[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