Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop, 15993-15994 [E9-7993]
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Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices
Submit written requests for
single copies of the guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002; or the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. The
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. Send two self-addressed
adhesive labels to assist the office in
processing your requests. Requests and
comments should be identified with the
docket number found in brackets in the
heading of this document. Submit
written comments on the guidance 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. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H.
King, Sr., Center for Drug
Evaluation and Research (HFD–
003), Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4150,
Silver Spring, MD 20993–0002,
301–796–1242; or Christopher
Joneckis, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448, 301–
827–0373.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
rwilkins on PROD1PC63 with NOTICES
ADDRESSES:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
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17:05 Apr 07, 2009
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reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In the Federal Register of August 5,
2008 (73 FR 45467), FDA published a
notice announcing the availability of a
draft tripartite guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 4C: Microbiological
Examination of Non-Sterile Products:
Acceptance Criteria for Pharmaceutical
Preparations and Substances for
Pharmaceutical Use General Chapter.’’
The notice gave interested persons an
opportunity to submit comments by
October 6, 2008.
After consideration of the comments
received and revisions to the guidance,
a final draft guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 4C: Microbiological
Examination of Nonsterile Products:
Acceptance Criteria for Pharmaceutical
Preparations and Substances for
Pharmaceutical Use General Chapter’’
was submitted to the ICH Steering
Committee and endorsed by the three
participating regulatory agencies in
November 2008.
The guidance provides the specific
evaluation outcome from the ICH Q4B
process for the Microbiological
Examination of Nonsterile Products:
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15993
Acceptance Criteria for Pharmaceutical
Preparations and Substances for
Pharmaceutical Use General Chapter
harmonization proposal originating
from the three-party PDG. This guidance
is in the form of an annex to the core
ICH Q4B guidance. When implemented,
the annex will provide guidance for
industry and regulators on the use of the
specific pharmacopoeial texts evaluated
by the ICH Q4B process. Following
receipt of comments on the draft, no
substantive changes were made to the
annex.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding the guidance.
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. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/cder/guidance/index.htm,
or https://www.fda.gov/cber/
guidelines.htm.
Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7905 Filed 4–7–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration.
[Docket No. FDA–2009–N–0167]
Propylthiouracyl (PTU)-Related Liver
Toxicity; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\08APN1.SGM
08APN1
15994
Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices
ACTION: Notice of public workshop;
request for comments.
rwilkins on PROD1PC63 with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
1-day public workshop, cosponsored
with the American Thyroid Association
(ATA), entitled ‘‘Propylthiouracyl
(PTU)-Related Liver Toxicity.’’ This
public workshop is intended to provide
a public forum for discussion of the
clinical, scientific, and regulatory issues
pertaining to PTU-induced hepatitis to
seek constructive input from academia,
regulatory scientists, and other
interested parties on the topic of PTUinduced hepatitis. The input from this
public workshop will help the ATA to
develop guidelines for the management
of hyperthyroidism and help inform
FDA about necessary changes to
prescription drug labeling for PTU.
DATES: This public workshop will be
held on Saturday, April 18, 2009, from
8 a.m. to 3:30 p.m. However, depending
on the level of public participation, the
meeting may be extended or may end
early. Written or electronic comments
will be accepted after the workshop
until June 19, 2009.
ADDRESSES: The public workshop will
be held at the Madison Hotel at 1177
15th St., NW., Washington, DC 20005,
202–862–1600. We are opening a docket
to receive your written or electronic
comments. Written or electronic
comments must be submitted to the
docket by June 19, 2009.
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.
Comments should be identified with
the docket number found in brackets in
the heading of this document.
Transcripts of the workshop will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.regulations.gov
approximately 45 days after the
workshop.
FOR FURTHER INFORMATION CONTACT: Jeff
O’Neill, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6167, Silver Spring,
MD 20903, 301–796–0777, FAX: 301–
847–8753, e-mail:
jeff.o’neill@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
PTU-related liver toxicity has been
reported in the published literature, and
while direct comparative studies to
another approved anti-thyroid
VerDate Nov<24>2008
17:05 Apr 07, 2009
Jkt 217001
medication, methimazole, are lacking,
case series and postmarketing adverse
event reports suggest a greater risk
associated with PTU than methimazole.
From prescription usage data, it appears
that PTU is used less frequently than
methimazole with perhaps a preferential
use during pregnancy because of
concerns about a rare congenital defect
described in case reports of
methimazole use. However, some data
question whether an advantage of PTU
use over methimazole exists, even
during pregnancy.
FDA and ATA are sponsoring this
open public discussion involving
academia, regulatory scientists, and
other interested parties on the topic of
PTU-induced hepatitis, because it is
important to the health of patients with
thyroid disease that the applicable
scientific, clinical, and regulatory issues
are raised and fully elucidated, and, to
the greatest extent possible, consensus
is reached.
The ATA serves clinicians, scientists,
and patients to facilitate open
interchange and dissemination of
scientific knowledge. The workshop is
intended to provide a forum for
discussion of the clinical, scientific, and
regulatory issues pertaining to PTUinduced hepatitis.
II. Registration
There is no fee to attend the
workshop, and attendees do not need to
register. Seating will be on a first-come,
first-served basis. If you need special
accommodations because of disability,
please contact Jeff O’Neill (see FOR
FURTHER INFORMATION CONTACT) at least 7
days before the workshop.
Dated: April 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7993 Filed 4–7–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Meeting; Advisory Council on
Blood Stem Cell Transplantation
AGENCY: Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of Meeting of the
Advisory Council on Blood Stem Cell
Transplantation.
