81 FR 2222 - How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 10 (January 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 10 (January 15, 2016)
| Page Range | 2222-2223 | |
| FR Document | 2016-00690 |
[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)] [Notices] [Pages 2222-2223] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00690] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0128 (formerly Docket No. 2007D-0396)] How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials? AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public conference entitled ``How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?'' This conference will be cosponsored with the Critical Path Institute (C- Path). The purpose of the conference is to discuss, debate, and share views among stakeholders in academia, patient groups, regulatory bodies, and the health care and pharmaceutical industries on how best to measure, evaluate, and act upon liver injury and dysfunction caused by drugs used during clinical trials. DATES: This public conference will be held on March 23, 2016, from 8 a.m. to 6 p.m., and on March 24, 2016, from 8 a.m. to 4 p.m. ADDRESSES: This public conference will be held at the College Park Marriott Hotel & Conference Center, 3501 University Blvd., East Hyattsville, MD 20783. The hotel's phone number is 301-985-7300. FOR FURTHER INFORMATION CONTACT: Lana L. Pauls, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4478, Silver Spring, MD 20993-0002, 301- 796-0518, lana.pauls@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In July 2009, FDA announced the availability of a guidance for industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical Evaluation'' (74 FR 38035, July 30, 2009, https://www.thefederalregister.org/fdsys/pkg/FR-2009-07-30/pdf/E9-18135.pdf). First, this guidance explains that drug-induced liver injury (DILI) has been the most frequent cause [[Page 2223]] of safety-related drug marketing withdrawals over the past 50 years and that hepatotoxicity has both limited the use of many drugs that have been approved and prevented the approval of others. Second, this guidance discusses methods of detecting DILI by periodic tests of serum enzyme activities and of bilirubin concentration and how changes in the results of these laboratory tests over time, along with symptoms and physical findings, may be used to estimate the severity of the injury. Third, this guidance suggests some ``stopping rules'' for interrupting drug treatment and mentions the need to obtain sufficient clinical information to assess causation. FDA published a draft of this guidance in 2006, and comments on that draft were taken into consideration when issuing the final guidance in July 2009. II. Conference Information The purpose of the 2016 conference is to invite participants to present their data and views and to hold an open discussion. The meetings in recent years have been attended by members of industry, regulatory bodies, and academic consultants, and the topics discussed have included several unresolved issues on which consensus was sought. Registration: A registration fee ($650 for industry registrants and $325 for Federal government and academic registrants) will be charged to help defray the cost of renting the meeting space, providing meals and snacks, and covering the travel fees incurred by invited academic (but not government or industry) speakers, as well as any other expenses. The registration process will be handled by C-Path, an independent, nonprofit organization established in 2005 with public and private philanthropic support from the southern Arizona community, Science Foundation Arizona, and FDA. Additional information on the conference, program, and registration procedures may be obtained on the Internet at http://www.c-path.org, and at http://www.fda.gov by typing ``liver toxicity'' into the search box. (FDA has verified the Web site addresses but is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. Materials presented at past programs (from 2007 to 2015) (including copies of slides shown, comments made about the slides, and discussions following the slides) may be accessed at http://www.aasld.org/events-professional-development/drug-induced-liver-injury-2015-program. (FDA has verified this Web site address but is not responsible for any subsequent changes to it after this document publishes in the Federal Register.) Dated: January 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-00690 Filed 1-14-16; 8:45 am] BILLING CODE 4164-01-P
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‘‘reasonably needed to treat, diagnose, petition to modify the ADN if additional availability of the draft guidance
or cure a population of 4,000 information arises. entitled ‘‘Humanitarian Device
individuals in the United States’’, and On August 5, 2008, FDA issued a Exemption: Questions and Answers;
therefore shall be based on the following guidance entitled ‘‘Guidance for HDE Draft Guidance for Humanitarian Device
information in a HDE application: The Holders, Institutional Review Boards Exemption Holders, Institutional
number of devices reasonably necessary (IRBs), Clinical Investigators, and Food Review Boards, Clinical Investigators,
to treat such individuals. and Drug Administration Staff— and Food and Drug Administration
Humanitarian Device Exemption (HDE) Staff’’, that when finalized, will
Section 520(m)(6)(A)(iii) of the FD&C Regulation: Questions and Answers’’
Act (http://www.fda.gov/Regulatory represent FDA’s current thinking on this
(http://www.fda.gov/downloads/ topic.
Information/Legislation/Federal MedicalDevices/DeviceRegulationand
FoodDrugandCosmeticActFDCAct/ Guidance/GuidanceDocuments/ FDA is requesting the extension of
FDCActChapterVDrugsandDevices/ ucm110203.pdf). The guidance was OMB approval for the collection of
default.htm) provides that an HDE developed and issued prior to the information required under the statutory
holder immediately notify the Agency if enactment of FDASIA, and certain mandate of sections 515A (21 U.S.C.
the number of devices distributed sections of this guidance may no longer 360e–1) and 520(m) of the FD&C Act as
during any calendar year exceeds the be current as a result of FDASIA. In the amended.
