[Federal Register Volume 64, Number 244 (Tuesday, December 21, 1999)]
[Proposed Rules]
[Pages 71347-71354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33003]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 807
[Docket No. 99N-4784]
Premarket Notification; Requirement for Redacted Version of
Substantially-Equivalent Premarket Notification
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 premarket notification regulations to require applicants to submit
a redacted version of each premarket notification submission for which
FDA has issued an order declaring a device to be substantially
equivalent to a legally marketed predicate device. The purpose of this
requirement is to provide applicants improved opportunity to protect
nonpublic information contained in their premarket notifications while
facilitating the release of information to which the public is entitled
under the Federal Food, Drug, and Cosmetic Act (the act); the Freedom
of Information Act; and FDA's Public Information regulations. The
proposed rule does not require submission of a redacted version of any
premarket notification received by FDA prior to the effective date of
the regulation.
DATES: Submit written comments by March 22, 2000. Submit written
comments on the information collection requirements by January 20,
2000.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit written comments on information collection
requirements to the Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB), New Executive Office Bldg., 725
17th St. NW., Washington, DC 20503, Attn: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Regulations Staff
(HFZ-215), Center for Devices and Radiological Health, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20857, 301-827-
2974.
SUPPLEMENTARY INFORMATION:
I. Background
Under the act, 21 U.S.C. 301 et seq., FDA clears medical devices
for commercial distribution in the United States through three
regulatory processes: Premarket approval (PMA), product development
protocol (PDP), and premarket notification (a premarket notification is
generally referred to as a ``510(k)'' after the section of the act
where the requirement is found). In addition, a significant number of
devices have been exempted, subject to the limitations on exemptions,
from any requirement to obtain premarket notification clearance because
FDA has determined that the remaining general controls and special
controls are adequate to provide a reasonable assurance of the safety
and effectiveness of those devices. A variety of general controls, such
as good manufacturing practices (GMP's), establishment registration and
device listing, and Medical Device Reporting (problem reporting), and
special controls for class II devices, are applicable to devices
exempted from premarket notification to control the risks presented by
these devices. For additional information on exemption from premarket
notification, see 21 CFR 807.85 and FDA's medical device classification
regulations, 21 CFR parts 862 through 892.
A. Premarket Notification
Of the three regulatory processes used by FDA to clear medical
devices for commercial distribution, the premarket notification or
510(k) process is the most commonly used. The following table 1
summarizes FDA's experience during fiscal year (FY) 1998:
Table 1.--Product Applications Processed During FY 1998
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notifications Premarket Approval Applications Product Development Protocols
Responsible center -----------------------------------------------------------------------------------------------------------------
Received Clear Received Approved Received Approved\1\ Complete
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER 33 44 2 0 0 0 0
CDRH 4,623 3,824 55 46 11 4 0
All FDA 4,656 3,868 57 46 11 4 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Approval of a PDP protocol does not constitute marketing approval. A Notice of Completion must be submitted and approved before a device may be
marketed under a PDP.
The purpose of a premarket notification is to demonstrate that the
new device is substantially equivalent to a legally-marketed predicate
device. A predicate device can be any of the following: A device
legally marketed prior to May 28, 1976 (the date the Medical Device
Amendments of 1976 and its premarket notification requirement became
law); a device which has been reclassified from class III into class I
or class II (the act provides three classes of devices: Class I devices
are regulated primarily through general controls, such as registration,
listing, and GMP's; class II devices are subject to both general
controls and special controls, such as performance standards; class III
devices are subject to general and special controls and must also
undergo premarket review and approval); or a device which has been
found to be substantially equivalent through the 510(k) premarket
notification process.
Under section 513(i) of the act (21 U.S.C. 360c), a device is
substantially equivalent if it has the same intended use and
technological characteristics as a predicate device, or has different
characteristics but data demonstrate that the new device is as safe and
effective as the predicate device and does not
[[Page 71348]]
raise different issues of safety or efficacy. A device that is not
shown to be substantially equivalent to a predicate device can be
marketed only after the sponsor submits, and obtains FDA approval of, a
PMA or notice of completion of a PDP, unless the device is reclassified
into class I or class II under section 513(e) or section 513(f) of the
act.
B. Statutory and Regulatory Requirements Relating to Release of
Information in a 510(k)
Certain information in a 510(k) that has been cleared by FDA (i.e.,
found to be substantially equivalent to a legally-marketed predicate
device) is subject to public disclosure under section 513(i)(3) of the
act. That section and FDA's implementing regulations require applicants
to provide FDA with an adequate summary (510(k) summary) of any
information in their submission regarding safety and effectiveness for
disclosure by FDA upon request, or alternatively, to submit a statement
(510(k) statement) to FDA promising that they themselves will make
certain 510(k) information available to the public upon request.
