Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Notices 54059 

6. What action should FDA take when 

companies disseminate violative 

promotional material to consumers? 

For most prescription drugs and all 

devices, there is no requirement that 

companies submit their promotional 

materials to FDA before using them, and 

the U.S. Constitution limits the agency’s 

ability to preclear promotional 

materials. Rather, companies must 

submit prescription drug promotional 

pieces at the time of their initial use in 

public. Device promotional pieces are 

not subject to a submission requirement. 

Under section 502(n) of the act, FDA 

can require that sponsors obtain 

preapproval of prescription drug 

advertisements only in ‘‘extraordinary 

circumstances.’’ As a result, FDA’s 

review of promotional materials is 

almost wholly post hoc, (i.e., after the 

materials have already appeared in 

public). Consequently, any enforcement 

action that FDA takes will also be post 

hoc. 

Most of FDA’s enforcement actions 

ask sponsors to stop using the violative 

materials. In some cases, for both 

professional- and consumer-directed 

pieces, FDA also asks sponsors to run 

corrective advertisements or issue 

corrective promotional materials to 

remedy misimpressions created by false 

or misleading materials. The agency is 

interested in hearing views on this type 

of enforcement approach for consumerdirected promotional materials as well 

as other enforcement approaches that 

might protect the public health. 

IV. Notice of Hearing Under Part 15 

The Commissioner of Food and Drugs 

(the Commissioner) is announcing that 

the public hearing will be held in 

accordance with part 15. The 

Commissioner will designate a 

presiding officer, who will be 

accompanied by senior management 

from the Office of the Commissioner, 

the Center for Biologics Evaluation and 

Research, CDER, CDRH, and the Center 

for Veterinary Medicine. 

Persons who wish to make an oral 

presentation during the part 15 hearing 

must file a written or electronic notice 

of participation with the Division of 

Dockets Management (see Addresses). 

To ensure timely handling, any outer 

envelope or subject heading should be 

clearly marked with the docket number 

found in brackets in the heading of this 

document along with the statement 

‘‘Consumer-Directed Promotion of 

Medical Products.’’ Groups should 

submit two written copies. The notice of 

participation should contain the 

person’s name; address; telephone 

number; affiliation, if any; the sponsor 

of the presentation (e.g., the 

organization paying travel expenses or 

fees), if any; a brief summary of the 

presentation (including the specific 

discussion questions that will be 

addressed); and approximate amount of 

time requested for the presentation. The 

agency requests that interested persons 

and groups having similar interests 

consolidate their comments and present 

them through a single representative. 

After reviewing the notices of 

participation and accompanying 

information, FDA will schedule each 

appearance and notify each participant 

by telephone of the time allotted to the 

person and the approximate time the 

person’s oral presentation is scheduled 

to begin. FDA asks that participants set 

aside both days of the meeting so that 

the agency can group presentations on 

similar topics. The agency will let the 

participants know as soon as possible 

the time and date the participant is 

scheduled to present. FDA may also ask 

participants to rank order presentation 

topics, and FDA may need to restrict the 

time allotted to each participant. If time 

permits, FDA may allow interested 

persons attending the hearing who did 

not submit a written or electronic notice 

of participation in advance to make an 

oral presentation at the conclusion of 

the hearing. The hearing schedule will 

be available at the hearing. After the 

hearing, the hearing schedule will be 

placed on file in the Division of Dockets 

Management under the docket number 

found in brackets in the heading of this 

document. 

Because of limited seating at the 

conference facility, FDA requests that 

organizations restrict their number of 

attendees at the meeting to five. 

Under § 15.30, the hearing is informal, 

and the rules of evidence do not apply. 

No participant may interrupt the 

presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. 

Public hearings under part 15 are 

subject to FDA’s policy and procedures 

for electronic media coverage of FDA’s 

public administrative proceedings (part 

10, subpart C (21 CFR part 10, subpart 

C)). Under § 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. The hearing will be 

transcribed as stipulated in § 15.30(b). 

