Radioactive Drugs for Certain Research Uses; Public Meeting; Reopening of Comment Period, 24491-24492 [05-9326]
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Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Proposed Rules
Products Inspection Act. The proposed
rule had a 90-day comment period,
which ended December 21, 2004. To
discuss the proposed rule and solicit
comments from interested stakeholders,
FDA held three public meetings in 2004:
October 28 in College Park, MD;
November 9 in Chicago, IL; and
November 16 in Los Angeles, CA.
II. Request for Comments
Based on comments received in
response to the proposal, FDA is seeking
further comment and information on
industry practices and programs that
prevent SE-monitored chicks from being
infected by SE during the period of
pullet rearing until placement into
laying hen houses. Specifically, FDA
seeks additional comment and
supportive data or other information on
the following questions:
1. How many pullet growing facilities
are there in the United States? What is
the range in the number of houses on
those facilities?
• What percentage of pullet growers
are under programs or have practices
aimed at preventing SE-monitored
chicks from becoming infected by SE
during the period of pullet rearing until
placement into layer hen houses?
• Do State or regional Egg Quality
Assurance Programs include provisions
to prevent SE-monitored chicks from
becoming infected by SE during the
period of pullet rearing until placement
into layer hen houses? How effective
have the pullet programs (whatever the
programs entail—cleaning, testing, etc.)
been in reducing the prevalence of SE
in layer flocks? How is effectiveness
measured?
2. During pullet rearing, what
programs or industry practices are
currently taken to prevent SE-monitored
chicks from becoming infected by SE
during the period of pullet rearing until
placement into layer hen houses?
• Are pullets, or their environment,
tested for SE between the time they are
procured as chicks and the time they
enter layer houses? If so, when? When
tested, approximately how often do
pullets or pullet environments test
positive? What happens after a positive
test?
• Is vaccination used as a preventive
measure, if so, when and how?
• What cleaning and disinfecting
practices are common?
• Are measures taken to reduce the
prevalence of rodents and pests in the
pullet rearing houses?
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
VerDate jul<14>2003
14:32 May 09, 2005
Jkt 205001
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Identify comments with the docket
number found in brackets in 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.
Dated: May 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9327 Filed 5–9–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 361
[Docket No. 2004N–0432]
Radioactive Drugs for Certain
Research Uses; Public Meeting;
Reopening of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
reopening of comment period.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is reopening until
July 11, 2005, the comment period on
the questions raised and issues
addressed in the notice of public
meeting, published in the Federal
Register of October 5, 2004 (69 FR
59569), on the use of certain radioactive
drugs for research purposes without an
investigational new drug application
(IND) under the conditions set forth in
FDA regulations. We are taking this
action in response to requests to extend
the comment period and to allow
additional time to review agency
guidance on a related matter.
DATES: Submit written or electronic
comments on the notice and/or public
meeting by July 11, 2005.
ADDRESSES: You may submit comments,
identified by Docket No. 2004N–0432,
by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
• E-mail: fdadockets@oc.fda.gov.
Include Docket No. 2004N–0432 in the
subject line of your e-mail message.
• FAX: 301–827–6870.
PO 00000
Frm 00007
Fmt 4702
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24491
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the agency name and
docket number for this proceeding. All
comments received will be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. For
detailed instructions on submitting
comments, see the ‘‘Comments’’ heading
in the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm and insert Docket No.
2004N–0432 into the ‘‘Search’’ box and
follow the prompts, or go to the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852.
A transcript of the public meeting is
available for review at the Division of
Dockets Management and on the
Internet at https://www.fda.gov/ohrms/
dockets.
FOR FURTHER INFORMATION CONTACT:
Maria R. Walsh, Center for Drug
Evaluation and Research (HFD–103),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–3139, FAX: 301–480–3761, email: walsh@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 5,
2004 (69 FR 59569), we announced a
public meeting to be held on November
16, 2004, to discuss research on
radioactive drugs that is conducted
under § 361.1 (21 CFR 361.1). Under
§ 361.1, certain radioactive drugs (drugs
that exhibit spontaneous disintegration
of unstable nuclei with the emission of
nuclear particles or photons) are
considered generally recognized as safe
and effective under specified conditions
of use when administered to human
research subjects for certain basic
research uses. These uses include
studies intended to obtain basic
information regarding the metabolism
(including pharmacokinetics,
distribution, and localization) of a
radioactive drug or regarding human
physiology, pathophysiology, or
biochemistry, but not studies intended
for immediate therapeutic, diagnostic,
or similar purposes or studies intended
to determine the safety and effectiveness
E:\FR\FM\10MYP1.SGM
10MYP1
24492
Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Proposed Rules
of the drug. When conducted in
accordance with § 361.1, clinical
investigations of radioactive drugs are
not subject to the requirements for INDs
stated in 21 CFR part 312.
