quality control system. The following table
summarizes our burden estimates and how we believe they will change due
to electronic submission.

                             Table 8.--Estimated Recordkeeping Burden Program Change
----------------------------------------------------------------------------------------------------------------
                                                                       Hours per response
                                                 Hours per response       as result of
                21 CFR Section                   under current paper       electronic           Burden Change
                                                 submission process        submission
----------------------------------------------------------------------------------------------------------------
803.17                                                          10                     3.3        Reduction (7.7
                                                                                hours)
----------------------------------------------------------------------------------------------------------------
803.18 (a) to (d)                                                1.5                   1.5             No change
----------------------------------------------------------------------------------------------------------------

C. Total Annual Cost Burden

    As stated earlier, the cost to respondents for these reporting and
recordkeeping requirements is $1,000,913. In addition, the conversion
from paper to electronic submissions will result in capital costs, both
one-time costs as well as annual costs, as discussed earlier in this
proposed rule in the economic analysis. One-time capital costs include
the cost to modify reporting systems, installing and validating CeSub
software, installing gateway to gateway submission capabilities, and
acquiring e-certificates and have been estimated to range from a low of
$58.6 million to a high of $79.7 million. Once the procedures have been
modified, there is an operating and maintenance cost to renew the
digital certificate and maintain high-speed internet access, which have
been estimated cost $8.5 million each year. Burden estimates are based
on reports processed between July 1, 2005, and June 30, 2006, with the
existing medical device adverse event reporting program.
    In compliance with the PRA, the agency has submitted the
information collection provisions of this proposed rule to OMB for
review. Interested persons are requested to send comments regarding
information collection to OMB (see the DATES and ADDRESSES sections of
this document).

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
this rule does not contain policies that have federalism implications
as defined in the order and, consequently, a federalism summary impact
statement is not required.

VIII. Request for 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.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but is not responsible for
any subsequent changes to the Web site after this document publishes in
the Federal Register.)
    1. U.S. Census Bureau, 2002 Economic Census Industry Series:
NAICS Code 62, Health Care and Social Assistance (http://
www.census.gov). Total is the sum of firms in NAICS 622, 6231, 6214,
6215, and 6216.
    2. BLS Occupational Employment and Wages May 2005 for Medical
and Health Service Managers, Standard Occupational Classification,
11-19111.
    3. Pociask, Steven, A Survey of Small Businesses'
Telecommunications Use and Spending, SBA Office of Advocacy contract
number SBA-HQ-02-M-0493, March 2004.

List of Subjects in 21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend part 803 to read as follows:

PART 803--MEDICAL DEVICE REPORTING

    1. The authority citation for 21 CFR part 803 continues to read as
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

Sec.  803.3  [Amended]

    2. Amend Sec.  803.3 by removing the definition for ``Five-day
report''.

Sec.  803.11  [Removed]

    3. Remove Sec.  803.11.
    4. Revise Sec.  803.12 to read as follows:

Sec.  803.12  How do I submit reports and supplements?

    (a) Manufacturers, user facilities, and importers must submit
initial and supplemental reports to FDA in an electronic format that
FDA can process, review, and archive. FDA will provide and update
information on how to provide the electronic submission (e.g.,
preparation and organization of files, file formats, media and method
of transmission).
    (b) If you are confronted with a public health emergency, this can
be brought to FDA's attention by contacting the FDA Office of Emergency
Operations (HFA-615), Office of Crisis Management, Office of the
Commissioner, at<PHONE_NUMBER>, followed by the submission of an e-mail
to<EMAIL_ADDRESS>Note: This action does not satisfy
your obligation to report under part 803.
    (c) You may submit a voluntary telephone report to the MEDWATCH
office at 800-FDA-1088. You may also obtain information regarding
voluntary reporting from the MEDWATCH office at 800-FDA-1088. You may
also find the voluntary MEDWATCH 3500 form and instructions to complete
it at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/
default.htm.
    5. Revise Sec.  803.13 to read as follows:

Sec.  803.13  Do I need to submit reports in English?

    Yes. You must submit all reports required by this part in English.

Sec.  803.14  [Removed]

    6. Remove Sec.  803.14.
    7. Amend Sec.  803.18 by revising paragraph (b)(1)(ii) and adding
paragraph (b)(1)(iii) to read as follows:

Sec.  803.18  What are the requirements for establishing and
maintaining MDR files or records that apply to me?