ADN. Section 520(m)(6)(C) of the FD&C Federal Register of March 18, 2014 (79 FDA estimates the burden of this
Act provides that an HDE holder may FR 15130), FDA announced the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of Average
Number of Total annual
Activity/section of FD&C Act (as amended) or FDASIA responses per burden per Total hours
respondents responses
respondent response
Pediatric Subpopulation and Patient Information—
515A(a)(2) of the FD&C Act ............................................. 6 1 6 100 600
Exemption from Profit Prohibition Information—
520(m)(6)(A)(i) and (ii) of the FD&C Act .......................... 3 1 3 50 150
Request for Determination of Eligibility Criteria—613(b) of
FDASIA ............................................................................. 2 1 2 10 20
ADN Notification—520(m)(6)(A)(iii) of the FD&C Act .......... 1 1 1 100 100
ADN Modification—520(m)(6)(C) of the FD&C Act ............. 5 1 5 100 500
Total .............................................................................. ........................ ........................ ........................ ........................ 1,370
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s Center for Devices and DEPARTMENT OF HEALTH AND dysfunction caused by drugs used
Radiological Health receives an HUMAN SERVICES during clinical trials.
estimated average of six HDE DATES: This public conference will be
applications per year. FDA estimates Food and Drug Administration held on March 23, 2016, from 8 a.m. to
that three of these applications will be 6 p.m., and on March 24, 2016, from 8
indicated for pediatric use. We estimate [Docket No. FDA–2008–D–0128 (formerly a.m. to 4 p.m.
Docket No. 2007D–0396)]
that we will receive approximately two ADDRESSES: This public conference will
requests for determination of eligibility How Should Liver Injury and be held at the College Park Marriott
criteria per year. FDA estimates that Dysfunction Caused by Drugs Be Hotel & Conference Center, 3501
very few or no HDE holders will notify Measured, Evaluated, and Acted Upon University Blvd., East Hyattsville, MD
the Agency that the number of devices in Clinical Trials? 20783. The hotel’s phone number is
distributed in the year has exceeded the 301–985–7300.
ADN. FDA estimates that five HDE AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
holders will petition to have the ADN HHS. Lana L. Pauls, Center for Drug
modified due to additional information ACTION: Notice of public conference. Evaluation and Research, Food and
on the number of individuals affected Drug Administration, 10903 New
SUMMARY: The Food and Drug Hampshire Ave., Bldg. 22, Rm. 4478,
by the disease or condition.
Administration (FDA) is announcing a Silver Spring, MD 20993–0002, 301–
Dated: January 11, 2016. public conference entitled ‘‘How Should 796–0518, lana.pauls@fda.hhs.gov.
Leslie Kux, Liver Injury and Dysfunction Caused by SUPPLEMENTARY INFORMATION:
Associate Commissioner for Policy. Drugs Be Measured, Evaluated, and
Acted Upon in Clinical Trials?’’ This I. Background
[FR Doc. 2016–00691 Filed 1–14–16; 8:45 am]
conference will be cosponsored with the In July 2009, FDA announced the
BILLING CODE 4164–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
Critical Path Institute (C-Path). The availability of a guidance for industry
purpose of the conference is to discuss, entitled ‘‘Drug-Induced Liver Injury:
debate, and share views among Premarketing Clinical Evaluation’’ (74
stakeholders in academia, patient FR 38035, July 30, 2009, https://
groups, regulatory bodies, and the www.gpo.gov/fdsys/pkg/FR-2009-07-30/
health care and pharmaceutical pdf/E9-18135.pdf). First, this guidance
industries on how best to measure, explains that drug-induced liver injury
evaluate, and act upon liver injury and (DILI) has been the most frequent cause
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![Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices 2223
of safety-related drug marketing either hardcopy or on CD–ROM, after neighborhood organizations in order to:
withdrawals over the past 50 years and submission of a Freedom of Information Identify best practices and successful
that hepatotoxicity has both limited the request. The Freedom of Information modes of delivering social services;
use of many drugs that have been office address is available on the evaluate the need for improvements in
approved and prevented the approval of Agency’s Web site at http:// the implementation and coordination of
others. Second, this guidance discusses www.fda.gov. public policies relating to faith- based
methods of detecting DILI by periodic Materials presented at past programs and other neighborhood organizations;
tests of serum enzyme activities and of (from 2007 to 2015) (including copies of and make recommendations for changes
bilirubin concentration and how slides shown, comments made about the in policies, programs, and practices.
changes in the results of these slides, and discussions following the Contact Person for Additional
laboratory tests over time, along with slides) may be accessed at http:// Information: Please contact Ben O’Dell
symptoms and physical findings, may www.aasld.org/events-professional- for any additional information about the
be used to estimate the severity of the development/drug-induced-liver-injury- President’s Advisory Council meeting at
injury. Third, this guidance suggests 2015-program. (FDA has verified this partnerships@hhs.gov.
some ‘‘stopping rules’’ for interrupting Web site address but is not responsible Agenda: For February 1, the agenda
drug treatment and mentions the need for any subsequent changes to it after will begin with an Opening and
to obtain sufficient clinical information this document publishes in the Federal Welcome from the Chairperson and
to assess causation. FDA published a Register.) Executive Director for the President’s
draft of this guidance in 2006, and Dated: January 8, 2016. Advisory Council for Faith-based and
comments on that draft were taken into
Leslie Kux, Neighborhood Partnership. Then there
consideration when issuing the final
Associate Commissioner for Policy. will be presentation of any
guidance in July 2009.