SUMMARY: Pursuant to Public Law 92–
463, the Federal Advisory Committee
Act, as amended (5 U.S.C. Appendix 2),
PO 00000
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notice is hereby given of the fourth
meeting of the Advisory Council on
Blood Stem Cell Transplantation
(ACBSCT), Department of Health and
Human Services (HHS). The meeting
will be held from approximately 8:30
a.m. to 5 p.m. on May 12, 2009, at the
Bethesda North Marriott Hotel and
Convention Center, 5701 Marinelli
Road, Bethesda, MD 20852. The meeting
will be open to the public; however,
seating is limited and pre-registration is
encouraged (see below).
SUPPLEMENTARY INFORMATION: Pursuant
to Public Law 109–129, 42 U.S.C. 274k
(section 379 of the Public Health Service
Act, as amended), the ACBSCT was
established to advise the Secretary of
HHS and the Administrator, HRSA, on
matters related to the activities of the
C.W. Bill Young Cell Transplantation
Program (Program) and the National
Cord Blood Inventory (NCBI) Program.
ACBSCT is composed of up to 25
members, including the Chair, serving
as Special Government Employees. The
current membership includes
representatives of marrow donor centers
and marrow transplant centers;
representatives of cord blood banks and
participating birthing hospitals;
recipients of a bone marrow transplant;
recipients of a cord blood transplant;
persons who require such transplants;
family members of such a recipient or
family members of a patient who has
requested the assistance of the Program
in searching for an unrelated donor of
bone marrow or cord blood; persons
with expertise in bone marrow and cord
blood transplantation; persons with
expertise in typing, matching, and
transplant outcome data analysis;
persons with expertise in the social
sciences; basic scientists with expertise
in the biology of adult stem cells;
ethicists; hematology and transfusion
medicine researchers with expertise in
adult blood stem cells; persons with
expertise in cord blood processing; and
members of the general public.
The Council will hear reports from
three ACBSCT Work Groups: Cord
Blood Accreditation Organization and
Recognition Process, Scientific Factors
Necessary to Define a Cord Blood Unit
as High Quality, and Informed Consent.
The Council also will hear presentations
and discussions on the following topics:
recent clinical developments and
current issues, adult donor recruitment:
Strategies and challenges, and future
council activities.
The draft meeting agenda and a
registration form will be available on or
about April 13, 2009, on HRSA’s
Program Web site at https://
bloodcell.transplant.hrsa.gov/ABOUT/
E:\FR\FM\08APN1.SGM
08APN1
Agencies
[Federal Register Volume 74, Number 66 (Wednesday, April 8, 2009)]
[Notices]
[Pages 15993-15994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7993]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration.
[Docket No. FDA-2009-N-0167]
Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop
AGENCY: Food and Drug Administration, HHS.
[[Page 15994]]
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-day
public workshop, cosponsored with the American Thyroid Association
(ATA), entitled ``Propylthiouracyl (PTU)-Related Liver Toxicity.'' This
public workshop is intended to provide a public forum for discussion of
the clinical, scientific, and regulatory issues pertaining to PTU-
induced hepatitis to seek constructive input from academia, regulatory
scientists, and other interested parties on the topic of PTU-induced
hepatitis. The input from this public workshop will help the ATA to
develop guidelines for the management of hyperthyroidism and help
inform FDA about necessary changes to prescription drug labeling for
PTU.
DATES: This public workshop will be held on Saturday, April 18, 2009,
from 8 a.m. to 3:30 p.m. However, depending on the level of public
participation, the meeting may be extended or may end early. Written or
electronic comments will be accepted after the workshop until June 19,
2009.
ADDRESSES: The public workshop will be held at the Madison Hotel at
1177 15th St., NW., Washington, DC 20005, 202-862-1600. We are opening
a docket to receive your written or electronic comments. Written or
electronic comments must be submitted to the docket by June 19, 2009.
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.
Comments should be identified with the docket number found in
brackets in the heading of this document.
Transcripts of the workshop will be available for review at the
Division of Dockets Management and on the Internet at https://www.regulations.gov approximately 45 days after the workshop.
FOR FURTHER INFORMATION CONTACT: Jeff O'Neill, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6167, Silver Spring, MD 20903, 301-796-
0777, FAX: 301-847-8753, e-mail: jeff.o'neill@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
PTU-related liver toxicity has been reported in the published
literature, and while direct comparative studies to another approved
anti-thyroid medication, methimazole, are lacking, case series and
postmarketing adverse event reports suggest a greater risk associated
with PTU than methimazole. From prescription usage data, it appears
that PTU is used less frequently than methimazole with perhaps a
preferential use during pregnancy because of concerns about a rare
congenital defect described in case reports of methimazole use.
However, some data question whether an advantage of PTU use over
methimazole exists, even during pregnancy.
FDA and ATA are sponsoring this open public discussion involving
academia, regulatory scientists, and other interested parties on the
topic of PTU-induced hepatitis, because it is important to the health
of patients with thyroid disease that the applicable scientific,
clinical, and regulatory issues are raised and fully elucidated, and,
to the greatest extent possible, consensus is reached.
The ATA serves clinicians, scientists, and patients to facilitate
open interchange and dissemination of scientific knowledge. The
workshop is intended to provide a forum for discussion of the clinical,
scientific, and regulatory issues pertaining to PTU-induced hepatitis.
II. Registration
There is no fee to attend the workshop, and attendees do not need
to register. Seating will be on a first-come, first-served basis. If
you need special accommodations because of disability, please contact
Jeff O'Neill (see FOR FURTHER INFORMATION CONTACT) at least 7 days
before the workshop.
Dated: April 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7993 Filed 4-7-09; 8:45 am]
BILLING CODE 4160-01-S