* * * * *
    (b)(1) * * *
    (ii) Copies of all reports submitted under this part (whether paper
or electronic), and of all other information related to the event that
you submitted to us or other entities such as an importer, distributor,
or manufacturer.
    (iii) Copies of all electronic acknowledgments FDA sends you in
response to your electronic submissions.
* * * * *
    8. Amend Sec.  803.19 by revising paragraphs (b) and (e) to read as
follows:

Sec.  803.19  Are there exemptions, variances, or alternative forms of
adverse event reporting requirements?

* * * * *
    (b) If you are a manufacturer, importer, or user facility, you may
request an exemption or variance from any or all of the reporting
requirements in this part, including the requirements of Sec.
803.12(a). You must submit the request to us in writing at the
following address: MDR Exemption Requests, Office of Surveillance and
Biometrics (HFZ-530), 1350 Piccard Dr., Rockville, MD 20850. Your
request must include information necessary to identify you and the
device; a complete statement of the request for exemption, variance, or
alternative reporting; and an explanation why your request is
justified. If you are requesting a variance to the requirement to
submit reports to FDA in electronic format, under Sec.  803.12(a), your
request should indicate for how long you would require this variance.
* * * * *
    (e) If we grant your request for a reporting modification, you must
submit any reports or information required in our approval of the
modification. The conditions of the approval will replace and supersede
the regular reporting requirement specified in this part until such
time that we revoke or modify the alternative reporting requirements in
accordance with paragraph (d) of this section, or until the date
specified in our response granting your variance, at which time, the
provisions of this part will again apply.
    9. In Sec.  803.20, revise paragraph (a), redesignate paragraphs
(b) and (c) as paragraphs (c) and (d), and add new paragraph (b) to
read as follows:

Sec.  803.20  How do I complete and submit an individual adverse event
report?

    (a) If you are a health professional or consumer, you may submit
voluntary reports to FDA regarding devices or other FDA-regulated
products using the FDA Form 3500.
    (b) A mandatory electronic submission from a user facility,
importer, or manufacturer, must contain the information from the
applicable blocks of FDA Form 3500A. All electronic submissions must
include information about the patient, the event, the device, and the
``initial reporter.'' An electronic submission from a user facility or
importer must include the information from block F. An electronic
submission from a manufacturer must include the information from blocks
G and H. If you are a manufacturer and you receive a report from a user
facility or importer, you must incorporate that information in your
electronic submission and include any corrected or missing information.
* * * * *
    10. Add Sec.  803.23 to read as follows:

Sec.  803.23  Where can I find information on how to prepare and submit
an MDR in electronic format?

    (a) You may obtain information on how to prepare and submit reports
in an electronic format that FDA can process, review, and archive at
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
    (b) We may sometimes update information on how to prepare and
submit reports electronically. If we do make modifications, we will
ensure that we alert reporters by updating the eMDR Web page.
    11. Amend Sec.  803.30 by revising paragraphs (a)(1) and (a)(2) to
read as follows:

Sec.  803.30  If I am a user facility, what reporting requirements
apply to me?

    (a) * * *
    (1) Reports of death. You must submit a report to us as soon as
practicable but no more than 10 work days after the day that you become
aware of information, from any source, that reasonably suggests that a
device has or may have caused or contributed to the death of a patient
of your facility. You must also submit the report to the device
manufacturer, if known. You must submit the information required by
Sec.  803.32. Reports sent to the agency must be submitted in
accordance with the requirements of Sec.  803.12(a).
    (2) Reports of serious injury. You must submit a report to the
manufacturer of the device no later than 10 work days after the day
that you become aware of information, from any source, that reasonably
suggests that a device has or may have caused or contributed to a
serious injury to a patient of your facility. If the manufacturer is
not known, you must submit the report to us. You must report
information required by Sec.  803.32. Reports sent to the agency must
be submitted in accordance with the requirements of Sec.  803.12(a).
* * * * *
    12. Amend Sec.  803.32 by revising paragraphs (b)(4) and (c) to
read as follows:

Sec.  803.32  If I am a user facility, what information must I submit
in my individual adverse event reports?

* * * * *
    (b) * * *
    (4) Date of this report;
* * * * *
    (c) Device information (Form 3500A, Block D). You must submit the
following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/ patient,
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and
reused on a patient (yes to paragraph (c)(8) of this section), the name
and address of the reprocessor;
    (10) Whether the device was available for evaluation and whether
the device was returned to the manufacturer; if so, the date it was
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report
products that were used to treat the event.)
* * * * *
    13. Revise Sec.  803.33 to read as follows:

Sec.  803.33  If I am a user facility, what must I include when I
submit an annual report?