A second Federal statute relevant to the release of 510(k)
information is the Freedom of Information Act (FOIA), 5 U.S.C. 552. The
FOIA generally makes available for public disclosure all records in an
agency's files, whether created by or submitted to the agency, except
to the extent those records are covered by one or more of the nine
exemptions enumerated in the statute (5 U.S.C. 552(b)). In particular,
exemption 4 of FOIA protects from mandatory disclosure trade secrets
and confidential commercial information (5 U.S.C. 552(b)(4)). In
addition, the act requires withholding of trade secret information from
the public, 21 U.S.C. 331(j), and the Trade Secrets Act also prohibits
disclosure of trade secrets and confidential commercial information
unless specifically authorized by law, 18 U.S.C. 1905. Accordingly,
when FDA receives FOIA requests for 510(k) records (other than 510(k)
summaries, which are intended for public disclosure as submitted by the
applicant) trade secret and confidential commercial information will
ordinarily be redacted (i.e., deleted) before the materials are
released to the public. Prior to making final decisions about
redactions and releasing these records to the public, FDA currently
solicits the 510(k) holders' views on what information in their 510(k)
submissions may be released to the public and what information may
properly be withheld as exempt under FOIA. This practice is consistent
with Executive Order 12600, which required agencies to establish
predisclosure notification procedures under FOIA to protect
confidential commercial information in the agencies' files.
In addition to FOIA's exemption from disclosure for trade secrets
and confidential commercial information, FOIA permits the Government to
withhold information about individuals in personnel, medical, and
similar files, when the disclosure of such information would constitute
a clearly unwarranted invasion of personal privacy (5 U.S.C.
552(b)(6)). With regard to 510(k)s, the issue of personal privacy
protection occasionally arises when medical records or other data with
patient identifiers are included or summarized in a 510(k). FDA's
regulations implementing FOIA request applicants to delete names or
other information that could identify patients or research subjects
prior to submitting records to FDA, and require FDA to delete such
information from any records it discloses (21 CFR 20.63). Similarly,
FDA's regulations relating to 510(k)s require those 510(k) holders who
submitted a 510(k) statement to FDA to delete such information before
releasing a 510(k) (Sec. 807.93(c) (21 CFR 807.93(c))). (Submission of
a 510(k) statement obligates the firm to provide a copy of an
appropriately-redacted 510(k) to any requestor.)
Except for information that is exempt from disclosure under FOIA,
all information in a 510(k) submission is available for disclosure to
the public once the 510(k) is cleared. This includes the original
submission, correspondence with FDA, memoranda of telephone
conversations, amendments, or other supplemental information submitted
prior to clearance of the 510(k) by FDA.
C. Predisclosure Notification and Other Issues Relating to FOIA
Requests for 510(k)s
When a request is received for a particular 510(k) that has not
been previously released under FOIA, FDA provides the 510(k) holder
with a ``predisclosure notification'' in accordance with Executive
Order 12600. Subject to certain exceptions, Executive Order 12600
requires the Government to notify submitters of records containing
confidential commercial information prior to disclosure of those
records in response to a FOIA request. The submitter is then permitted
an opportunity to object to the disclosure of any part of the records
and to state the basis for each such objection. FDA's predisclosure
notification procedures implementing Executive Order 12600 are set
forth at Sec. 20.61(d) through (f) (21 CFR 20.61(d) through (f)).
It has been FDA's experience that many 510(k) holders who are
provided predisclosure notification by the agency fail to respond
adequately; they may not provide an appropriately redacted 510(k), not
offer reasons to support redactions, or not respond at all. One reason
for this occurrence is that, given the tight statutory timeframes FDA
faces for responding to FOIA requests, the 510(k) holder can only be
given a very short time to respond to the predisclosure notification;
Sec. 20.61(e)(2) requires a response in 5 working days. A second reason
is that by the time a FOIA request is filed and predisclosure
notification is given, a significant period of time may have passed
since the 510(k) was cleared by FDA. As a result, the team of experts
at the submitter company that contributed to the development of the
510(k) submission may not be readily available to respond to the
predisclosure notification and will, in any case, have to spend time
reviewing the 510(k) to refresh recollections and identify trade
secrets or confidential commercial information that may be protected
from public disclosure.
In addition, because there is no requirement at present for a
510(k) holder to inform FDA when ownership of the 510(k) is transferred
to a new party, FDA has, in many instances, been unable to locate and
verify the current 510(k) holder for purposes of sending predisclosure
notification. Many other 510(k) holders simply fail to respond at all
to FDA's predisclosure notification. Consequently, FDA assumed the job
of unilaterally redacting many 510(k)s when responding to FOIA requests
for those records. As FDA has invested more time and effort in
redacting 510(k)s, the resources devoted to responding to 510(k) FOIA
requests has inevitably increased. At times, this has resulted in
significant backlogs that have delayed the release of information to
the public and diverted limited agency resources from other
responsibilities, including support for premarket review and postmarket
surveillance.
