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									                         Federal Register / Vol. 61, No. 231 / Friday, November 29, 1996 / Notices                                 60713

  Dated: October 24, 1996.                       generally indicated for long-term            showing that there is a genuine and
Joseph A. Levitt,                                cardiac pacing. Generally accepted           substantial issue of material fact for
Deputy Director for Regulations Policy, Center   indications for long-term pacing             resolution through administrative
for Devices and Radiological Health.             include, but are not limited to, sick        review. After reviewing the petition,
[FR Doc. 96–30443 Filed 11–27–96; 8:45 am]       sinus syndrome; chronic sinus                FDA will decide whether to grant or
BILLING CODE 4160–01–F                           arrhythmias; including sinus                 deny the petition and will publish a
                                                 bradycardia; sinus arrest; and sinoatrial    notice of its decision in the Federal
                                                 (SA) block; second- and third-degree         Register. If FDA grants the petition, the
[Docket No. 96M–0451]                            atrioventricular (AV) block;                 notice will state the issue to be
                                                 bradycardia-tachycardia syndrome; and        reviewed, the form of the review to be
Cardiac Pacemakers, Inc.; Premarket
                                                 carotid sinus syndrome. Patients who         used, the persons who may participate
Approval of VIGOR® DR Pacemaker
                                                 demonstrate hemodynamic                      in the review, the time and place where
System/VIGOR® SR Pacemaker                       improvement from AV synchrony
System                                                                                        the review will occur, and other details.
                                                 should be considered for one of the            Petitioners may, at any time on or
AGENCY:   Food and Drug Administration,          dual-chamber or atrial pacing modes.         before December 30, 1996, file with the
HHS.                                             Dual-chamber modes are specifically          Dockets Management Branch (address
ACTION:   Notice.                                indicated for treatment of conduction        above) two copies of each petition and
                                                 disorders that require restoration of rate   supporting data and information,
SUMMARY: The Food and Drug                       and AV synchrony, including varying          identified with the name of the device
Administration (FDA) is announcing its           degrees of AV block; low cardiac output      and the docket number found in
approval of the application by Cardiac           or congestive heart failure related to       brackets in the heading of this
Pacemakers, Inc., St. Paul, MN, for              bradycardia; and certain                     document. Received petitions may be
premarket approval, under the Federal            tachyarrhythmias. The adaptive-rate          seen in the office above between 9 a.m.
Food, Drug, and Cosmetic Act (the act),          pacing modes of the VIGOR® DR and            and 4 p.m., Monday through Friday.
of the VIGOR® DR Pacemaker System/               VIGOR® SR pulse generators are                 This notice is issued under the
VIGOR® SR Pacemaker System. After                indicated for patients exhibiting            Federal Food, Drug, and Cosmetic Act
reviewing the recommendation of the              chronotropic incompetence and who            (secs. 515(d), 520(h) (21 U.S.C. 360e(d),
Circulatory System Devices Panel,                would benefit by increased pacing rates      360j(h))) and under authority delegated
FDA’s Center for Devices and                     concurrent with physical activity.           to the Commissioner of Food and Drugs
Radiological Health (CDRH) notified the             On May 9, 1995, the Circulatory           (21 CFR 5.10) and redelegated to the
applicant, by letter on June 21, 1995, of        System Devices Panel of the Medical          Director, Center for Devices and
the approval of the application.                 Devices Advisory Committee, an FDA           Radiological Health (21 CFR 5.53).
DATES: Petitions for administrative              advisory committee, reviewed and
                                                                                                Dated: November 7, 1996.
review by December 30, 1996.                     recommended approval of the
                                                 application. On June 21, 1995, CDRH          Joseph A. Levitt,
ADDRESSES: Written requests for copies
                                                 approved the application by a letter to      Deputy Director for Regulations Policy, Center
of the summary of safety and                                                                  for Devices and Radiological Health.
effectiveness data and petitions for             the applicant from the Director of the
                                                 Office of Device Evaluation, CDRH.           [FR Doc. 96–30508 Filed 11–27–96; 8:45 am]
administrative review, to the Dockets
                                                    A summary of the safety and               BILLING CODE 4160–01–F
Management Branch (HFA–305), Food
                                                 effectiveness data on which CDRH
and Drug Administration, 12420
                                                 based its approval is on file in the
Parklawn Dr., rm. 1–23, Rockville, MD                                                         [Docket No. 96N–0443]
                                                 Dockets Management Branch (address
                                                 above) and is available from that office     Review of Clinical Safety Data in
FOR FURTHER INFORMATION CONTACT:                 upon written request. Requests should
Carole C. Carey, Center for Devices and                                                       Marketing Applications; Notice of
                                                 be identified with the name of the           Public Workshop
Radiological Health (HFZ–450), Food              device and the docket number found in
and Drug Administration, 9200                    brackets in the heading of this              AGENCY:   Food and Drug Administration,
Corporate Blvd., Rockville, MD 20850,            document.                                    HHS.
