[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Draft Guidance on Resolving Scientific Disputes Concerning the 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availability of the draft guidance entitled ``Resolving Scientific 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written requests for single copies on a ``3.5'' diskette of the draft 
guidance document entitled ``Resolving Scientific Disputes Concerning 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]
BILLING CODE 4160-01-F