Draft Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Reopening of Comment Period; Public Conference, 12181-12182 [E8-4361]
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mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 73, No. 45 / Thursday, March 6, 2008 / Notices
allow the applicant to measure
consumer acceptance of the product and
assess commercial feasibility.
DATES: This permit is effective for 15
months, beginning on the date the
permit holder introduces or causes the
introduction of the test product into
interstate commerce, but not later than
June 6, 2008.
FOR FURTHER INFORMATION CONTACT: Ritu
Nalubola, Center for Food Safety and
Applied Nutrition (HFS–820), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–2371.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 130.17
concerning temporary permits to
facilitate market testing of foods
deviating from the requirements of the
standards of identity issued under
section 401 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341), FDA
is giving notice that a temporary permit
has been issued to Yardarm Knot
Fisheries, LLC, 3600 15th Ave. West,
suite 300, Seattle, WA 98119.
The permit covers limited interstate
marketing tests of a product identified
as Yardarm Knot ‘‘Skinless and
Boneless Sockeye Salmon.’’ This canned
salmon product may deviate from the
U.S. standard of identity for canned
Pacific salmon (§ 161.170 (21 CFR
161.170)) in that the product is prepared
by removing the skin and bones of the
salmon used. Therefore, in addition to
the optional forms of pack provided in
§ 161.170(a)(3), this temporary
marketing permit provides for an
alternative ‘‘skinless and boneless’’ form
of pack. The test product meets all the
requirements of the standard with the
exception of the ‘‘skinless and boneless’’
form of pack. The purpose of the
temporary permit is to allow the
applicant to measure consumer
acceptance of the product, identify mass
production problems, and assess
commercial feasibility.
This permit provides for the
temporary marketing of not more than
1.35 million pounds (or 612 thousand
kilograms) of the test product. The test
product will be manufactured by
Yardarm Knot Fisheries, LLC, at Mile
1.5 Alaska Peninsula Highway, Naknek,
Alaska 99633. The test product will be
distributed by Yardarm Knot Fisheries,
LLC, throughout the United States. The
information panel of the label will bear
nutrition labeling in accordance with 21
CFR 101.9. Each of the ingredients used
in the food will be declared on the label
as required by the applicable sections of
21 CFR part 101. This permit is effective
for 15 months, beginning on the date the
permit holder introduces or causes the
VerDate Aug<31>2005
16:57 Mar 05, 2008
Jkt 214001
introduction of the product into
interstate commerce, but not later than
(see DATES).
Dated: February 28, 2008.
Barbara Schneeman,
Director, Office of Nutritional Products,
Labeling and Dietary Supplements, Center for
Food Safety and Applied Nutrition.
[FR Doc. E8–4316 Filed 3–5–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0128] (formerly
Docket No. 2007D–0396)
Draft Guidance for Industry on DrugInduced Liver Injury: Premarketing
Clinical Evaluation; Reopening of
Comment Period; Public Conference
AGENCY:
Food and Drug Administration,
HHS.
Notice of reopening of comment
period; notice of public conference.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is reopening until
June 30, 2008, the comment period for
the draft guidance for industry entitled
‘‘Drug-Induced Liver Injury:
Premarketing Clinical Evaluation,’’
published in the Federal Register of
October 25, 2007 (72 FR 60681). FDA is
also announcing a public conference
entitled ‘‘Detecting and Investigating
Drug-Induced Liver Injury During
Clinical Trials.’’ FDA is cosponsoring
the conference with the American
Association for the Study of Liver
Diseases (AASLD) and the
Pharmaceutical and Research
Manufacturers of America. The purpose
of the conference is to discuss the draft
guidance and to solicit additional input
on the issues and questions presented in
this document.
DATES: The public conference will be
held on March 26, 2008, from 8 a.m. to
6 p.m. and March 27, 2008, from 8 a.m.
to 3 p.m. Please register by March 14,
2008, to make an oral presentation
during the open public session on
March 27, 2008. Submit written or
electronic comments on the draft
guidance, the conference program and
presentations, and the issues and
questions presented in this document by
June 30, 2008.
ADDRESSES: The public conference will
be held at the National Labor College
(NLC), 10000 New Hampshire Ave.,
Silver Spring, MD 20903.
Submit written comments to the
Division of Dockets Management (HFA–
PO 00000
Frm 00112
Fmt 4703
Sfmt 4703
12181
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 draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Lana L. Pauls, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, e-mail:
lana.pauls@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Reopening of Comment Period for the
Draft Guidance
In the Federal Register of October 25,
2007, FDA issued the draft guidance
‘‘Drug-Induced Liver Injury:
Premarketing Clinical Evaluation’’ and
invited comments by December 24,
2007. This draft guidance describes
methods for detecting drug-induced
liver injury (DILI) that may occur during
the course of conducting controlled
clinical trials. To provide interested
persons additional time to review the
draft guidance and submit comments,
the agency is reopening the comment
period until June 30, 2008.
II. The Public Conference
A. Why Are We Holding This Public
Conference?