    (a) You must submit to us an annual report on FDA Form 3419. You
must submit an annual report by January 1, of each year. You may obtain
this form from any of the following:
    (1) The Consolidated Forms and Publications Office, Beltsville
Service Center, 6351 Ammendale Rd., Landover, MD 20705;
    (2) FDA, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857,
301-827-7240;
    (3) Division of Small Manufacturers, International, and Consumer
Assistance, Office of Communication, Education, and Radiation Programs,
Center for Devices and Radiological Health (CDRH) (HFZ-220), 1350
Piccard Dr., Rockville, MD 20850, by e-mail<EMAIL_ADDRESS>or
FAX:<PHONE_NUMBER>; or
    (4) On the Internet at http://www.fda.gov/Safety/MedWatch/
HowToReport/DownloadForms/default.htm.
    (b) You must clearly identify your annual report as such. You must
submit your annual report to FDA, CDRH, Medical Device Reporting, P.O.
Box 3002, Rockville, MD 20847-3002. Your annual report must include:

    (1) Your CMS provider number used for medical device reports, or
the number assigned by us for reporting purposes in accordance with
Sec.  803.3;
    (2) Reporting year;
    (3) Your name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the annual report and report numbers identifying the
range of medical device reports that you submitted during the report
period (e.g.,<PHONE_NUMBER>-2007-0001 through 1000);
    (6) Name, position title, and complete address of the individual
designated as your contact person responsible for reporting to us and
whether that person is a new contact for you; and
    (7) Information for each reportable event that occurred during the
annual reporting period including:
    (i) Report number;
    (ii) Name and address of the device manufacturer;
    (iii) Device brand name and common name;
    (iv) Product model, catalog, serial and lot number;
    (v) A brief description of the event reported to the manufacturer
and/or us; and
    (vi) Where the report was submitted, i.e., to the manufacturer,
importer, or us.
    (c) In lieu of submitting the information in paragraph (b)(7) of
this section, you may submit a copy of each medical device report that
you submitted to the manufacturers and/or to us during the reporting
period.
    (d) If you did not submit any medical device reports to
manufacturers or us during the time period, you do not need to submit
an annual report.
    14. Revise Sec.  803.40 to read as follows:

Sec.  803.40  If I am an importer, what reporting requirements apply to
me?

    (a) Reports of deaths or serious injuries. You must submit a report
to us, and a copy of this report to the manufacturer, as soon as
practicable, but no later than 30 calendar days after the day that you
receive or otherwise become aware of information from any source,
including user facilities, individuals, or medical or scientific
literature, whether published or unpublished, that reasonably suggests
that one of your marketed devices may have caused or contributed to a
death or serious injury. You must submit the information required by
Sec.  803.42. Reports must be submitted in accordance with the
requirements of Sec.  803.12(a).
    (b) Reports of malfunctions. You must submit a report to the
manufacturer as soon as practicable but no later than 30 calendar days
after the day that you receive or otherwise become aware of information
from any source, including user facilities, individuals, or through
your own research, testing, evaluation, servicing, or maintenance of
one of your devices, that reasonably suggests that one of your devices
has malfunctioned and that this device or a similar device that you
market would be likely to cause or contribute to a death or serious
injury if the malfunction were to recur. You must submit the
information required by Sec.  803.42.
    15. Amend Sec.  803.42 by revising paragraphs (b)(4) and (c) to
read as follows:

Sec.  803.42  If I am an importer, what information must I submit in my
individual adverse event reports?

* * * * *
    (b) * * *
    (4) Date of this report;
* * * * *
    (c) Device information (Form 3500A, Block D). You must submit the
following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient,
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and
reused on a patient (yes to paragraph (c)(8) of this section), the name
and address of the reprocessor;
    (10) Whether the device was available for evaluation and whether
the device was returned to the manufacturer; if so, the date it was
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report
products that were used to treat the event.)
* * * * *
    16. Amend Sec.  803.50 by revising paragraph (a) introductory text
and paragraph (b)(3) to read as follows:

Sec.  803.50  If I am a manufacturer, what reporting requirements apply
to me?