                                                 Opportunity for Administrative Review        ACTION:   Notice.
September 30, 1994, Cardiac                         Section 515(d)(3) of the act (21 U.S.C.   SUMMARY:  The Food and Drug
Pacemakers, Inc., St. Paul, MN 55112,            360e(d)(3)) authorizes any interested        Administration (FDA) is announcing a
submitted to CDRH an application for             person to petition, under section 515(g)     public workshop, as part of its ‘‘good
premarket approval of the following:             of the act, for administrative review of     review practices’’ (GRP’s), to provide an
VIGOR® DR (dual chamber) Model                   CDRH’s decision to approve this              opportunity for input from the
1230/1235 Pulse Generators, VIGOR®               application. A petitioner may request        pharmaceutical industry, academia, and
SR (single chamber) Model 1130/1135              either a formal hearing under 21 CFR         the public on the principles and
Pulse Generators, and the Model 2075             part 12 of FDA’s administrative              methods being used by FDA in the
Software Module to be used with                  practices and procedures regulations or      review of clinical safety data in new
commercially available CPI® Model                a review of the application and CDRH’s       drug product applications. Information
2035 Handheld Programmer and Model               action by an independent advisory            and ideas generated at the workshop
6575 or 6577 Telemetry Wand; Model               committee of experts. A petition is to be    will be used to develop a guidance for
6942 Bidirectional Torque Wrench;                in the form of a petition for                reviewers who participate in the
Model 6562 Horseshoe Magnet; Model               reconsideration under 21 CFR 10.33(b).       agency’s clinical review process. A
6580 Electrogram Cable; Model 6589               A petitioner shall identify the form of      working draft of that guidance, ‘‘Draft
Printer Paper; and commercially                  review requested (hearing or                 Guidance for Reviewers: Conducting a
available pacemaker leads and                    independent advisory committee) and          Clinical Safety Review of a New Product
accessories that are compatible with the         shall submit with the petition               Application and Preparing a Report on
pulse generators. The devices are                supporting data and information              the Review,’’ along with a tentative
60714               Federal Register / Vol. 61, No. 231 / Friday, November 29, 1996 / Notices

workshop agenda, will be available 3          the quality and efficiency of the clinical     Dated: November 21, 1996.
weeks before the workshop.                    reviews of new product applications.         William K. Hubbard,
DATES: The public workshop will be               To manage this large initiative, the      Associate Commissioner for Policy
held on Wednesday, December 18, 1996,                                                      Coordination.
                                              agency developed a multitrack plan to
from 8:30 a.m. to 5 p.m. Because space        be implemented in stages. Tasks              [FR Doc. 96–30509 Filed 11–27–96; 8:45 am]
is limited, interested parties are            currently under development include:         BILLING CODE 4160–01–F
encouraged to register as soon as             Defining the critical elements of the
possible, or at least by December 13,         clinical review; designing a process for
1996. There is no registration fee for the                                                 Health Resources and Services
                                              feedback, evaluation, and evolution in       Administration
workshop. The administrative docket           review practices and procedures;
will remain open until January 31, 1997,      developing a data base on regulatory
to receive written comments, data,                                                         Agency Information Collection
                                              policy for clinical review; and defining     Activities: Submission for OMB
information, or views on the draft
                                              good data handling practices.                Review; Comment Request
guidance or the workshop.
                                                 The December 18, 1996, workshop is          Periodically, the Health Resources
ADDRESSES: The public workshop will
be held at the DoubleTree Hotel, 1750         a part of an effort to define the critical   and Services Administration (HRSA)
Rockville Pike, Rockville, MD. Persons        elements of the clinical safety review       publishes abstracts of information
interested in attending can register by       process and develop a guidance for           collection requests under review by the
faxing their name and title, organization     reviewers that describes those elements      Office of Management and Budget, in
name, if any, address, telephone and fax      and sets institutional expectations for      compliance with the Paperwork
numbers to Paul A. David at FAX 301–          each level of review. The guidance           Reduction Act of 1995 (44 U.S.C.
