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Federal Register / Vol. 72, No.

206 / Thursday, October 25, 2007 / Notices 60681

not established and billed before ACTION: Notice of public workshop. protect against pandemic influenza, and
October 1, 2007, and that there will be (2) facilitate implementation of a global
a gap between the start of the fiscal year The Food and Drug Administration research agenda to improve efficacy
and the date that fees are due. However, (FDA) is announcing a public workshop assessment of pandemic influenza
the voluntary submission of a DTC entitled ‘‘ Immune Correlates of vaccines.
television advertisement for FDA Protection against Influenza A Viruses Transcripts: Transcripts of the public
advisory review on or after October 1, in Support of Pandemic Vaccine workshop may be requested in writing
2007, but before November 26, 2007 will Development.’’ The purpose of the from the Freedom of Information Office
be considered by FDA as notification public workshop is to identify the gaps (HFI–35), Food and Drug
that the company who submitted the in our knowledge and abilities in Administration, 5600 Fishers Lane, rm.
advertisement wishes to participate in addressing the unique challenges 6–30, Rockville, MD 20857,
the program and agrees to pay the encountered in the development and approximately 15 working days after the
advisory review fee and operating evaluation of vaccines intended to public workshop at a cost of 10 cents
reserve fee for each such submission in protect against pandemic influenza. per page. A transcript of the public
a timely manner once the fees for FY Date and Time: The public workshop
workshop will be available on the
2008 are established and the company is will be held on December 10, 2007, from
Internet at http://www.fda.gov/cber/
invoiced. Companies who submit DTC 8:30 a.m. to 5:30 p.m. and December 11,
television advertisements for advisory 2007, from 8 a.m. to 5:15 p.m.
Location: The public workshop will Dated: October 18, 2007.
review in this period should respond to
be held at the Hyatt Regency Bethesda, Jeffrey Shuren,
this participation notice, and include
One Bethesda Metro Center, Bethesda, Assistant Commissioner for Policy.
any such submissions in their count of
MD 20814. For directions, see the hotel [FR Doc. E7–20981 Filed 10–24–07; 8:45 am]
the total number of advisory
Web site at: http://
submissions they intend to submit in FY BILLING CODE 4160–01–S
www.bethesda.hyatt.com or call the
2008. FDA will also contact companies
hotel at 301–657–1234.
who submit DTC television
Contact Person: Maureen Hess, Center DEPARTMENT OF HEALTH AND
advertisements in this time period to
for Biologics Evaluation and Research HUMAN SERVICES
request written confirmation from these
(HFM–405), Food and Drug
companies of their commitment to pay
Administration, 1401 Rockville Pike, Food and Drug Administration
these fees; if companies do not agree to
Rockville, MD 20852, 301–827–5113,
make this commitment, FDA will [Docket No. 2007D–0396]
FAX: 301–827–9781, e-mail:
request that they withdraw their
maureen.hess@fda.hhs.gov. Draft Guidance for Industry on Drug-
submission(s), and such submissions Registration: E-mail or fax your
will not be reviewed. For companies Induced Liver Injury: Premarketing
registration information (including Clinical Evaluation; Availability
who do agree, FDA will begin its name, title, firm name, address,
advisory review of a complete telephone, fax number and e-mail AGENCY: Food and Drug Administration,
submission of a DTC television address) to the contact person by HHS.
advertisement for advisory review on November 19, 2007. There is no ACTION: Notice.
the date that it receives written registration fee for the public workshop.
confirmation of the company’s Early registration is recommended SUMMARY: The Food and Drug
commitment to pay the fees associated because seating is limited. There will be Administration (FDA) is announcing the
with the submission in a timely manner no onsite registration. availability of a draft guidance for
once the company is invoiced. If you need special accommodations industry entitled ‘‘Drug-Induced Liver
For information on how FDA will due to a disability, please contact Ms. Injury: Premarketing Clinical
treat DTC television advertisement Maureen Hess (see Contact Person) at Evaluation.’’ This guidance is intended
advisory review submissions not least 7 days in advance. to assist the pharmaceutical industry
identified in response to this notice that and others engaged in new drug
are submitted after November 26, 2007, development in the assessment of the
Center for Biologics Evaluation and
see sections IV.C ‘‘Additional potential of a drug to cause severe drug-
Research, in cooperation with the
Submissions’’ and IV.E ‘‘Operating induced liver injury (DILI). This
National Institutes of Health’s Division
Reserves’’ of this document. guidance defines severe DILI as injury
of Intramural Research within the
Dated: October 19, 2007. National Institute of Allergy and that is fatal or requires liver
Jeffrey Shuren, Infectious Diseases and the World transplantation. This guidance does not
Assistant Commissioner for Policy. Health Organization, is holding this address the postmarketing evaluation of
[FR Doc. 07–5282 Filed 10–24–07; 8:45 am] public workshop. The public workshop DILI.
BILLING CODE 4160–01–S will include discussions on: (1) Current DATES: Although you can comment on
knowledge regarding correlates of any guidance at any time (see 21 CFR
protection against seasonal influenza, 10.115(g)(5)), to ensure that the agency
DEPARTMENT OF HEALTH AND (2) immune responses to avian influenza considers your comment on this draft
HUMAN SERVICES infections and vaccines for novel guidance before it begins work on the
influenza viruses in humans, (3) assays final version of the guidance, submit
Food and Drug Administration to evaluate vaccine immunogenicity, written or electronic comments on the
and (4) evaluation of avian influenza draft guidance by December 24, 2007.
Immune Correlates of Protection
mstockstill on PROD1PC66 with NOTICES