    (a) If you are a manufacturer, you must report to us the
information required by Sec.  803.52 in accordance with the
requirements of Sec.  803.12(a), no later than 30 calendar days after
the day that you receive or otherwise become aware of information, from
any source, that reasonably suggests that a device that you market:
* * * * *
    (b) * * *
    (3) You are also responsible for conducting an investigation of
each event and evaluating the cause of the event. If you cannot submit
complete information on a report, you must provide a statement
explaining why this information was incomplete and the steps you took
to obtain the information. If you later obtain any required information
that was not available at the time you filed your initial report, you
must submit this information in a supplemental report under Sec.
803.56 in accordance with the requirements of Sec.  803.12(a).
    17. Amend Sec.  803.52 by revising paragraphs (b)(4), (c), and (e)
to read as follows:

Sec.  803.52  If I am a manufacturer, what information must I submit in
my individual adverse event reports?

* * * * *
    (b) * * *
    (4) Date of this report;
* * * * *
    (c) Device information (Form 3500A, Block D). You must submit the
following:
    (1) Brand name;
    (2) Product code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient,
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and
reused on a patient (yes to paragraph (c)(8) of this section), the name
and address of the reprocessor;
    (10) Whether the device was available for evaluation and whether
the device was returned to the manufacturer; if so, the date it was
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report
products that were used to treat the event.)
* * * * *

    (e) Reporting information for all manufacturers (Form 3500A, Block
G). You must submit the following:
    (1) Your reporting office's contact name and address and device
manufacturing site;
    (2) The contact's telephone number;
    (3) Your report sources;
    (4) Date received by you (month, day, year);
    (5) PMA/510k Number and whether or not the product is a combination
product;
    (6) Type of report being submitted (e.g., 5-day, initial,
followup); and
    (7) Your report number.
* * * * *
    18. Revise the introductory text of Sec.  803.53 to read as
follows:

Sec.  803.53  If I am a manufacturer, in which circumstances must I
submit a 5-day report?

    You must submit a 5-day report to us with the information required
by Sec.  803.52 in accordance with the requirements of Sec.  803.12(a)
no later than 5 work days after the day that you become aware that:
* * * * *
    19. Amend Sec.  803.56 by revising the introductory text and
paragraphs (a) and (c) to read as follows:

Sec.  803.56  If I am a manufacturer, in what circumstances must I
submit a supplemental or followup report and what are the requirements
for such reports?

    If you are a manufacturer, when you obtain information required
under this part that you did not provide because it was not known or
was not available when you submitted the initial report, you must
submit the supplemental information to us within 30 calendar days of
the day that you receive this information. You must submit the
supplemental or followup report in accordance with the requirements of
Sec.  803.12(a). On a supplemental or followup report, you must:
    (a) Indicate that the report being submitted is a supplemental or
followup report;
* * * * *
    (c) Include only the new, changed, or corrected information.

    Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19683 Filed 8-20-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: September 25, 2008 (Volume 73, Number 187)]
[Notices]
[Page 55521]
[DOCID:fr25se08-60]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1786-DR]

Louisiana; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Louisiana (FEMA-1786-DR), dated September 2, 2008, and
related determinations.

DATES: Effective Date: September 16, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Louisiana is hereby amended to include the Hazard
Mitigation Grant Program for following areas among those areas
determined to have been adversely affected by the catastrophe declared
a major disaster by the President in his declaration of September 2,
2008.

    Natchitoches and Winn Parishes for Public Assistance (already
designated for emergency protective measures [Category B], including
direct Federal assistance, under the Public Assistance program).
    Acadia, Ascension, Assumption, East Baton Rouge, Iberia,
Iberville, Jefferson, Lafourche, Livingston, Plaquemines, Pointe
Coupee, St. Bernard, St. James, St. Landry, Vernon, West Baton
Rouge, and West Feliciana Parishes for Public Assistance (already
designated for Individual Assistance and debris removal and
emergency protective measures [Categories A and B], including direct
Federal assistance, under the Public Assistance program).
    Catahoula, Grant, La Salle, St. Helena, Tangipahoa, and
Washington Parishes for Public Assistance (already designated for
Individual Assistance and emergency protective measures [Category
B], including direct Federal assistance, under the Public Assistance
program).
    All parishes in the State of Louisiana are eligible to apply for
assistance under the Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-22559 Filed 9-24-08; 8:45 am]

BILLING CODE 9110-10-P