To facilitate discussion at the public
meeting and assist us in our review of
this matter, we invited comments on
several questions we set forth in the
Federal Register notice concerning the
application of § 361.1. Interested
persons were invited to present
information at the public meeting and
were given until January 16, 2005, to
submit comments on the notice.
We held the public meeting on
November 16, 2004. Subsequent to the
public meeting, we received requests
from the American College of Nuclear
Physicists, the Society of Nuclear
Medicine, and others that we extend the
comment period on the notice on
§ 361.1 so that persons can consider the
issues raised in the notice and at the
public meeting in light of the
information in the draft guidance on
exploratory INDs that we expected to
issue in the near future. We published
a notice of availability of that draft
guidance in the Federal Register of
April 14, 2005 (70 FR 19764).
In response to these requests, we have
decided to reopen the comment period
on the questions and issues stated in the
October 5, 2004, notice and discussed at
the November 16, 2004, public meeting.
This will allow interested persons more
time to review and comment on these
issues in light of the information in the
draft guidance on exploratory INDs.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in 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.
III. Transcripts
You can examine a transcript of the
November 16, 2004, public meeting on
the Internet at https://www.fda.gov/
ohrms/dockets/default.htm or at the
Division of Dockets Management (see
ADDRESSES), Monday through Friday
between 9 a.m. and 4 p.m. You may also
request a copy of the transcript from the
Freedom of Information Office (HFI–35),
Food and Drug Administration, 5600
Fishers Lane, rm. 12A–16, Rockville,
VerDate jul<14>2003
14:32 May 09, 2005
Jkt 205001
MD 20857, at a cost of 10 cents per page
or on CD at a cost of $14.25 each.
Dated: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9326 Filed 5–9–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[CGD05–05–041]
RIN 1625–AA09
Drawbridge Operation Regulations;
Atlantic Intracoastal Waterway (AICW),
Elizabeth River, Southern Branch, VA
Coast Guard, DHS.
ACTION: Notice of proposed rulemaking.
AGENCY:
SUMMARY: The Coast Guard proposes to
change the regulations that govern the
operation of the Dominion Boulevard
(U.S. 17) Bridge across the Southern
Branch of the Elizabeth River, at
Atlantic Intracoastal Waterway (AICW)
mile 8.8, at Chesapeake, Virginia. The
proposal would change the morning
rush hour closure period so that it starts
at 7 a.m. and ends at 9 a.m., and also
allow the bridge to open every hour
from 9 a.m. to 4 p.m., Monday through
Friday, except holidays. The proposed
change is necessary to relieve vehicular
traffic congestion and reduce traffic
delays between weekday rush hours
while still providing for the reasonable
needs of navigation.
DATES: Comments and related material
must reach the Coast Guard on or before
June 24, 2005.
ADDRESSES: You may mail comments
and related material to Commander
(obr), Fifth Coast Guard District, Federal
Building, 1st Floor, 431 Crawford Street,
Portsmouth, VA 23704–5004. The Fifth
Coast Guard District maintains the
public docket for this rulemaking.
Comments and material received from
the public, as well as documents
indicated in this preamble as being
available in the docket, will become part
of this docket and will be available for
inspection or copying at Commander
(obr), Fifth Coast Guard District between
8 a.m. and 4 p.m., Monday through
Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Waverly W. Gregory, Jr., Bridge
Administrator, Fifth Coast Guard
District, at (757) 398–6222.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
Request for Comments
We encourage you to participate in
this rulemaking by submitting
comments and related material. If you
do so, please include your name and
address, identify the docket number for
this rulemaking CGD05–05–041,
indicate the specific section of this
document to which each comment
applies, and give the reason for each
comment. Please submit all comments
and related material in an unbound
format, no larger than 81⁄2 by 11 inches,
suitable for copying. If you would like
a return receipt, please enclose a
stamped, self-addressed postcard or
envelope. We will consider all
submittals received during the comment
period. We may change this proposed
rule in view of them.
Public Meeting
We do not now plan to hold a public
meeting. But you may submit a request
for a meeting by writing to Commander
(obr), Fifth Coast Guard District at the
address under ADDRESSES explaining
why one would be beneficial. If we
determine that one would aid this
rulemaking, we will hold one public
meeting at a time and place announced
by a later notice in the Federal Register.
Background and Purpose
Current regulations require the
Dominion Boulevard (US 17) Bridge
across the Southern Branch of Elizabeth
River, at AICW mile 8.8, to open on
signal at any time for commercial
vessels carrying liquefied flammable gas
or other hazardous materials and for
commercial vessels that provide a twohour advance notice. In addition, from
Memorial Day to Labor Day, from 8:30
a.m. to 4 p.m., Monday through Friday,
except Federal holidays, the draw is
opened only every hour on the halfhour. From 6:30 a.m. to 8:30 a.m. and
from 4 p.m. to 6 p.m., Monday through
Friday, except Federal holidays, the
draw need not open for the passage of
recreational vessels and commercial
vessels carrying non-hazardous material
that do not provide a 2-hour advance
notice.