II. Procedural Amendments
The proposed rule would amend Sec. 807.87 (21 CFR 807.87) to
require 510(k) applicants to include a statement that would commit the
applicant to provide a redacted version of the 510(k) within 30 days of
FDA's finding the device substantially equivalent. Proposed Sec. 807.91
sets forth the statement that must be submitted. The statement is
referred to as a
[[Page 71349]]
``commitment to submit a redacted 510(k).'' The redacted version is one
that can be immediately released in response to a freedom of
information request, published on the Internet, or otherwise made
available to the public. The redacted version would include all
sections of the 510(k) submission, including amendments, supplements,
and all other documents included in the 510(k) submission, except to
the extent that information may be appropriately redacted that is
exempt from disclosure under FOIA, such as trade secrets, confidential
commercial information, and personal privacy information.
The requirement to provide the redacted version within 30 days of
FDA's decision is consistent with the statutory time set by section
513(i) of the act for submission of a 510(k) summary or statement.
Although FOIA requires FDA to respond to FOIA requests within 20 days,
FDA believes it is unlikely that there will be a real conflict between
these two timeframes. This is because FDA publishes a list of 510(k)
clearances about the same time each month, resulting in a lag time of
at least 5 days, and up to 35 days, between the time of FDA's decision
and the announcement of the decision. Although a 510(k) submitter may
disclose the clearance of a 510(k) before FDA does, FDA believes it is
extremely unlikely that the clearance would be made known and a FOIA
request submitted so rapidly that the FDA response would be delayed due
to the 30 days applicants would be permitted to provide a redacted
version of the 510(k) to FDA.
Applicants would be permitted to use either of two techniques to
redact information: (1) The entire 510(k) may be resubmitted with the
information to be withheld from disclosure physically obscured to
render it unintelligible (e.g., by covering the text or figure with
black ink), or (2) the information to be withheld may be omitted from
the redacted version, but the extent of each deletion must be described
at the place in the document where the redaction was made (e.g., an
indication that ``pages 12 through 15 have been redacted'' or
``paragraph concerning sources of raw materials has been deleted'').
Simply providing FDA with written instructions such as, ``please do not
release Section IV,'' and then expecting FDA to follow those
instructions to locate and redact the information as specified by the
applicant would be insufficient to comply with the requirement to
submit a 510(k) already redacted of information that is exempt from
disclosure to the public.
FDA encourages, but would not require, the redacted version to be
submitted on disk, preferably as a portable document format file (.pdf
file). Submission of .pdf files will facilitate FDA's release of
information in electronic form, thereby assisting FDA in complying with
its new obligations under the Electronic Freedom of Information Act
Amendments of 1996 (EFOIAA) to make reasonable efforts to furnish
records in an electronic format when requested to do so.
The proposed rule does not address the redaction of 510(k)s
submitted to FDA prior to the effective date of the regulation. FDA
will continue to provide predisclosure notification for those documents
under the existing approach for the 10 years following their date of
submission to the agency (Executive Order 12600 requires predisclosure
notification for 10 years following submission of a document), and will
address redaction of these 510(k)s on a case-by-case basis using FDA's
current approach. Eighty percent of recent FOIA requests for 510(k)s
have been for files less than 2 years old. Consequently, the agency
expects most of its current predisclosure notification workload to be
significantly reduced over time.
The requirement to provide a redacted 510(k) within 30 days of
FDA's clearance is expected to provide 510(k) applicants and holders
two significant benefits:
First, this approach would permit applicants to consider and
address FOIA disclosure issues during and immediately following the
development and assembly of the 510(k), while the expert team that
contributed to the development of the 510(k) is available and engaged.
FDA believes it will be significantly easier and less expensive for the
applicant to deal with FOIA disclosure issues at an early stage rather
than having to reassemble experts to review the 510(k) and resolve
disclosure issues at some indeterminate time in the future.
Second, FDA believes this approach would permit applicants to have
a larger voice in determining what information would be protected from
disclosure. Indeed, this approach recognizes that the firm is in a
uniquely well-qualified position to identify trade secret and
confidential commercial information relating to its own 510(k)
submission. Currently, FDA assumes the entire responsibility for
designating what information is considered trade secret or other
confidential information in a 510(k) when it cannot locate the current
owner of the 510(k) or when the owner fails to respond to predisclosure
notification within an appropriate time. Because FDA is unlikely to
have all the information that would be available to the submitter, FDA
may not identify trade secret and confidential commercial information
in the 510(k) in the same way as the 510(k) holder would have done.
In addition to these two direct benefits, device applicants would
also benefit indirectly from the approach set forth in the proposed
rule because FDA would be able to free some resources it currently
spends on efforts to determine what information should be protected
from disclosure. Therefore the focus would be on those resources
instead on activities more directly related to the device review
process.
