Premarket Notification; Requirement for Redacted Version of Substantially-Equivalent Premarket Notification

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