Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting; Reopening of Comment Period, 53509-53510 [E9-25022]
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Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices
4.0
5.0
expert panel to complete its work.
Anticipated agenda topics for each day
are listed below.
Products
Reproductive Toxicity Data
Summary, Conclusions, and
Critical Data Needs (to be
developed at the expert panel
meeting).
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Attendance and Registration
In order to facilitate planning for this
meeting, persons wishing to attend are
asked to register by December 9, 2009,
via the CERHR Web site (https://
cerhr.niehs.nih.gov).
Preliminary Agenda
The meeting begins each day at 8:30
a.m. On December 16 and 17, it is
anticipated that a lunch break will occur
from noon–1 p.m. and the meeting will
adjourn at 5–6 p.m. The meeting is
expected to adjourn by noon on
December 18, 2009; however,
adjournment may occur earlier or later
depending upon the time needed by the
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• Opening remarks;
• Oral public comments (7 minutes
per speaker; one representative per
group);
• Review of chapters 1–4 of the draft
expert panel report on soy formula;
• Discussion of Chapter 5.0
Summary, Conclusions, and Critical
Data Needs.
December 17, 2009
• Discussion of Chapter 5.0
Summary, Conclusions, and Critical
Data Needs;
• Preparation of draft summaries and
conclusion statements.
December 18, 2009
• Presentation, discussion of, and
agreement on summaries, conclusions,
and data needs;
• Closing comments.
Background Information on the CERHR
The NTP established CERHR in 1998
(63 FR 68782). CERHR is a publicly
accessible resource for information
about adverse reproductive and/or
developmental health effects associated
with exposure to environmental and/or
occupational exposures. CERHR follows
a formal process for the evaluation of
selected substances that includes
opportunities for public input.
CERHR invites the nomination of
substances for review or scientists for its
expert registry. Information about
CERHR and the nomination process can
be obtained from its homepage (https://
cerhr.niehs.nih.gov) or by contacting Dr.
Thayer (see ADDRESSES above). CERHR
selects substances for evaluation based
upon several factors including
production volume, potential for human
exposure from use and occurrence in
the environment, extent of public
concern, and extent of data from
reproductive and developmental
toxicity studies. Expert panels conduct
scientific evaluations of substances
selected by CERHR in public forums.
Following these evaluations, CERHR
prepares the NTP–CERHR monograph
on the substance evaluated. The
monograph is transmitted to appropriate
Federal and State agencies and made
available to the public.
Dated: October 8, 2009.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. E9–25122 Filed 10–16–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
December 16, 2009
Request for Comments
CERHR invites written public
comments on chapters 1–4 of the draft
expert panel report on soy formula. Any
comments received will be posted on
the CERHR Web site prior to the
meeting and distributed to the expert
panel and CERHR staff for their
consideration in revising the draft report
and/or preparing for the expert panel
meeting. Persons submitting written
comments are asked to include their
name and contact information
(affiliation, mailing address, telephone
number, e-mail, and sponsoring
organization, if any) and send them to
Dr. Thayer (see ADDRESSES above) for
receipt by December 2, 2009. Comments
will be identified on the Web site by the
submitter’s name, affiliation, and/or
sponsoring organization.
Time is set aside on December 16,
2009 for the presentation of oral public
comments at the expert panel meeting.
Seven minutes will be available for each
speaker (one speaker per organization).
Online registration is available on the
CERHR website or persons wishing to
make oral remarks can contact Dr.
Thayer. If possible, send a copy of the
statement, talking points, and/or slide
presentation to Dr. Thayer by December
2. This statement will be provided to the
expert panel to assist them in
identifying issues for discussion and
noted in the meeting record.
Registration for presentation of oral
comments will also be available at the
meeting on December 16, 2009, from
7:30–8:30 a.m. Persons registering at the
meeting are asked to bring 30 copies of
their statement, talking points, and/or
slide presentation for distribution to the
expert panel and for the record.
53509
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[Docket No. FDA–2009–N–0143]
Risk Evaluation and Mitigation
Strategies for Certain Opioid Drugs;
Notice of Public Meeting; Reopening of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice; reopening of comment
period.
SUMMARY: The Food and Drug
Administration (FDA) is reopening until
October 19, 2010, the comment period
for the notice of public meeting
published in the Federal Register of
April 20, 2009 (74 FR 17967). In that
notice, FDA announced a public
meeting that took place on May 27 and
28, 2009, to solicit input on developing
Risk Evaluation and Mitigation
Strategies (REMS) for certain opioid
drugs. FDA is reopening the comment
period in light of continued public
interest in this topic and to provide an
opportunity for all interested parties to
provide information and share views on
the matter.
