[Federal Register Volume 61, Number 122 (Monday, June 24, 1996)]
[Notices]
[Pages 32443-32446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15942]



-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces forthcoming meetings of public advisory 
committees of the Food and Drug Administration (FDA). This notice also 
summarizes the procedures for the meetings and methods by which 
interested persons may participate in open public hearings before FDA's 
advisory committees.

    FDA has established an Advisory Committee Information Hotline (the 
hotline) using a voice-mail telephone system. The hotline provides the 
public with access to the most current information on FDA advisory 
committee meetings. The advisory committee hotline, which will 
disseminate current information and information updates, can be 
accessed by dialing 1-800-741-8138 or 301-443-0572. Each advisory 
committee is assigned a 5-digit number. This 5-digit number will appear 
in each individual notice of meeting. The hotline will enable the 
public to obtain information about a particular advisory committee by 
using the committee's 5-digit number. Information in the hotline is 
preliminary and may change before a meeting is actually held. The 
hotline

[[Page 32444]]

will be updated when such changes are made.
MEETINGS: The following advisory committee meetings are announced:
Transmissible Spongiform Encephalopathies Advisory Committee Meeting 
(formerly Ad Hoc Advisory Committee on Creutzfeldt-Jakob Disease)
    Date, time, and place. July 2, 1996, 1 p.m., Woodmont I Bldg., 
conference room 200S, 1401 Rockville Pike, Rockville, MD.
    Type of meeting and contact person. This meeting will be held by a 
telephone conference call. A speaker telephone will be provided in the 
conference room to allow public participation in the meeting. Open 
public hearing 1 p.m. to 2 p.m., unless public participation does not 
last that long; open committee discussion, 2 p.m. to 5 p.m.; Linda A. 
Smallwood, Center for Biologics Evaluation and Research (HFM-350), Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
827-3514, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Transmissible Spongiform 
Encephalopathies Advisory Committee, code 12388. Please call the 
hotline for information concerning any possible changes.
    General function of the committee. The committee reviews and 
evaluates available scientific data concerning the safety of products 
which may be at risk for transmission of spongiform encephalopathies 
having an impact on the public health.
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Those desiring to make formal presentations should 
notify the contact person before June 24, 1996, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time required to make their comments.
    Open committee discussion. The committee will review and discuss 
revised precautionary measures to reduce the possible risk of 
transmission of Creutzfeldt-Jakob Disease by blood and blood products. 
FDA regrets that it was unable to publish this notice 15 days prior to 
the July 2, 1996, Transmissible Spongiform Encephalopathies Advisory 
Committee meeting. Because the agency believes there is some urgency to 
bring this issue to public discussion and qualified members of the 
Transmissible Spongiform Encephalopathies Advisory Committee were 
available at this time, the Commissioner concluded that it was in the 
public interest to hold this meeting even if there was not sufficient 
time for the customary 15-day public notice.
-National Mammography Quality Assurance Advisory Committee
    -Date, time, and place. July 10, 11, and 12, 1996, 9 a.m., 
DoubleTree Hotel--Rockville, Main Ballroom, 1750 Rockville Pike, 
Rockville, MD. A limited number of overnight accommodations have been 
reserved at the DoubleTree Hotel--Rockville. Attendees requiring 
overnight accommodations may contact the hotel at 301-468-1100 and 
reference the FDA committee meeting block, group code 0301. 
Reservations will be confirmed at the group rate based on availability.
    -Type of meeting and contact person. Open public hearing, July 10, 
1996, 9 a.m. to 10 a.m., unless public participation does not last that 
long; open committee discussion, 10 a.m. to 5 p.m.; open committee 
discussion, July 11, 1996, 9 a.m. to 5 p.m.; open subcommittee 
discussions, July 12, 1996, 9 a.m. to 1 p.m.; open committee 
discussion, 1 p.m. to 5 p.m.; Charles K. Showalter, Center for Devices 
and Radiological Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3332, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), National Mammography Quality Assurance Advisory 
Committee, code 12397. Please call the hotline for information 
concerning any possible changes.
    -General function of the committee. The committee advises on 
developing appropriate quality standards and regulations for the use of 
mammography facilities.
    -Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Those desiring to make formal presentations should 
notify the contact person before July 5, 1996, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time required to make their comments.
    -Open committee discussion. On July 10, 1996, the committee will 
hear updates on approvals for alternative standards under the 
Mammography Quality Standards Act (MQSA) of 1992. On July 10 and 11, 
1996, the committee will discuss digital mammography under the MQSA. On 
July 12, 1996, the committee will discuss the issue of States as 
certifying bodies under the MQSA as well as the ongoing work of the 
three subcommittees: Access to Mammography Services, Physicists 
Availability, and Cost Benefit of Compliance.
    -Open subcommittee discussions. On July 12, 1996, the three 
subcommittees will meet concurrently. The subcommittees will discuss 
information which is necessary to make the determinations and 
subsequently prepare the reports as mandated in the MQSA. Upon 
completion, the subcommittee reports will be reviewed by the committee 
prior to submission to the Secretary and Congress.
 Medical Imaging Drugs Advisory Committee
     Date, time, and place. July 22, 1996, 8:30 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda, 
MD.
     Type of meeting and contact person. Open public hearing, July 22, 
1996, 8:30 a.m. to 9 a.m., unless public participation does not last 
that long; open committee discussion, 9 a.m. to 2:30 p.m.; open public 
hearing, 2:30 p.m. to 3 p.m.; William Freas or Sheila D. Langford, 
Center for Biologics Evaluation and Research (HFM-21), Food and Drug 
Administration, 1401 Rockville Pike, Bethesda, MD 20852, 301-827-0314, 
or Leander Madoo, Center for Drug Evaluation and Research (HFD-21), 
5600 Fishers Lane, Rockville, MD 20857, 301-443-4695, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Medical Imaging Drugs Advisory Committee, code 
12540. Please call the hotline for information concerning any possible 
changes.
     General function of the committee. The committee reviews and 
evaluates data concerning the safety and effectiveness of marketed and 
investigational human drug products for use in diagnostic and 
therapeutic procedures using radioactive pharmaceuticals and contrast 
media used in diagnostic radiology.
     Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Those desiring to make formal presentations should 
notify the contact person before July 15, 1996, and