594–2859.                                     being developed is intended for use by       Chapter 35). To request a copy of the
   Three weeks prior to the workshop, a       agency officers and other clinical           clearance requests submitted to OMB for
copy of the draft guidance for reviewers,     reviewers during the review of new drug      review, call the HRSA Reports
along with a tentative workshop agenda,       product applications. The draft              Clearance Office on (301)–443–1129.
will be available through CDER’s Fax-         guidance will be discussed at the              The following request has been
on-Demand, 301–827–0577 or 800–342–           workshop.                                    submitted to the Office of Management
2722, under the index, document no.                                                        and Budget for review under the
                                                 The primary goal of the workshop is
0506. Information on the workshop and                                                      Paperwork Reduction Act of 1995:
                                              to provide an opportunity for input from
registration also will be available via the   industry, academia, and the public on        Uncompensated Services Reporting and
Internet using the World Wide Web             the principles and methods for the           Recordkeeping—42 CFR 124, Subpart F
(WWW). To connect to the CDER home            review of clinical safety data in new        (OMB No. 0915–0077)—Extension and
page, type http://www.fda.gov/cder and                                                     Revision
                                              drug applications. To encourage the
go to the ‘‘What’s Happening’’ section.
                                              exchange of ideas and comments, the             Titles VI and XVI of the PHS Act,
A transcript of the workshop will be
available from the Freedom of                 day-long workshop has been divided           commonly known as the Hill-Burton
Information Office (HFI–35), Food and         into the following four major sessions:      Act, provide for government grants and
Drug Administration, 5600 Fishers             (1) Characterizing the exposed               loans for construction or renovation of
Lane, Rockville, MD 20857,                    population, establishing the common          health care facilities. As a condition of
approximately 15 business days after          adverse events profile, establishing the     receiving this construction assistance,
the workshop at a cost of 10 cents per        serious adverse events profile, and          facilities are required to provide a
page.                                         integrating important safety findings        ‘‘reasonable volume’’ of services to
   Written comments on the draft              using the review of systems approach.        persons unable to pay. Facilities are also
reviewer guidance or on the workshop          Each session will include a panel            required to provide assurances
can be submitted until January 31, 1997,      discussion and a period at the end for       periodically that the required level of
to the Dockets Management Branch              public comment.                              uncompensated care is being provided,
(HFA–305), 12420 Parklawn Dr., rm. 1–                                                      and to follow certain notification and
                                                 The agency hopes to answer the            recordkeeping procedures. These
23, Rockville, MD 20857. Two copies of        following questions during the
comments are to be submitted, except                                                       requirements are referred to as the
                                              workshop: (1) What approaches to safety      uncompensated services assurance.
that individuals may submit one copy.         data review could speed the overall             Certain types of facilities can apply
Comments are to be identified with the        review process? (2) What steps could be      for one of four compliance alternatives
docket number found in brackets in the        taken to standardize the presentation of     which reduce the reporting,
heading of this document. Received            safety review data? (3) Are there review     recordkeeping, and notification
comments may be viewed at the Dockets
                                              or review-related issues that are            requirements. A new compliance
Management Branch between 9 a.m. and
                                              especially troublesome for those             alternative has been added to this
4 p.m., Monday through Friday.
                                              submitting safety data? (4) Do some          clearance package.
FOR FURTHER INFORMATION CONTACT: Paul         approaches to data presentation make            The regulations contain provision for
A. David, Food and Drug                       the reviewer’s job easier or more            reporting to the government the amount
Administration, Center for Drug               difficult?                                   of free care provided, as well as
Evaluation and Research (HFD–120),                                                         provisions for following certain
5600 Fishers Lane, Rockville, MD                 As it proceeds with the finalization of
                                                                                           notification and recordkeeping
20857, 301–594–5530.                          the guidance for reviewers, the agency
                                                                                           procedures. The regulations also define
                                              will consider carefully all data and         the procedures for applying for
1994, FDA launched a major initiative         information presented at the workshop        certification (and annual recertification)
to develop and implement GRP’s. The           and submitted in writing on the              under a compliance alternative. All of
goal of the GRP’s initiative is to identify   guidance and workshop                        these regulations are included in this
and implement methods for improving                                                        clearance request. The Uncompensated

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