DATES: Submit written or electronic
comments by October 19, 2010.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Theresa (Terry) Martin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6196,
Silver Spring, MD 20993–0002, 301–
796–3448; FAX: 301–847–8752, e-mail:
OpioidREMS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 20,
2009 (74 FR 17967), FDA published a
notice of a public meeting on
developing REMS for certain opioid
drugs. The affected opioid drugs include
long acting and extended release brand
name and generic products that are
formulated with the following active
ingredients: Fentanyl, hydromorphone,
methadone, morphine, oxycodone, and
oxymorphone. The REMS would be
intended to ensure that the benefits of
these drugs continue to outweigh risks
associated with: (1) Use of high doses of
long acting opioid and extended release
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Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices
opioid products in non-opioid tolerant
and inappropriately selected
individuals; (2) abuse; (3) misuse; and
(4) overdose, both accidental and
intentional. REMS for these opioids
would likely include elements to assure
safe use to ensure that prescribers,
dispensers, and patients are aware of
and understand the risks and proper use
of these products. The opioid drugs
expected to be subject to REMS are
widely prescribed by a large number of
physicians who practice in a wide
variety of areas. A REMS that will
adequately manage the risks of these
products without unduly burdening the
health care system or reducing patient
access to these medications must be
carefully designed. Recognizing this
challenge, we identified several specific
areas in which FDA wishes to obtain
information and public comment in our
April 2009 notice of public meeting.
Interested persons were originally
given until June 30, 2009, to comment.
As a result of continued public interest,
FDA is reopening the comment period
until October 19, 2010 to allow
interested persons additional time to
provide information and share views on
this topic.
II. How to Submit 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 to https://www.regulations.gov
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.
Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25022 Filed 10–16–09; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: OMB–48, InfoPass System;
New Information Collection; Comment
Request
ACTION: 30-Day Notice of Information
Collection Under Review: OMB–48,
InfoPass System.
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) has
submitted the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on July 28, 2009, at 74 FR
37234, allowing for a 60-day public
comment period. USCIS did not receive
any comments.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until November 18,
2009. This process is conducted in
accordance with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB), USCIS
Desk Officer. Comments may be
submitted to: USCIS, Chief, Regulatory
Products Division, Clearance Office, 111
Massachusetts Avenue, Washington, DC
20529–2210. Comments may also be
submitted to DHS via facsimile to 202–
272–8352 or via e-mail at
rfs.regs@dhs.gov, and to the OMB USCIS
Desk Officer via facsimile at 202–395–
5806 or via e-mail at
oira_submission@omb.eop.gov.
When submitting comments by email, please make sure to add OMB–48
in the subject box. Written comments
and suggestions from the public and
affected agencies should address one or
more of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
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(2) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This Information
Collection
(1) Type of Information Collection:
New Information collection.
(2) Title of the Form/Collection:
InfoPass System.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: No Agency
Form Number; File No. OMB–48. U.S.
Citizenship and Immigration Services.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
Households. The InfoPass system allows
an applicant or petitioner to schedule an
interview appointment with USCIS
through USCIS’ Internet Web site.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 1,043,319 responses at 6
minutes (.10) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 104,332 annual burden
hours.
If you need a copy of the information
collection instrument, please visit the
Web site at: https://www.regulations.gov/
We may also be contacted at: USCIS,
Regulatory Products Division, 111
Massachusetts Avenue, NW.,
Washington, DC 20529–2210,
Telephone number 202–272–8377.
Dated: October 14, 2009.
Stephen Tarragon,
Deputy Chief, Regulatory Products Division,
U.S. Citizenship and Immigration Services.
[FR Doc. E9–25042 Filed 10–16–09; 8:45 am]
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[Federal Register Volume 74, Number 200 (Monday, October 19, 2009)]
[Notices]
[Pages 53509-53510]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25022]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0143]
Risk Evaluation and Mitigation Strategies for Certain Opioid
Drugs; Notice of Public Meeting; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening until
October 19, 2010, the comment period for the notice of public meeting
published in the Federal Register of April 20, 2009 (74 FR 17967). In
that notice, FDA announced a public meeting that took place on May 27
and 28, 2009, to solicit input on developing Risk Evaluation and
Mitigation Strategies (REMS) for certain opioid drugs. FDA is reopening
the comment period in light of continued public interest in this topic
and to provide an opportunity for all interested parties to provide
information and share views on the matter.
DATES: Submit written or electronic comments by October 19, 2010.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Theresa (Terry) Martin, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993-0002, 301-
796-3448; FAX: 301-847-8752, e-mail: OpioidREMS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 20, 2009 (74 FR 17967), FDA
published a notice of a public meeting on developing REMS for certain
opioid drugs. The affected opioid drugs include long acting and
extended release brand name and generic products that are formulated
with the following active ingredients: Fentanyl, hydromorphone,
methadone, morphine, oxycodone, and oxymorphone. The REMS would be
intended to ensure that the benefits of these drugs continue to
outweigh risks associated with: (1) Use of high doses of long acting
opioid and extended release
[[Page 53510]]
opioid products in non-opioid tolerant and inappropriately selected
individuals; (2) abuse; (3) misuse; and (4) overdose, both accidental
and intentional. REMS for these opioids would likely include elements
to assure safe use to ensure that prescribers, dispensers, and patients
are aware of and understand the risks and proper use of these products.
The opioid drugs expected to be subject to REMS are widely prescribed
by a large number of physicians who practice in a wide variety of
areas. A REMS that will adequately manage the risks of these products
without unduly burdening the health care system or reducing patient
access to these medications must be carefully designed. Recognizing
this challenge, we identified several specific areas in which FDA
wishes to obtain information and public comment in our April 2009
notice of public meeting.
Interested persons were originally given until June 30, 2009, to
comment. As a result of continued public interest, FDA is reopening the
comment period until October 19, 2010 to allow interested persons
additional time to provide information and share views on this topic.
II. How to Submit 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 to https://www.regulations.gov 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.
Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25022 Filed 10-16-09; 8:45 am]
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