[FR Doc. 2016–00690 Filed 1–14–16; 8:45 am] Recommendations for deliberation and
II. Conference Information BILLING CODE 4164–01–P vote. Lastly, there will be a discussion
The purpose of the 2016 conference is of subgroup deliberation as well as
to invite participants to present their elements being considered for
data and views and to hold an open DEPARTMENT OF HEALTH AND recommendations. For February 2, there
discussion. The meetings in recent years HUMAN SERVICES will presentations on work to address
have been attended by members of poverty and income inequality after a
industry, regulatory bodies, and Meeting Notice for the President’s welcome and opening from the
academic consultants, and the topics Advisory Council on Faith-Based and Chairperson and Executive Director for
discussed have included several Neighborhood Partnerships the President’s Advisory Council.
unresolved issues on which consensus In accordance with section 10(a)(2) of Public Comment: There will be an
was sought. the Federal Advisory Committee Act opportunity for public comment at the
Registration: A registration fee ($650 (Pub. L. 92–463), the President’s end of the meeting. Comments and
for industry registrants and $325 for Advisory Council on Faith-based and questions can be sent in advance to
Federal government and academic Neighborhood Partnerships announces partnerships@hhs.gov.
registrants) will be charged to help the following meetings: Dated: January 11, 2016.
defray the cost of renting the meeting Name: President’s Advisory Council Ben O’Dell,
space, providing meals and snacks, and on Faith-based and Neighborhood Associate Director for Center for Faith-based
covering the travel fees incurred by Partnerships Council Meetings. and Neighborhood Partnerships at U.S.
invited academic (but not government Time and Date: Monday, February Department of Health and Human Services.
or industry) speakers, as well as any 1st, 2016 1:00 p.m.–5:00 p.m. (EST) and [FR Doc. 2016–00767 Filed 1–14–16; 8:45 am]
other expenses. The registration process Tuesday, February 2nd, 2016 10:00 BILLING CODE 4154–07–P
will be handled by C-Path, an a.m.–1:00 p.m. (EST).
independent, nonprofit organization Place: Meeting will be held at a
established in 2005 with public and location to be determined in the White DEPARTMENT OF HEALTH AND
private philanthropic support from the House complex, 1600 Pennsylvania Ave HUMAN SERVICES
southern Arizona community, Science NW., Washington, DC. Space is
Foundation Arizona, and FDA. extremely limited. Photo ID and RSVP National Institutes of Health
Additional information on the by January 25, 2016 are required to
conference, program, and registration attend the event. Please RSVP to Ben Center for Scientific Review; Notice of
procedures may be obtained on the O’Dell at partnerships@hhs.gov. Closed Meetings
Internet at http://www.c-path.org, and at The meeting will be available to the
http://www.fda.gov by typing ‘‘liver public through a conference call line. Pursuant to section 10(d) of the
toxicity’’ into the search box. (FDA has Register to participate in the conference Federal Advisory Committee Act, as
verified the Web site addresses but is call on Monday, February 1st at the Web amended (5 U.S.C. App.), notice is
not responsible for any subsequent site https://attendee.gotowebinar.com/ hereby given of the following meetings.
changes to the Web sites after this register/7321886895235169026. Register The meetings will be closed to the
document publishes in the Federal to participate in the conference call on public in accordance with the
Register.) Tuesday, February 2nd at the Web site provisions set forth in sections
mstockstill on DSK4VPTVN1PROD with NOTICES
Transcripts: Please be advised that as https://attendee.gotowebinar.com/ 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
soon as a transcript is available, it will register/4788059050490531842. as amended. The grant applications and
be accessible at http:// Status: Open to the public, limited the discussions could disclose
www.regulations.gov. It may be viewed only by space available. Conference call confidential trade secrets or commercial
at the Division of Dockets Management, limited only by lines available. property such as patentable material,
Food and Drug Administration, 5630 Purpose: The Council brings together and personal information concerning
Fishers Lane, Rm. 1061, Rockville, MD. leaders and experts in fields related to individuals associated with the grant
A transcript will also be available in the work of faith-based and applications, the disclosure of which
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Document Created: 2018-02-02 12:31:47
Document Modified: 2018-02-02 12:31:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public conference. | |
| Dates | This public conference will be held on March 23, 2016, from 8 a.m. to 6 p.m., and on March 24, 2016, from 8 a.m. to 4 p.m. | |
| Contact | Lana L. Pauls, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4478, Silver Spring, MD 20993-0002, 301- 796-0518, [email protected] | |
| FR Citation | 81 FR 2222 |
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