On December 17, 2004, we published
a notice of temporary deviation from the
regulations and request for comments
entitled ‘‘Drawbridge Operation
Regulations; Atlantic Intracoastal
Waterway (AICW), Elizabeth River,
Southern Branch, VA’’ in the Federal
Register (69 FR 75472). The temporary
deviation was an effort to test an
alternate drawbridge operation schedule
for 90 days and to solicit comments
from the public. In accordance with the
temporary deviation, from December 13,
E:\FR\FM\10MYP1.SGM
10MYP1
]]>Agencies
[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Proposed Rules]
[Pages 24491-24492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9326]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 361
[Docket No. 2004N-0432]
Radioactive Drugs for Certain Research Uses; Public Meeting;
Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening until July
11, 2005, the comment period on the questions raised and issues
addressed in the notice of public meeting, published in the Federal
Register of October 5, 2004 (69 FR 59569), on the use of certain
radioactive drugs for research purposes without an investigational new
drug application (IND) under the conditions set forth in FDA
regulations. We are taking this action in response to requests to
extend the comment period and to allow additional time to review agency
guidance on a related matter.
DATES: Submit written or electronic comments on the notice and/or
public meeting by July 11, 2005.
ADDRESSES: You may submit comments, identified by Docket No. 2004N-
0432, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include Docket No. 2004N-
0432 in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and docket number for this proceeding. All comments received will be
posted without change to https://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For detailed instructions
on submitting comments, see the ``Comments'' heading in the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm
and insert Docket No. 2004N-0432 into the ``Search'' box and follow the
prompts, or go to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.
A transcript of the public meeting is available for review at the
Division of Dockets Management and on the Internet at https://
www.fda.gov/ohrms/dockets.
FOR FURTHER INFORMATION CONTACT: Maria R. Walsh, Center for Drug
Evaluation and Research (HFD-103), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3139, FAX: 301-480-3761, e-
mail: walsh@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 5, 2004 (69 FR 59569), we
announced a public meeting to be held on November 16, 2004, to discuss
research on radioactive drugs that is conducted under Sec. 361.1 (21
CFR 361.1). Under Sec. 361.1, certain radioactive drugs (drugs that
exhibit spontaneous disintegration of unstable nuclei with the emission
of nuclear particles or photons) are considered generally recognized as
safe and effective under specified conditions of use when administered
to human research subjects for certain basic research uses. These uses
include studies intended to obtain basic information regarding the
metabolism (including pharmacokinetics, distribution, and localization)
of a radioactive drug or regarding human physiology, pathophysiology,
or biochemistry, but not studies intended for immediate therapeutic,
diagnostic, or similar purposes or studies intended to determine the
safety and effectiveness
[[Page 24492]]
of the drug. When conducted in accordance with Sec. 361.1, clinical
investigations of radioactive drugs are not subject to the requirements
for INDs stated in 21 CFR part 312.
To facilitate discussion at the public meeting and assist us in our
review of this matter, we invited comments on several questions we set
forth in the Federal Register notice concerning the application of
Sec. 361.1. Interested persons were invited to present information at
the public meeting and were given until January 16, 2005, to submit
comments on the notice.
We held the public meeting on November 16, 2004. Subsequent to the
public meeting, we received requests from the American College of
Nuclear Physicists, the Society of Nuclear Medicine, and others that we
extend the comment period on the notice on Sec. 361.1 so that persons
can consider the issues raised in the notice and at the public meeting
in light of the information in the draft guidance on exploratory INDs
that we expected to issue in the near future. We published a notice of
availability of that draft guidance in the Federal Register of April
14, 2005 (70 FR 19764).
In response to these requests, we have decided to reopen the
comment period on the questions and issues stated in the October 5,
2004, notice and discussed at the November 16, 2004, public meeting.
This will allow interested persons more time to review and comment on
these issues in light of the information in the draft guidance on
exploratory INDs.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in 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.
III. Transcripts
You can examine a transcript of the November 16, 2004, public
meeting on the Internet at https://www.fda.gov/ohrms/dockets/default.htm
or at the Division of Dockets Management (see ADDRESSES), Monday
through Friday between 9 a.m. and 4 p.m. You may also request a copy of
the transcript from the Freedom of Information Office (HFI-35), Food
and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD
20857, at a cost of 10 cents per page or on CD at a cost of $14.25
each.
Dated: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9326 Filed 5-9-05; 8:45 am]
BILLING CODE 4160-01-S
