[Federal Register Volume 64, Number 80 (Tuesday, April 27, 1999)]
[Notices]
[Pages 22617-22619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10446]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-0239]
Draft Guidance on Resolving Scientific Disputes Concerning the
Regulation of Medical Devices; Administrative Procedures on Use of the
Medical Devices Dispute Resolution Panel; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Resolving Scientific
Disputes Concerning the Regulation of Medical Devices: An
Administrative Procedures Guide to Use of the Medical Devices Dispute
Resolution Panel.'' Section 404 of the Food and Drug Administration
Modernization Act of 1997 (FDAMA) directed FDA to ensure that it has
effective processes to resolve the scientific disputes that
occasionally arise between FDA and the regulated industry, including a
review by an appropriate panel of experts to advise the agency on
issues upon which industry and FDA professionals differ. This guidance
is neither final nor is it in effect at this time.
DATES: Written comments concerning this guidance must be received by
July 26, 1999. Written comments concerning the information collection
requirements must be received by June 28, 1999.
ADDRESSES: Written comments concerning this guidance must be submitted
to the Dockets Management Branch, (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Comments should be identified with the docket number found in brackets
in the heading of this document. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance. Submit
written requests for single copies on a ``3.5'' diskette of the draft
guidance document entitled ``Resolving Scientific Disputes Concerning
the Regulation of Medical Devices: An Administrative Procedures Guide
to Use of the Medical Devices Dispute Resolution Panel'' to the
Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your request, or fax your
request to 301-443-8818. Submit written comments on the collection of
information requirements to the Dockets Management Branch (address
above). Comments should be identified with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: James G. Norman, Center for Devices
and Radiological Health (HFZ-2), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-4690.
SUPPLEMENTARY INFORMATION:
I. Background
FDA provides various mechanisms by which the device industry can
obtain reconsideration of FDA decisions and actions under the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.), the
Administrative Procedure Act (5 U.S.C. 551 et seq.), and agency
regulations. These processes are summarized in a guidance document
entitled ``Medical Device Appeals and Complaints Guidance on Dispute
Resolutions,'' which is available from the CDRH web site at ``http://
www.fda.gov/cdrh/resolvingdisputes''.
Section 404 of FDAMA added to these various mechanisms by
directing FDA to ensure it has effective processes by which a medical
device ``sponsor, applicant, or manufacturer'' can obtain independent
review of a ``scientific controversy'' between that person and FDA. In
the Federal Register of June 16, 1998 (63 FR 32733 and 32772), FDA
published a direct final rule and a companion proposed rule amending
Sec. 10.75 (21 CFR 10.75) to add another method of resolving scientific
controversies. This amendment stated that sponsors, applicants, or
manufacturers of drugs (including human drugs, animal drugs, and human
biologics), or devices may request review of scientific controversies
by an appropriate scientific advisory panel or advisory committee.
(Hereafter in this document, the term advisory committee includes
scientific advisory panels.) By this amendment, FDA clarified that
sponsors, applicants, and manufacturers of drugs, biologics, and
devices are not limited solely to requesting internal supervisory
review, but also have the right to request review of scientific
controversies by appropriate advisory committees. FDA believes that in
appropriate circumstances, advisory committees can provide the agency
with useful insight and advice about the resolution of scientific
controversies.
FDA initially used the direct final rule because it believed the
amendment to Sec. 10.75 was noncontroversial and in accord with FDAMA.
In accordance with FDA's procedures for direct final rulemaking, the
direct final rule stated that if FDA received no significant adverse
comments, the direct final rule would go into effect on October 29,
1998. The direct final rule stated further that if FDA received any
significant adverse comments, it would withdraw the direct final rule
and consider all comments received on the companion proposed rule in
the development of a final rule using the usual notice and comment
rulemaking procedures. The comment period for the companion proposed
rule ended on August 31, 1998. FDA received significant adverse
comments in response to the direct final rule and the companion
proposed rule. Therefore, in the Federal Register of September 23,
1998 (63 FR 50757), FDA withdrew the direct final rule.