[[Page 32445]]

submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of the proposed 
participants, and the indication of the approximate time required to 
make their comments.
     Open committee discussion. The committee will discuss the Center 
for Biologics Evaluation and Research's product license application 95-
0041 for Prostascint<SUP>TM (Cytogen Corp.), a radiolabeled monoclonal 
antibody designed to detect sites of metastatic cancer which express 
the prostate specific membrane antigen.
-Obstetrics and Gynecology Devices Panel of the Medical Devices 
Advisory Committee
    -Date, time, and place. July 22 and 23, 1996, 8:30 a.m., 
Gaithersburg Marriott Washingtonian Center, Ballroom, 9751 
Washingtonian Blvd., Gaithersburg, MD; July 24, 1996, 8:30 a.m., 
Corporate Bldg., conference room 020B, 9200 Corporate Blvd., Rockville, 
MD. A limited number of overnight accommodations have been reserved at 
the Gaithersburg Marriott Washingtonian Center. Attendees requiring 
overnight accommodations may contact the hotel at 301-590-0044 and 
reference the FDA panel meeting block. Reservations will be confirmed 
at the group rate based on availability. Attendees with a disability 
requiring special accommodations should contact Shirley Meeks, 
Conference Management, 301-594-1283, ext. 113. The availability of 
appropriate accommodations cannot be ensured unless prior notification 
is received.
    -Type of meeting and contact person.  Open committee discussion, 
July 22, 1996, 8:30 a.m. to 2 p.m.; open public hearing, 2 p.m. to 3 
p.m., unless public participation does not last that long; open 
committee discussion, 3 p.m. to 7 p.m.; open committee discussion, July 
23, 1996, 8:30 a.m. to 11 a.m.; open public hearing, 11 a.m. to 11:30 
a.m., unless public participation does not last that long; open 
committee discussion, 11:30 a.m. to 3 p.m.; open public hearing, 3 p.m. 
to 3:30 p.m., unless public participation does not last that long; open 
committee discussion, 3:30 p.m. to 7 p.m.; open committee discussion, 
July 24, 1996, 8:30 a.m. to 12 m.; Alfred W. Montgomery, Center for 
Devices and Radiological Health (HFZ-470), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1180, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Obstetrics and Gynecology 
Devices Panel, code 12524. Please call the hotline for information 
concerning any possible changes.
    -General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational devices and makes recommendations for their regulation.
    -Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Those desiring to make formal presentations should 
notify the contact person before July 12, 1996, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time required to make their comments.
    -Open committee discussion. On July 22, 1996, the committee will be 
asked to consider new technological advances in intrapartum electronic 
fetal monitoring (EFM). After hearing a series of presentations on the 
subject, the committee will discuss appropriate recommended testing for 
such new technology applications. FDA will consider these 
recommendations in the future development of testing guidelines. 
Committee deliberations on this subject will continue to the second 
day, July 23, 1996. FDA recognizes that there continues to be questions 
asked about EFM and its place in the clinical management of the patient 
in labor. The intent of the committee discussion is not to resolve 
issues related to clinical practice and clinical standards in the area 
of EFM. Rather, the focus of discussions will be on reasonable study 
methodologies for establishing the safety and effectiveness of the new 
fetal monitoring technologies.
     On July 23, 1996, following the discussions on new technological 
advances in intrapartum EFM, the committee will discuss and vote on a 
premarket approval application (PMA) for an implantable stent used for 
in utero treatment of fetal postvesicular uropathy. Also, on July 23, 
1996, following deliberations on the above PMA, the committee will 
discuss and vote on a PMA for a silicone barrier contraceptive device. 
On July 24, 1996, the committee will continue deliberations on the 
contraceptive device PMA.
-Anti-Infective Drugs Advisory Committee
    -Date, time, and place. July 24, 25, and 26, 1996, 8:30 a.m., 
Holiday Inn--Silver Spring, Grand Ballroom, 8777 Georgia Ave., Silver 
Spring, MD.
    -Type of meeting and contact person. Open public hearing, July 24, 
1996, 8:30 a.m. to 9 a.m., unless public participation does not last 
that long; open committee discussion, 9 a.m. to 5 p.m.; open committee 
discussion, July 25, 1996, 8:30 a.m. to 5 p.m.; open public hearing, 
July 26, 1996, 8:30 a.m. to 9 a.m., unless public participation does 
not last that long; open committee discussion, 9 a.m. to 2 p.m.; Ermona 
B. McGoodwin or Danyiel D'Antonio, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-5455, or FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), Anti-Infective Drugs Advisory Committee, code 12530. Please call 
the hotline for information concerning any possible changes.
    -General function of the committee.  The committee reviews and 
evaluates available data concerning the safety and effectiveness of 
marketed and investigational human drug products for use in the 
treatment of infectious diseases and disorders.
    -Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Those desiring to make formal presentations should 
notify the contact person before July 19, 1996, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time required to make their comments.
    -Open committee discussion. On July 24, 1996, the committee will 
discuss issues relevant to: (1) The use of silver sulfadiazine cream 1% 
in the treatment of patients with chronic wounds; and (2) new drug 
application (NDA) 19-832, Sulfamylon<Register> Solution 5% (mafenide 
acetate, Mylan Pharmaceuticals, Inc.) for the control of bacterial 
colonization under moist dressings over meshed autografts on excised 
burn wounds. On July 25 and 26, 1996, the committee will discuss 
antibiotic resistance issues. In light of the significant public health 
impact of increasing bacterial resistance on the future usefulness of 
antimicrobial agents, FDA is soliciting from the advisory committee 
opinions and advice regarding the development of policy for 
antimicrobial drugs intended for the treatment of multidrug resistant 
(MDR) organisms. Issues for discussion include labeling for the 
treatment of MDR organism(s), and labeling as second line