Any handicapped persons requiring 

special accommodations to attend the 

hearing should direct those needs to the 

contact person (see For further 

information contact). 

To the extent that the conditions for 

the hearing, as described in this notice, 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

those provisions as specified in 

§ 15.30(h). 

V. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

Addresses) written or electronic notices 

of participation and comments for 

consideration at the hearing. To permit 

time for all interested persons to submit 

data, information, or views on this 

subject, the administrative record of the 

hearing will remain open following the 

hearing. Persons who wish to provide 

additional materials for consideration 

should file these materials with the 

Division of Dockets Management. You 

should annotate and organize your 

comments to identify the specific 

questions to which they refer (see 

section III of this document). Two 

copies of any mailed comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number at the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Transcripts of the hearing also will be 

available for review at the Division of 

Dockets Management. 

VI. Transcripts 

The transcript of the hearing will be 

available 30 days after the hearing on 

the Internet at http://www.fda.gov/ 

ohrms/dockets, and orders for copies of 

the transcript can be placed at the 

meeting or through the Freedom of 

Information Staff (HFI–35), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. 

Dated: September 6, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18040 Filed 9–9–05; 8:52 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[DHS–2005–0061] 

Data Privacy and Integrity Advisory 

Committee 

AGENCY: Office of the Secretary, 

Department of Homeland Security. 

54060 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Notices 

ACTION: Notice of Federal Advisory 

Committee meeting. 

SUMMARY: The notice announces the 

date, time, location, and agenda for the 

next meeting of the Department of 

Homeland Security Data Privacy and 

Integrity Advisory Committee. This 

meeting will include a partially closed 

session. 

DATES: This meeting will be held on 

Wednesday, September 28, 2005, in 

Bellingham, Washington. 

ADDRESSES: The Department of 

Homeland Security Data Privacy and 

Integrity Advisory Committee meeting 

will be held in the Ballroom at the Hotel 

Bellwether, One Bellwether Way, 

Bellingham, Washington, 98225. If you 

wish to submit comments, you must do 

so by September 20, 2005. Comments 

must be identified by DHS–2005–0061 

and may be submitted by one of the 

following methods: 

• EPA Federal Partner EDOCKET Web 

site: http://www.epa.gov/feddocket. 

Follow instructions for submitting 

comments on the Web site. 

• E-mail: PrivacyCommittee@dhs.gov. 

Include docket number in the subject 

line of the message. 

• Fax: 571–227–4171. 

• Mail: Ms. Rebecca J. Richards, 

Executive Director, Data Privacy and 

Integrity Advisory Committee, 

Department of Homeland Security, 

Arlington, VA 22202. 

Instructions: All submissions received 

must include the Department of 

Homeland Security and DHS–2005–

0061, the docket number for this action. 

All comments received will be posted 

without change to http://www.epa.gov/ 

feddocket, including any personal 

information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.epa.gov/feddocket. You may also 

access the Federal eRulemaking Portal 

at http://www.regulations.gov. 

ADDRESSES: Persons who are unable to 

attend or speak at the meeting may 

submit comments at any time. 

• E-mail: PrivacyCommittee@dhs.gov. 

• Fax: (571) 227–4171. 

• Mail: Rebecca J. Richards, Executive 

Director, Data Privacy and Integrity 

Advisory Committee, Department of 

Homeland Security, Arlington, VA 

22202. 

All comments received will be posted 

without change to http://www.dhs.gov/ 

privacy, including any personal 

information provided. 

FOR FURTHER INFORMATION CONTACT: 

Nuala O’Connor Kelly, Chief Privacy 

Officer, or Rebecca J. Richards, 

Executive Director, Data Privacy and 

Integrity Advisory Committee, 

Department of Homeland Security, 

Arlington, VA 22202 by telephone (571) 

227–3813, by facsimile (571) 227–4171, 

or by e-mail 

PrivacyCommittee@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Department of Homeland Security 

(DHS) Data Privacy and Integrity 

Advisory Committee (Committee) will 

be meeting on Wednesday, September 

28, 2005, in the Ballroom at the Hotel 

Bellwether, One Bellwether Way, 

Bellingham, Washington, 98225. The 

meeting will begin at 8:30 a.m. and 

continue until 5 p.m. Although most of 

the meeting is open to the public, there 

will be a closed session between 12:30 

p.m. and 2 p.m., during which 

Committee members will receive a 

sensitive briefing regarding screening 

programs proposed for the 

Transportation Security 

Administration’s Secure Flight Program. 