Significant adverse comments asserted that the amendment to
Sec. 10.75 failed to provide a procedure that sponsors, applicants, and
manufacturers could follow to request reviews under section 404 of
FDAMA (section 404 reviews). The comments suggested that the regulation
called for by section 404 of FDAMA should contain information such as
the process for selecting members of an advisory committee convened to
conduct a section 404 review, the timeframes for conducting the
reviews, the standards for granting or denying a section 404 review,
and the weight to be given to advisory committee recommendations.
In a final rule issued in the Federal Register on November 18,
1998 (63 FR 63978), FDA acknowledged the usefulness of much of this
kind of information, but concluded that it should not be included in
Sec. 10.75. Because of the significant differences among FDA centers in
applicable statutory provisions, existing appeal and dispute resolution
mechanisms, and approaches to advisory committee management, FDA is
adopting a center-based approach to the implementation of section 404
of FDAMA. Each affected center is responsible for developing and
administering its own processes for handling requests for section 404
reviews and is issuing a guidance document containing specific
information of the type suggested by the comments. The substantive
differences in the programs in the affected centers, and the different
matters that could be
[[Page 22618]]
the subject of a request for advisory committee review, preclude
inclusion of this type of information in Sec. 10.75.
The final rule amended Sec. 10.75 by redesignating paragraph (b)
as paragraph (b)(1) and by adding paragraph (b)(2) to read as follows:
A sponsor, applicant, or manufacturer of a drug or device
regulated under the act or the Public Health Service Act (42 U.S.C.
262), may request review of a scientific controversy by an
appropriate scientific advisory panel as described in section 505(n)
of the act, or an advisory committee as described in section
515(g)(2)(B) of the act. The reason(s) for any denial of a request
for such review shall be briefly set forth in writing to the
requester. Persons who receive a center denial of their request
under this section may submit a request for review of the denial.
The request should be sent to the Chief Mediator and Ombudsman.
To implement the new provision and to comply with Sec. 10.75, as
amended, the Center for Devices and Radiological Health has created the
Medical Devices Dispute Resolution Panel, which will operate under
FDA's Medical Devices Advisory Committee. In addition to serving as a
useful forum in which scientific disputes in general can be aired, the
Medical Devices Dispute Resolution Panel will implement four provisions
of the Federal Food, Drug, and Cosmetic Act:
(1) Section 514(b)(5)(B) of the act requires the establishment of
an advisory committee to take referrals of any matter concerning the
establishment, amendment, or revocation of a performance standard which
requires the exercise of scientific judgment.
(2) Section 515(g)(2)(B) of the act requires the establishment of
an advisory committee to take referrals of petitions for review of:
(a) the approval, denial, or withdrawal of approval of a premarket
approval application, or
(b) the revocation of an approved product development protocol
(PDP), a declaration that an approved PDP has not been completed, or a
revocation of an approved Notice of Completion that permitted marketing
of a device developed under a PDP.
(3) Section 522(b) of the act, which was added by section 212 of
FDAMA, requires a process to resolve any disputes concerning the need
for FDA to order a manufacturer to conduct postmarket surveillance for
more than 36 months.
(4) Section 562 of the act requires FDA to provide a procedure for
review of all scientific disputes regarding the regulation of medical
devices, including review by an appropriate scientific advisory panel,
but only to the extent that other provisions of the act or FDA
regulations do not already provide a right of review. FDA believes its
current procedures already provide methods to obtain review of most, if
not all, scientific disputes. The establishment of the Dispute
Resolution Panel provides an additional, more focused, procedure for
the timely review of scientific disputes.
This draft guidance document sets forth guidelines that will
govern the operation of the Medical Devices Dispute Resolution Panel.
Those guidelines include the appointment of a CDRH Ombudsman, who will
be designated to receive, review, and make recommendations with respect
to requests for review by the resolution panel. CDRH intends to ensure
that a center ombudsman is in place before final guidance goes into
effect.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on ``Resolving Scientific Disputes Concerning the Regulation
of Medical Devices: An Administrative Procedures Guide to Use of the
Medical Devices Dispute Resolution Panel.'' It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the applicable statute, regulations, or both.