The proposed rule would benefit FDA in two key ways:
1. It would eliminate the need to routinely provide individual
predisclosure notification to 510(k) holders when a 510(k) is requested
under FOIA; currently, 510(k) submissions are the only significant
category of records maintained by FDA that requires predisclosure
notification. Given the significant volume of FOIA requests for 510(k)s
and the time and effort required to process them under the current
system, adopting the approach established by the proposed rule would
significantly improve FDA's ability to provide timely responses to FOIA
requests for 510(k)s and at the same time would allow the agency to
redirect resources to product reviews and other activities more closely
related to the agency's public health mission.
2. As discussed above, the regulation would ensure that the party
that is in the best position to identify trade secret and confidential
commercial information assumes primary responsibility for redacting
that information.
The proposed rule will benefit the public by making information to
which the public is entitled available in a more timely manner and at
lower cost.
A. Copyrighted Information Provided in a 510(k)
Submitters of 510(k)s occasionally provide copyrighted materials to
FDA in support of their submissions. When a FOIA request is received
for a 510(k) that includes copyrighted materials, FDA may include a
copy of any of those materials in response to the request, except to
the extent that such materials are exempt under FOIA exemption four.
FDA's disclosure of nonexempt information contained in copyrighted
materials in response to a FOIA request is generally considered a
``fair use under the Copyright Act of 1976 (17 U.S.C. 101
[[Page 71350]]
et seq.) and, thus, does not constitute copyright infringement. See 17
U.S.C. 107, and Office of Information and Privacy, U.S. Department of
Justice, Copyrighted Materials and the FOIA, FOIA Update, Fall 1983, at
pp. 3 to 5.
The EFOIAA amend FOIA to require Federal agencies to make certain
FOIA responses available to the public ``by computer telecommunications
or *** other electronic means,'' such as posting the FOIA response on
the Internet. The Department of Justice has advised Federal agencies
that when records are made available through electronic means such as
the Internet, the agency ``should guard against the possibility that
such extraordinarily wide dissemination of the record *** might be
regarded as copyright infringement.'' See U.S. Department of Justice,
Amendment Implementation Questions, FOIA Update, Winter 1997, at pp. 3
to 4.
FDA intends to make all redacted 510(k)s available through the
Internet, regardless of whether a FOIA request has been received. This
will make the information in those 510(k)s available to the public more
rapidly and without having to pay fees which may be assessed when FDA
responds to a FOIA request. FDA recognizes the need to avoid infringing
copyrights when providing redacted 510(k)s through the Internet, and
believes that it can provide appropriate protection of copyrighted
materials by distinguishing between two categories of materials: Those
whose copyright is owned by the applicant (e.g., an operating manual
for a device) and those whose copyright is owned by another person
(e.g., a copy of an article from a medical journal).
Under the proposed rule, copyrighted materials whose copyright is
owned by a person other than the applicant must be placed in a single
appendix, as required by proposed Sec. 807.90(e), and listed in a
bibliography, as required by proposed Sec. 807.87(k). These copyrighted
materials may not be included in any other portion of the 510(k). They
may be referred to at any point in the 510(k) by citing the appropriate
entry in the bibliography of copyrighted materials. FDA will not
release the appendix containing copyrighted materials as part of a
redacted 510(k) made available through FDA's Internet site, but would
release the bibliography of materials included in the appendix.
Copyrighted materials whose copyright is owned by the applicant may
be included, at the applicant's discretion, in any portion of a 510(k).
FDA would treat these materials in the same manner as any other
information submitted in a 510(k) and would include them in any
redacted 510(k) made available through FDA's Internet site. FDA also
intends to include a warning concerning the need to respect copyrights
with all copyrighted materials the agency provides through the
Internet. An applicant who is concerned about possible copyright
infringement by persons who obtain a redacted 510(k) from FDA's web
site may wish to clearly indicate when included material is copyrighted
or reformat the information prior to submitting a 510(k) to avoid
submitting copyrighted materials.
FDA recognizes that there is some uncertainty concerning the most
appropriate method of protecting copyrighted materials included in a
510(k). For that reason, FDA is requesting comments on both the
approach set forth in the proposed rule and on alternative approaches.
Possible alternatives include, but are not limited to, the following:
FDA could permit copyrighted materials from any source to be
included anywhere in the 510(k) and could include those materials with
the redacted 510(k) made available through the agency's Internet site,
while providing a clear and prominent warning to persons who download
the redacted 510(k) that they must avoid infringing copyrights and may
not make use of any copyrighted material unless such use would be a
``fair use.''
FDA could require explicit consent from each copyright holder,
permitting FDA to release those copyrighted materials through the
agency's Internet site as part of the redacted version of the 510(k).