In the morning, the Committee will 

receive a report from the Chief Privacy 

Officer of DHS, the Federal Privacy 

Commissioner of Canada, and the 

Assistant Administrator for the Secure 

Flight program of the Transportation 

Security Administration (TSA). Reports 

from two of the four subcommittees, and 

a panel presentation about the use of 

radio frequency identification 

technology, will conclude the morning 

session. In the afternoon, the remaining 

two subcommittees will report to the 

Committee, and there will be a panel 

discussion about risk-based analysis and 

privacy from privacy and technology 

experts. 

Public comments will be accepted 

during the meeting, between 4:30 p.m. 

and 5 p.m., All those who wish to testify 

during this time may register in advance 

or sign-up on the day of the meeting. In 

order to allow as many people as 

possible to testify, witnesses should 

limit their remarks to three minutes. 

Due to limited seating, any member of 

the public who wishes to attend the 

public session should provide his or her 

name no later than 12 p.m. E.S.T., 

Friday, September 23, 2005, to Rebecca 

J. Richards via email at 

PrivacyCommittee@dhs.gov, or via 

telephone at (571) 227–3813. 

Photo identification will be required 

for entry on the day of the meeting to 

verify those individuals who have 

registered for the public session, and 

everyone who plans to attend should be 

present and seated by 8:15 a.m., or 1:45 

p.m., if only attending the afternoon 

session. Registration information 

required for attendance will be used for 

verification purposes on the day of the 

meeting. Attendance information, 

including names of members of the 

public attending, may be made public as 

part of the official meeting minutes. 

Persons with disabilities who require 

special assistance should indicate this 

in their admittance request and are 

encouraged to identify anticipated 

special needs as early as possible. 

Although every effort will be made to 

accommodate all members of the public, 

seating is limited and will be allocated 

on a first-come, first-served basis. 

Basis for Closure 

In accordance with Section 10(d) of 

the Federal Advisory Committee Act, 

Public Law 92–463, as amended, 86 

Stat. 770, the Secretary of Homeland 

Security has determined that a portion 

of this Privacy Advisory Committee 

meeting, as referenced above, is 

excluded from the Open Meetings 

requirement pursuant to the authority 

contained in 5 U.S.C. 552b(c)(9)(B). 

Dated: September 9, 2005. 

Nuala O’Connor Kelly, 

Chief Privacy Officer. 

[FR Doc. 05–18264 Filed 9–12–05; 8:45 am] 

BILLING CODE 4410–10–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[CGD07–05–115] 

Announcement of Public Hearing 

Regarding the Shakett Creek 

Pedestrian Bridge, Nokomis, FL 

Formerly Known as the Shakett Creek 

Railroad Bridge 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of public hearing. 

SUMMARY: The U.S. Coast Guard will 

hold a public hearing at the Venice High 

School, 1 Indian Avenue, Venice, 

Florida 34285 to provide the Shakett 

Creek Pedestrian Bridge owner, 

waterway users and other interested 

persons the opportunity to offer 

evidence and be heard as to whether 

any alterations of the Shakett Creek 

Pedestrian Bridge in Nokomis, Florida 

are necessary to provide reasonably free, 

safe and unobstructed passage for 

waterborne traffic. 

DATES: The public hearing will be held 

at 7 p.m., October 12, 2005. 

ADDRESSES: The hearing will be held at 

the Venice High School, 1 Indian 

Avenue, Venice, Florida 34285. Written 

comments may be submitted to 

Commander (obr), Seventh Coast Guard 

District, 909 SE 1st Avenue, Room 432,