The agency has adopted Good Guidance Practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This draft guidance document is issued as a Level 1 guidance,
consistent with GGP's.
III. Electronic Access
In order to receive ``Resolving Scientific Disputes Concerning the
Regulation of Medical Devices: An Administrative Procedures Guide to
Use of the Medical Devices Dispute Resolution Panel'' via your fax
machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or
301-827-0111 from a touch-tone telephone. At the first voice prompt
press 1 to access DSMA Facts, at second voice prompt press 2, and then
enter the document number 1121 followed by the pound sign (#). Then
follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so using the World Wide Web (WWW). CDRH maintains an entry on the WWW
for easy access to information including text, graphics, and files that
may be downloaded to a personal computer with access to the WWW.
Updated on a regular basis, the CDRH home page includes ``Resolving
Scientific Disputes Concerning the Regulation of Medical Devices: An
Administrative Procedures Guide to Use of the Medical Devices Dispute
Resolution Panel,'' device safety alerts, Federal Register reprints,
information on pre-market submissions (including lists of approved
applications and manufacturers' addresses), small manufacturers'
assistance, information on video conferencing and electronic
submissions, mammography matters, and other device-oriented
information. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''. ``Resolving Scientific Disputes Concerning the
Regulation of Medical Devices: An Administrative Procedures Guide to
Use of the Medical Devices Dispute Resolution Panel'' will be available
at ``http://www.fda.gov/cdrh/resolvingdisputes''.
IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506 (c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth below.
With respect to the following 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 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.
[[Page 22619]]
Title: Request for Resolution of Scientific Disputes Concerning the
Regulation of Medical Devices
Description: Section 404 of the Food and Drug Administration
Modernization Act of 1997 (FDAMA) is intended to ensure that FDA has
effective processes to resolve the scientific disputes that
occasionally arise between FDA and the regulated industry. Section 404
added new section 562 of the act which requires FDA to establish, by
regulation, a procedure under which a person who is a sponsor,
applicant, or manufacturer may request a review of a scientific
controversy, when no other provision of the act or regulation provides
such review.
In a final rule issued in the Federal Register on November 18,
1998 (63 FR 63978), FDA amended 21 CFR 10.75 to reflect the provisions
of FDAMA. Each affected FDA center is responsible for developing and
administering its own processes for handling requests for section 404
reviews and is issuing a guidance document containing specific
information of the type suggested by the comments. The draft guidance
document outlines the requirements for persons who are sponsors,
applicants, or manufacturers of medical devices and who wish to file a
request for a review of a scientific dispute by the panel as set out in
the guidance. Persons filing a request for review should provide a CDRH
ombudsman with a concise summary of the scientific issue in dispute,
including a summary of the particular FDA action or decision to which
the requesting party objects, any prior advisory panel action and the
results of all efforts that have been made to resolve the dispute, and
a clear articulated summary of the arguments and relevant data and
information. They may also provide material outside the official
administrative record and not in the possession of FDA at the time the
decision or action in dispute was made if it has a significant bearing
on the issue or related public health considerations. The information
that is collected will form the basis for resolving the dispute between
the requester and FDA.
The likely respondents to this collection of information are
medical device sponsors, applicants, or manufacturers who have a
scientific dispute with FDA and who request a review of the matter by
the Medical Devices Dispute Resolution Panel.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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6............ 1 6 20 120
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\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
The Medical Devices Dispute Resolution Panel represents a new
process for resolving scientific disputes. In arriving at the estimates
in Table 1 of this document for the burden imposed in connection with a
request for review by the Medical Devices Dispute Resolution Panel, FDA
considered the number and substance of similar appeals of various types
made to FDA in recent years, knowledge of similar submissions and
discussions with manufacturers.
V. Comments
Interested persons may, on or before July 26, 1999, submit to
Dockets Management Branch (address above) written comments regarding
this draft guidance. 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. Written comments concerning the information collection
requirements must be received by the Dockets Management Branch by June
28, 1999. The guidance document and received comments may be seen in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: March 30, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-10446 Filed 4-26-99; 8:45 am]
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