An applicant would not be permitted to submit copyrighted material
without providing the required consent. If a copyright holder refuses
to provide the required consent, the applicant would be required to
reformat or summarize the relevant information from copyrighted
materials prior to submitting the 510(k) for clearance.
FDA could prohibit the inclusion of any copyrighted materials
whose copyright is owned by the applicant or by any person who prepared
the materials at the request of the applicant unless the applicant or
its agent consents to release of the material on FDA's Internet site.
Applicants who did not provide the required consent would have to
reformat the information to avoid the need to submit the copyrighted
material. Applicants would be permitted to submit copyrighted materials
from medical journals and other independent sources by including them
in a separate appendix and listing them in a bibliography.
FDA has also requested that the Department of Justice provide its
opinion concerning FDA's proposed approach. FDA will consider the
Department of Justice's response and any comments received on FDA's
proposed approach and alternative approaches in preparing a final rule.
B. Implementation and Enforcement
Under the proposed rule, FDA would not routinely review each
redacted 510(k) to ensure that the applicant has redacted all
confidential commercial information potentially eligible for
protection. In addition, except for cases of clearly abusive redactions
(e.g., a claim by a submitter that an entire file is exempt from
disclosure), FDA will rely on parties that request a 510(k) (through
FOIA or other channels) to raise any issue of excessive redaction. If
FDA learns that an applicant has inappropriately redacted information
not eligible for protection from disclosure under FOIA, FDA may require
the applicant to resubmit an appropriately redacted version, or may
release the inappropriately redacted information and pursue enforcement
action. This approach will enable FDA to provide information more
rapidly and focus more of its resources on device review.
FDA retains exclusive authority to make final determinations
concerning whether a redaction is permitted under FOIA and is not
delegating this authority to any person required to submit a redacted
510(k). Failure to provide a redacted version of a 510(k) in accordance
with a commitment to submit a redacted 510(k) made under Sec. 807.87(j)
would be a prohibited act under sections 301(p) and (q) of the act
(failure to provide any information required by section 510(k) and
failure or refusal to furnish information required under section 519 of
the act, records and reports on devices), 21 U.S.C. 331(p) and (q), and
may result in FDA enforcement action, including administrative civil
money penalties of up to $15,000 per violation (21 U.S.C. 333(f)). Some
of the resources currently devoted to identifying what information
should be protected from disclosure could be redirected, when
necessary, to compliance actions against submitters who do not follow
the new rule.
C. Relation to Requirement for a 510(k) Summary or 510(k) Statement
Section 513(i)(3) of the act requires a 510(k) applicant to include
an adequate summary of any information respecting safety and
effectiveness (``510(k) summary'') with each 510(k) submission or to
state that such information will be
[[Page 71351]]
made available upon request of any person (``510(k) statement'').
Applicants who choose to include a 510(k) statement in lieu of a 510(k)
summary must respond to written requests by an individual for a copy of
the 510(k), excluding patient identifiers and trade secret and
confidential commercial information, within 30 days of receipt of the
request. The information to be made available to a requestor is ``a
duplicate of the premarket notification submission including any
adverse safety and effectiveness information but excluding all patient
identifiers and trade secret or confidential commercial information, as
defined in Sec. 20.61'' (21 CFR 807.3(o)). Holders of 510(k)s may not
charge requestors for compiling and providing this information.
Noncompliance with the 510(k) statement is a prohibited act under
section 301(p) of the act.
The information which a 510(k) submitter must provide to requestors
when it elects to submit a 510(k) statement is the same information
that would be required to be submitted to FDA under this proposed
regulation, that is, a redacted 510(k). To avoid imposing redundant
burdens on 510(k) submitters, FDA will, at the submitter's option,
assume the burden of responding to requests for safety and
effectiveness information made under section 513(i) of the act.
Submitters who have submitted an appropriately redacted 510(k) to FDA
will be permitted under proposed Sec. 807.93(d) to refer all such
requests to FDA's Internet site (at http://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfpmn/search.cfm). Assuming the submitter has
provided an appropriately redacted 510(k) that meets FDA's
requirements, all the 510(k) submitter will be required to do to
fulfill its statutory obligation is to inform the requestor that the
requested information is available on FDA's Internet site; this
response to the requestor would have to be made within 10 days of the
request. FDA believes this approach will reduce costs submitters now
accrue when they submit a 510(k) statement and that requestors will
find it easier to obtain all such information from a single source.
A submitter who wishes to submit a 510(k) summary instead of a
510(k) statement will still be permitted to do so, but submission of a
510(k) summary will not relieve the submitter of its obligation under
this proposed rule to submit a redacted 510(k) to FDA. Section
807.93(a) has been amended to provide alternative 510(k) statements.
