[Federal Register Volume 61, Number 203 (Friday, October 18, 1996)]
[Notices]
[Pages 54447-54448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Advisory Committee Meeting; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of a meeting of the National Mammography 
Quality Assurance Advisory Committee, which is scheduled for October 
21, 22, and 23, 1996. This meeting was announced in the Federal 
Register of September 24, 1996 (61 FR 50031 at 50033). The amendment is 
being made to add a closed session to the agenda scheduled for October 
23, 1996. There are no other changes. This amendment will be announced 
at the beginning of the open portion of the meeting.

FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for 
Devices and Radiological Health (HFZ-240), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 24, 
1996, FDA announced that a meeting of the National Mammography Quality 
Assurance Advisory Committee would be held on October 21, 22, and 23, 
1996.
    On page 50033, in the first column, the ``Type of meeting and 
contact person'' portion is amended as follows:
    Type of meeting and contact person. Open public hearing, October 
21, 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, October 22, 1996, 9 a.m. to 5 p.m.; open committee 
discussion, October 23, 1996, 8 a.m. to 10 a.m.; closed committee 
deliberations, 10 a.m. to 10:30 a.m.; open committee discussion, 10:30 
a.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.
    On page 50033, in the second column, in addition to the open 
committee discussion of the request of the American Board of 
Certification in Radiology to be designated as eligible to certify 
interpreting physicians under the Mammography Quality Standards Act 
(the MQSA), a ``Closed committee deliberations'' portion is added as 
follows:
    Closed committee deliberations. On October 23, 1996, the committee 
will discuss confidential commercial information submitted in 
connection with the request of the American Board of Certification in 
Radiology to be designated as eligible to certify interpreting 
physicians under the MQSA. This portion of the meeting will be closed 
to permit discussion of this information (5 U.S.C. 552b(c)(4)).
    Each public advisory committee meeting listed above 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. The dates and times reserved for the separate portions of 
each committee meeting are listed above.
    The open public hearing portion of the meeting(s) 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, 5600 Fishers Lane, rm. 12A-16, 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, 12420 Parklawn Dr., rm. 1-23, 
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.
    The Commissioner has determined for the reasons stated that those 
portions of the advisory committee meetings so designated in this 
notice shall be closed. The Federal Advisory Committee Act

[[Page 54448]]

(FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee 
meetings in certain circumstances. Those portions of a meeting 
designated as closed, however, shall be closed for the shortest 
possible time, consistent with the intent of the cited statutes.
    The FACA, as amended, provides that a portion of a meeting may be 
closed where the matter for discussion involves a trade secret; 
commercial or financial information that is privileged or confidential; 
information of a personal nature, disclosure of which would be a 
clearly unwarranted invasion of personal privacy; investigatory files 
compiled for law enforcement purposes; information the premature 
disclosure of which would be likely to significantly frustrate 
implementation of a proposed agency action; and information in certain 
other instances not generally relevant to FDA matters.
    Examples of portions of FDA advisory committee meetings that 
ordinarily may be closed, where necessary and in accordance with FACA 
criteria, include the review, discussion, and evaluation of drafts of 
regulations or guidelines or similar preexisting internal agency 
documents, but only if their premature disclosure is likely to 
significantly frustrate implementation of proposed agency action; 
review of trade secrets and confidential commercial or financial 
information submitted to the agency; consideration of matters involving 
investigatory files compiled for law enforcement purposes; and review 
of matters, such as personnel records or individual patient records, 
where disclosure would constitute a clearly unwarranted invasion of 
personal privacy.
    Examples of portions of FDA advisory committee meetings that 
ordinarily shall not be closed include the review, discussion, and 
evaluation of general preclinical and clinical test protocols and 
procedures for a class of drugs or devices; consideration of labeling 
requirements for a class of marketed drugs or devices; review of data 
and information on specific investigational or marketed drugs and 
devices that have previously been made public; presentation of any 
other data or information that is not exempt from public disclosure 
pursuant to the FACA, as amended; and, deliberation to formulate advice 
and recommendations to the agency on matters that do not independently 
justify closing.
    This notice is issued under section 10(a)(1) and (a)(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: October 15, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-26915 Filed 10-16-96; 12:37 pm]
BILLING CODE 4160-01-F