The purpose of the conference is to
discuss the draft guidance and issues
that it may raise and to solicit additional
input on the issues and questions
presented in this document.
B. What Are the Topics We Intend to
Address at the Conference?
We hope to discuss a large number of
issues at the conference, including, but
not limited to:
• The approach to detecting the
potential for severe DILI described in
the draft guidance;
• What stopping rules should govern
the administration of an investigational
agent during a clinical trial;
• When should rechallenge of a
suspected injurious agent be considered;
• Should patients or study
participants with stable chronic liver
disease be included in clinical trials;
and
• Other issues and questions raised
by the conference attendees or others.
C. Is There a Fee and How Do I Register
for the Conference?
There is a modest fee to attend the
conference, to defray the costs of meals
provided, rental of the NLC meeting
facility, travel expenses for invited
E:\FR\FM\06MRN1.SGM
06MRN1
12182
Federal Register / Vol. 73, No. 45 / Thursday, March 6, 2008 / Notices
academic (but not government or
industry) speakers, and other expenses.
The fee for the 2-day meeting for
registrants from industry is $350, and
the fee for academic or government
registrants is $175. Fees will be waived
for invited speakers and moderators.
The registration process will be
handled by AASLD, which has
extensive experience in planning,
executing, and organizing educational
meetings. Register online at https://
www.aasld.org. Although the NLC
facility is spacious, registration will be
on a first-come, first-served basis. If you
would like to make an oral presentation
during the open hour of the conference
on March 27, 2008, you must register
with Lana Pauls (see FOR FURTHER
INFORMATION CONTACT) by close of
business on March 14, 2008. To make a
presentation, you will be asked to
provide your name, title, business
affiliation (if applicable), address, and
type of organization you represent (e.g.,
industry, consumer organization).
Persons registered to make an oral
presentation should check in before the
conference. If you need special
accommodations because of a disability,
please contact Lana Pauls at least 7 days
before the conference.
E. Conference Transcripts
We will prepare a transcript of the
conference presentations and
discussions and will post it online along
with copies of slides shown. The
transcript will be available for review on
the Internet at https://www.fda.gov/cder/
livertox approximately 30 days after the
conference.
mstockstill on PROD1PC66 with NOTICES
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding the draft guidance
and the issues and questions presented
in this document or at the conference.
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
Jkt 214001
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
SUPPLEMENTARY INFORMATION:
Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–4361 Filed 3–5–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Summaries of Medical and Clinical
Pharmacology Reviews of Pediatric
Studies; Availability
AGENCY:
ACTION:
Background information on the
conference, registration information, the
agenda, information about lodging, and
other relevant information will be
posted, as it becomes available, on the
Internet at https://www.fda.gov/cder/
livertox and https://www.aasld.org.
16:57 Mar 05, 2008
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6460,
Silver Spring, MD 20993–0002, 301–
796–0700, e-mail:
grace.carmouze@fda.hhs.gov.
Food and Drug Administration,
HHS.
D. Where Can I Find Out More About
This Public Conference?
VerDate Aug<31>2005
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of summaries of medical
and clinical pharmacology reviews of
pediatric studies submitted in
supplements for BETOPTIC (betaxolol),
LAMICTAL (lamotrigine), LEVAQUIN
(levofloxacin), RISPERDAL
(risperidone), and TIMOLOL (timolol).
These summaries are being made
available consistent with the Best
Pharmaceuticals for Children Act (the
BPCA). For all pediatric supplements
submitted under the BPCA, the BPCA
requires FDA to make available to the
public a summary of the medical and
clinical pharmacology reviews of the
pediatric studies conducted for the
supplement.
ADDRESSES: Submit written requests for
single copies of the summaries to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Please specify by
product name which summary or
summaries you are requesting. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
summaries.
PO 00000
Frm 00113
Fmt 4703
Sfmt 4703
I. Background
FDA is announcing the availability of
summaries of medical and clinical
pharmacology reviews of pediatric
studies conducted for BETOPTIC
(betaxolol), LAMICTAL (lamotrigine),
LEVAQUIN (levofloxacin), RISPERDAL
(risperidone), and TIMOLOL (timolol).
The summaries are being made available
consistent with section 9 of the BPCA
(Public Law 107–109). Enacted on
January 4, 2002, the BPCA reauthorizes,
with certain important changes, the
pediatric exclusivity program described
in section 505A of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 355a). Section 505A of the act
permits certain applications to obtain 6
months of marketing exclusivity if, in
accordance with the requirements of the
statute, the sponsor submits requested
information relating to the use of the
drug in the pediatric population.