Section 807.93(a)(i) provides the statement to be submitted by a firm
that chooses to continue to reply directly to requests for safety and
effectiveness information; proposed Sec. 807.93(a)(ii) provides the
statement to be submitted by a firm that chooses to have FDA respond on
the firm's behalf to such requests.
A person who previously submitted a 510(k) statement, and thereby
committed to make available a redacted copy of the 510(k) upon the
request of any person, may revoke that statement by submitting a
redacted 510(k) to FDA. FDA will then assume the responsibility for
responding to requests for the redacted copy on behalf of that person.
Submitting a redacted 510(k) to FDA permits persons who have found it
burdensome to respond to such requests an opportunity to shift the
responsibility to FDA.
III. Request for Comments
Interested persons may, on or before March 22, 2000, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Comments regarding the information collection provisions
should be submitted by January 20, 2000. Two copies of any comments are
to be submitted, except that individuals may submit one 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 office
above between 9 a.m. and 4 p.m., Monday through Friday.
IV. 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, under the Regulatory Flexibility Act (5 U.S.C. 601-612),
and under the Unfunded Mandates Reform Act (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; and distributive impacts and equity). The Regulatory
Flexibility Act requires an analysis of regulatory options that would
minimize any significant impact of a rule on small entities unless an
agency certifies that a rule will not have a significant economic
impact on a substantial number of small entities. Section 202 of the
Unfunded Mandates Reform Act requires that agencies prepare an
assessment of anticipated costs and benefits before proposing any rule
that may result in an expenditure by State, local, and tribal
Governments, in the aggregate, or by the private sector, of $100
million in any one year (adjusted annually for inflation).
The agency believes that this proposed rule is consistent with the
regulatory philosophy and principles identified in Executive Order
12866. The proposed rule is limited to minimize its impact in two
significant ways: (1) There is no retrospective effect, because the
regulation will not apply to premarket notifications received by FDA
prior to the effective date of the regulation, and (2) it will not
apply to premarket notifications that were not found substantially
equivalent or which were withdrawn. FDA believes there will be no long-
term impact on most persons whose premarket notifications are found
substantially equivalent because the primary effect of the regulation
will affect only the timing of when a redacted version will be
required.
FDA currently bears the burden of redacting 35 percent of premarket
notifications requested under FOIA without any input from the
applicant, either because the applicant cannot be located or does not
respond to predisclosure notification. Therefore, this rule is expected
to shift to a great extent the resources needed to redact submissions
from FDA to the applicant who is in a much better position to redact
the 510(k). FDA estimates that 1,240 submissions are affected and that
for each submission it will take manufacturers 2 hours to comply. In
addition, submitters of the 4,423 premarket notifications that are
found substantially equivalent will spend up to 15 minutes to prepare
and submit a statement of compliance with this rule to FDA. Using
hourly earnings of $35, FDA estimates the total annual cost of
compliance with this proposed rule is approximately $125,500. The
hourly earnings are derived from the Statistical Abstract of the United
States 1997, Table 672 median annual earnings in 1995 for men in a
professional specialty, adjusted for fringe benefits and pay increases
(30 percent and 20 percent, respectively). Because these costs are
based on no more than 2.25 hours per submission and are spread over
many submitters, this rule will not have a significant economic impact
on small entities.
FDA further believes that by preparing the redacted version
earlier, while the expert team that contributed
[[Page 71352]]
to the development of the 510(k) is available and engaged, there may be
some long-term savings when compared with the costs of delayed
redaction inherent in the current approach.
This rule is not a significant regulatory action as defined by the
Executive Order, and is not subject to review under the Executive
Order. This rule does not impose any mandates on State, local, or
tribal governments, nor is it a significant regulatory action under the
Unfunded Mandates Reform Act. Furthermore, the agency certifies that
this rule will not have a significant economic impact on a substantial
number of small entities. Therefore, under the Regulatory Flexibility
Act, no further regulatory flexibility analysis is required.
VI. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520). The title, description, and respondent
description of the information collection provisions are shown below
with an estimate of the annual reporting 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: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have a 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: Addition of Written Commitment to Submit, and Submission of,
a Redacted Premarket Notification upon FDA's Finding of Substantial
Equivalency
Description: The statutory authority for this proposed regulation
includes: (1) The authority to require premarket notification
(generally referred to as 510(k)) ( 21 U.S.C. 360(k)); (2) The Freedom
of Information Act (5 U.S.C. 552) (FOIA) because a premarket
notification that has been cleared by FDA (found to be substantially
equivalent) is subject to public disclosure under 5 U.S.C. 552, which
requires Federal agencies to release all agency records, including
materials obtained by the agency, except to the extent a FOIA exemption
applies; (3) FOIA sections 552(b) and (c), and specifically 552(b)(4),
permit withholding of certain information from public disclosure,
including ``trade secrets and commercial or financial information
obtained from a person and privileged or confidential;'' and (4)
section 513(i)(3) of the act requires an adequate summary of
information respecting safety and effectiveness to be provided by the
submitter of a 510(k) that has been cleared by FDA. In addition, the
act requires withholding of trade secret information from the public
(21 U.S.C. 331(j)), and the Trade Secrets Act also prohibits disclosure
of trade secrets and confidential commercial information unless
specifically authorized by law, 18 U.S.C. 1905.