[[Page 32446]]

therapy versus empiric therapy since widespread empiric use may 
decrease the drug's potential usefulness for treating MDR organisms. 
The agency encourages investigators, academicians, and members of the 
pharmaceutical industry with information relevant to the treatment of 
infections caused by MDR organisms, including current approaches to 
antimicrobial drug development, to respond to this notice.
    FDA public advisory committee meetings may have as many as four 
separable portions: (1) An open public hearing, (2) an open committee 
discussion, (3) a closed presentation of data, and (4) a closed 
committee deliberation. Every advisory committee meeting shall have an 
open public hearing portion. Whether or not it also includes any of the 
other three portions will depend upon the specific meeting involved. 
There are no closed portions for the meetings announced in this notice. 
The dates and times reserved for the open portions of each committee 
meeting are listed above.
    The open public hearing portion of each meeting shall be at least 1 
hour long unless public participation does not last that long. It is 
emphasized, however, that the 1 hour time limit for an open public 
hearing represents a minimum rather than a maximum time for public 
participation, and an open public hearing may last for whatever longer 
period the committee chairperson determines will facilitate the 
committee's work.
    Public hearings are subject to FDA's guideline (subpart C of 21 CFR 
part 10) concerning the policy and procedures for electronic media 
coverage of FDA's public administrative proceedings, including hearings 
before public advisory committees under 21 CFR part 14. Under 21 CFR 
10.205, representatives of the electronic media may be permitted, 
subject to certain limitations, to videotape, film, or otherwise record 
FDA's public administrative proceedings, including presentations by 
participants.
    Meetings of advisory committees shall be conducted, insofar as is 
practical, in accordance with the agenda published in this Federal 
Register notice. Changes in the agenda will be announced at the 
beginning of the open portion of a meeting.
    Any interested person who wishes to be assured of the right to make 
an oral presentation at the open public hearing portion of a meeting 
shall inform the contact person listed above, either orally or in 
writing, prior to the meeting. Any person attending the hearing who 
does not in advance of the meeting request an opportunity to speak will 
be allowed to make an oral presentation at the hearing's conclusion, if 
time permits, at the chairperson's discretion.
    The agenda, the questions to be addressed by the committee, and a 
current list of committee members will be available at the meeting 
location on the day of the meeting.
    Transcripts of the open portion of the meeting may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 15 working days after the meeting, at a cost of 10 cents 
per page. The transcript may be viewed at the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857, approximately 15 working days after the meeting, 
between the hours of 9 a.m. and 4 p.m., Monday through Friday. Summary 
minutes of the open portion of the meeting may be requested in writing 
from the Freedom of Information Office (address above) beginning 
approximately 90 days after the meeting.
    This notice is issued under section 10(a)(1) and (2) of the Federal 
Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR 
part 14) on advisory committees.

    Dated: June 14, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-15942 Filed 6-21-96; 8:45 am]
BILLING CODE 4160-01-F