One of the provisions the BPCA
added to the pediatric exclusivity
program pertains to the dissemination of
pediatric information. Specifically, for
all pediatric supplements submitted
under the BPCA, the BPCA requires
FDA to make available to the public a
summary of the medical and clinical
pharmacology reviews of pediatric
studies conducted for the supplement
(21 U.S.C. 355a(m)(1)). The summaries
are to be made available not later than
180 days after the report on the
pediatric study is submitted to FDA (21
U.S.C. 355a(m)(1)). Consistent with this
provision of the BPCA, FDA has posted
on the Internet at https://www.fda.gov/
cder/pediatric/index.htm summaries of
medical and clinical pharmacology
reviews of pediatric studies submitted
in supplements for BETOPTIC
(betaxolol), LAMICTAL (lamotrigine),
LEVAQUIN (levofloxacin), RISPERDAL
(risperidone), and TIMOLOL (timolol).
Copies are also available by mail (see
ADDRESSES).
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/pediatric/index.htm.
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 73, Number 45 (Thursday, March 6, 2008)]
[Notices]
[Pages 12181-12182]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4361]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0128] (formerly Docket No. 2007D-0396)
Draft Guidance for Industry on Drug-Induced Liver Injury:
Premarketing Clinical Evaluation; Reopening of Comment Period; Public
Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of reopening of comment period; notice of public
conference.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening until June
30, 2008, the comment period for the draft guidance for industry
entitled ``Drug-Induced Liver Injury: Premarketing Clinical
Evaluation,'' published in the Federal Register of October 25, 2007 (72
FR 60681). FDA is also announcing a public conference entitled
``Detecting and Investigating Drug-Induced Liver Injury During Clinical
Trials.'' FDA is cosponsoring the conference with the American
Association for the Study of Liver Diseases (AASLD) and the
Pharmaceutical and Research Manufacturers of America. The purpose of
the conference is to discuss the draft guidance and to solicit
additional input on the issues and questions presented in this
document.
DATES: The public conference will be held on March 26, 2008, from 8
a.m. to 6 p.m. and March 27, 2008, from 8 a.m. to 3 p.m. Please
register by March 14, 2008, to make an oral presentation during the
open public session on March 27, 2008. Submit written or electronic
comments on the draft guidance, the conference program and
presentations, and the issues and questions presented in this document
by June 30, 2008.
ADDRESSES: The public conference will be held at the National Labor
College (NLC), 10000 New Hampshire Ave., Silver Spring, MD 20903.
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. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Lana L. Pauls, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, e-mail:
lana.pauls@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Reopening of Comment Period for the Draft Guidance
In the Federal Register of October 25, 2007, FDA issued the draft
guidance ``Drug-Induced Liver Injury: Premarketing Clinical
Evaluation'' and invited comments by December 24, 2007. This draft
guidance describes methods for detecting drug-induced liver injury
(DILI) that may occur during the course of conducting controlled
clinical trials. To provide interested persons additional time to
review the draft guidance and submit comments, the agency is reopening
the comment period until June 30, 2008.
II. The Public Conference
A. Why Are We Holding This Public Conference?
The purpose of the conference is to discuss the draft guidance and
issues that it may raise and to solicit additional input on the issues
and questions presented in this document.
B. What Are the Topics We Intend to Address at the Conference?
We hope to discuss a large number of issues at the conference,
including, but not limited to:
The approach to detecting the potential for severe DILI
described in the draft guidance;
What stopping rules should govern the administration of an
investigational agent during a clinical trial;
When should rechallenge of a suspected injurious agent be
considered;
Should patients or study participants with stable chronic
liver disease be included in clinical trials; and
Other issues and questions raised by the conference
attendees or others.
C. Is There a Fee and How Do I Register for the Conference?
There is a modest fee to attend the conference, to defray the costs
of meals provided, rental of the NLC meeting facility, travel expenses
for invited
[[Page 12182]]
academic (but not government or industry) speakers, and other expenses.
The fee for the 2-day meeting for registrants from industry is $350,
and the fee for academic or government registrants is $175. Fees will
be waived for invited speakers and moderators.
The registration process will be handled by AASLD, which has
extensive experience in planning, executing, and organizing educational
meetings. Register online at https://www.aasld.org. Although the NLC
facility is spacious, registration will be on a first-come, first-
served basis. If you would like to make an oral presentation during the
open hour of the conference on March 27, 2008, you must register with
Lana Pauls (see FOR FURTHER INFORMATION CONTACT) by close of business
on March 14, 2008. To make a presentation, you will be asked to provide
your name, title, business affiliation (if applicable), address, and
type of organization you represent (e.g., industry, consumer
organization). Persons registered to make an oral presentation should
check in before the conference. If you need special accommodations
because of a disability, please contact Lana Pauls at least 7 days
before the conference.
D. Where Can I Find Out More About This Public Conference?
Background information on the conference, registration information,
the agenda, information about lodging, and other relevant information
will be posted, as it becomes available, on the Internet at https://
www.fda.gov/cder/livertox and https://www.aasld.org.
E. Conference Transcripts
We will prepare a transcript of the conference presentations and
discussions and will post it online along with copies of slides shown.
The transcript will be available for review on the Internet at https://
www.fda.gov/cder/livertox approximately 30 days after the conference.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft
guidance and the issues and questions presented in this document or at
the conference. 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.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4361 Filed 3-5-08; 8:45 am]
BILLING CODE 4160-01-S