These proposed reporting requirements are intended to provide
applicants with an improved opportunity to protect nonpublic
information contained in their premarket notifications while
facilitating the release of information to which the public is
entitled. The proposed rule would preserve scarce FDA resources because
it proposes to eliminate the need for FDA to routinely redact any
510(k) submitted after the effective date except to the extent
challenges are raised to the redactions made by the applicant or in
other cases where the agency finds that the applicant has not provided
an appropriately redacted 510(k). The proposed rule also would preserve
FDA resources by eliminating the need to routinely provide individual
predisclosure notification and followup to 510(k) holders when a 510(k)
is requested. The proposed written commitment to submit a redacted
510(k) is intended to provide FDA with assurance that the applicant
agrees to provide the redacted 510(k) within 30 days of FDA issuing its
substantial equivalence order.
The proposed rule would require the premarket submission to include
a written commitment from the submitter agreeing to provide a redacted
version of their 510(k) (from which those portions that contain ``trade
secrets and commercial or financial information obtained from a person
and privileged or confidential or protected personal privacy
information'' are deleted) within 30 days of FDA issuing its order of
substantial equivalence, together with a redacted copy of the 510(k).
Description of Respondents: Businesses or other for profit
organizations.
FDA estimates the burden of this collection of information as follows:
Table 2.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
807.87(j) and 807.91 4,423 1 4,423 0.25 1,106
807.95(f) 3,675 1 3,675 2.00 7,350
Total Hours 2.25 8,456
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs or capital costs associated with this collection of
information.
Several steps were performed by FDA to derive the burden hour
estimates. FDA estimated the number of respondents by first taking the
number of 510(k)s filed and cleared during FY 1998 (4,656) and reducing
those numbers by roughly 5 percent because the number of 510(k)s filed
in the past few years has been decreasing at approximately that rate
(6,434 510(k)s were received during FY 94, compared with 4,656 during
FY 98; 510(k) receipts have decreased each year since FY 94). The
projected number of 510(k)s filed provides the number of respondents
(approximately 4,423) affected by proposed Sec. 807.87(j).
To determine the number of respondents affected by proposed
Sec. 807.95(f), FDA estimated the number of 510(k)s expected to be
cleared (approximately 3,675), using the methodology previously
described.
[[Page 71353]]
FDA then estimated the amount of hours per response. The estimate
for proposed Sec. 807.87(j) is based on FDA's professional judgment.
The estimate for proposed Sec. 807.95(f) is based on FDA's direct
experience in redacting 510(k)s. FDA then multiplied the total annual
responses by the hours per response to obtain the total hours. The
hours per response includes the amount of time to add the statement to
the premarket submission and to review and redact the premarket
submission. There are no capital or operating and maintenance costs
associated with this information collection.
In compliance with section 3507(d) of the PRA (44 U.S.C. 3507(d)),
FDA has submitted the information collection provisions of this
proposed rule to OMB for review. Interested persons are requested to
send comments regarding information collection by January 20, 2000, to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
List of Subjects in 21 CFR Part 807
Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 807 be amended as follows:
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTS OF DEVICES
1. The authority citation for 21 CFR part 807 continues to read as
follows:
Authority: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j,
371, 374.
2. Section 807.87 is amended by redesignating paragraphs (j), (k),
and (l), as paragraphs (l), (m), and (n); and by adding new paragraphs
(j) and (k) to read as follows:
Sec. 807.87 Information required in a premarket notification
submission.
* * * * *
(j) A written commitment, as described in Sec. 807.91 that the
submitter will provide to FDA, no later than 30 days after the date of
the FDA order declaring the device to be substantially equivalent under
Sec. 807.100(a)(1), a copy of the premarket notification submission,
with all information that is exempt from public disclosure in
accordance with part 20 of this chapter redacted in accordance with
Sec. 807.95(f).
(k) A bibliography of all copyrighted materials included in the
premarket notification submission.
* * * * *
3. Section 807.90 is amended by adding paragraph (f) to read as
follows:
Sec. 807.90 Format of a premarket notification submission.
* * * * *
(f) Include any copies of copyrighted materials in a single
appendix, which shall be the final section of the premarket
notification. Copyrighted materials whose copyright is not owned by the
applicant shall not be included in any other section of the premarket
notification.
4. Section 807.91 is added to subpart E to read as follows:
Sec. 807.91 Commitment to submit a redacted 510(k).
(a) A statement committing to submit a redacted 510(k) shall state
as follows:
I certify that, in my capacity as the (position held in company
by person required to submit the premarket notification, preferably
the official correspondent in the firm) of (company name), I will
submit to FDA, no later than 30 days after the date of an FDA order
under Sec. 807.100(a)(1) declaring this device to be substantially
equivalent, a redacted copy of the entire premarket notification as
required by Sec. 807.95(f).
(b) The statement in paragraph (a) of this section should be signed
by the certifier, made on a separate page of the premarket notification
submission, and clearly identified as ``Commitment to Submit a Redacted
510(k).''
5. Section 807.93 is amended by revising paragraph (a) and by
adding paragraphs (d) and (e) to read as follows:
Sec. 807.93 Content and format of a 510(k) statement.
(a)(1) A 510(k) statement submitted as part of a premarket
notification shall state as follows (choose one):
(i) Option 1--For firms that will directly respond to all requests
for information:
I certify that, in my capacity as (the position held in company
by person required to submit the premarket notification, preferably
the official correspondent in the firm), of (company name), I will
make available all information included in this premarket
notification on safety and effectiveness within 30 days of request
by any person if the device described in the premarket notification
submission is determined to be substantially equivalent. The
information I agree to make available will be a duplicate of the
premarket notification submission, including any adverse safety and
effectiveness information, but excluding all patient identifiers,
and trade secret and confidential commercial information, as defined
in Sec. 20.61.
(ii) Option 2--For firms that choose to have FDA respond on the
firm's behalf to all requests for information:
I certify that, in my capacity as (the position held in company
by person required to submit the premarket notification, preferably
the official correspondent in the firm), of (company name), I will
refer all requests for information included in this premarket
notification to FDA's Internet site (http://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfpmn/search.cfm) within 10 days of request by
any person if the device described in the premarket notification
submission is determined to be substantially equivalent.
(2) The statement in paragraph (a)(1)(i) of this section should be
signed by the certifier, made on a separate page of the premarket
notification submission, and clearly identified as ``510(k)
statement.''
(3) The statement in paragraph (a)(1)(ii) of this section should be
signed by the certifier, made on a separate page of the premarket
notification submission, and clearly identified as ``Commitment to
Refer 510(k) Requests to FDA.''
* * * * *
(d) At the option of a 510(k) submitter who has elected to submit
the statement provided in paragraph (a)(1)(ii) of this section and who
has submitted an appropriately redacted 510(k) to FDA under
Sec. 807.95(f), all requests received by the submitter for information
included in paragraph (a) of this section may be satisfied by referring
the requestor to FDA's Internet cite.
(e) A previously submitted 510(k) statement may be revoked any
time, subject to the following requirements:
(1) A revocation of a 510(k) statement is made by submitting a copy
of all information submitted with, or incorporated by reference in, the
premarket submission, from which information that is exempt from public
disclosure under part 20 of this chapter has been redacted.
(2) Redactions shall be made as specified by Sec. 807.95(f).
(3) The redacted copy is to be sent to FDA's Center that reviewed
the 510(k) at the appropriate address provided in Sec. 807.95(f)(4).
(4) A revocation of a 510(k) statement becomes effective 30 days
after it has been submitted to FDA. The submitter must respond to all
requests for information received prior to the effective date.
6. Section 807.95 is amended by adding paragraph (f) to read as
follows:
Sec. 807.95 Confidentiality of information.
* * * * *
(f)(1) Not later than 30 days after the date of the FDA order
issued under Sec. 807.100(a)(1) declaring a device to be
[[Page 71354]]
substantially equivalent, the submitter shall send to FDA a copy of all
information submitted with, or incorporated by reference in, a
premarket submission, from which information that is exempt from public
disclosure under part 20 of this chapter has been redacted in one of
the following two ways:
(i) The information exempt from disclosure has been physically
obscured so as to render it illegible, e.g., by covering the text or
figure with black ink.
(ii) The information exempt from disclosure has been omitted. In
such cases, the extent of the deletions shall be described, e.g.,
``Pages 12 through 15 have been deleted.''
(2) Whenever copyrighted materials are obscured or omitted, a
reference to the bibliographic entry identifying the material under
Sec. 807.87(k) shall be included at the point where the materials
originally appeared in the submission.
(3) The redacted copy may be submitted on a disk as a portable
document format (.pdf) file.
(4) The redacted copy is to be sent to the center that reviewed the
510(k) at the appropriate address: Food and Drug Administration, Center
for Devices and Radiological Health (HFZ-82), 2098 Gaither Rd.,
Rockville, MD 20850, or Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-99), 11401 Rockville Pike,
Rockville, MD 20852.
Dated: December 10, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-33003 Filed 12-20-99; 8:45 am]
BILLING CODE 4160-01-F