vaccine efficacy. The goals of the public ADDRESSES: Submit written requests for
Against Influenza A Viruses in Support
workshop are to: (1) Identify the gaps in single copies of the draft guidance to the
of Pandemic Vaccine Development;
our knowledge and abilities in Division of Drug Information (HFD–
Public Workshop
addressing the unique challenges 240), Center for Drug Evaluation and
AGENCY: Food and Drug Administration, encountered in the development and Research, Food and Drug
HHS. evaluation of vaccines intended to Administration, 5600 Fishers Lane,

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60682 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices

Rockville, MD 20857; or the Office of severe DILI. An increased rate of of Dockets Management between 9 a.m.
Communication, Training, and elevated aminotransferase (AT) levels and 4 p.m., Monday through Friday.
Manufacturers Assistance (HFM–40), compared to control is a highly sensitive
IV. Electronic Access
Center for Biologics Evaluation and indicator of potential severe
Research, 1401 Rockville Pike, hepatotoxicity, but many drugs that do Persons with access to the Internet
Rockville, MD 20852–1448. The draft not cause severe injury show AT may obtain the document at http://
guidance may also be obtained from the elevations, so the specificity of this test www.fda.gov/cder/guidance/index.htm,
Center for Biologics Evaluation and as a predictor of a potential for severe http://www.fda.gov/cber/
Research by mail by calling 1–800–835– hepatotoxicity is poor. Specificity is guidelines.htm, or http://www.fda.gov/
4709 or 301–827–1800. Send one self- increased when the signal used is the ohrms/dockets/default.htm.
addressed adhesive label to assist that occurrence of more marked AT Dated: October 19, 2007.
office in processing your requests. elevation (to 5-, 10-, 20xULN), but the Jeffrey Shuren,
Submit written comments on the draft most specific finding to date is an
Assistant Commissioner for Policy.
guidance to the Division of Dockets overall pattern of AT elevation together
[FR Doc. E7–21060 Filed 10–24–07; 8:45 am]
Management (HFA–305), Food and Drug with elevated bilirubin (and no
Administration, 5630 Fishers Lane, rm. evidence of bile obstruction) in a small
1061, Rockville, MD 20852. Submit number of subjects.
electronic comments to http:// This guidance describes the
sensitivity and specificity of various DEPARTMENT OF HEALTH AND
www.fda.gov/dockets/ecomments or HUMAN SERVICES
http://www.regulations.gov. See the indicators of hepatotoxic potential, as
SUPPLEMENTARY INFORMATION section for well as the observations needed to Food and Drug Administration
electronic access to the draft guidance evaluate those indicators, including
document. detection, confirmation, and monitoring [Docket No. 2007D–0387]
of liver test abnormalities, close
FOR FURTHER INFORMATION CONTACT: evaluation and exclusion of other Draft Guidance for Industry and Food
Tom Moreno, Center for Drug causes, and careful supportive care and and Drug Administration Staff; In Vitro
Evaluation and Research, Food and followup to normality or return to Diagnostic Device Studies—Frequently
Drug Administration, 10903 New baseline status. Asked Questions; Availability
Hampshire Ave., Bldg. 22, rm. 5143, This draft guidance is being issued
Silver Spring, MD 20993–0002, AGENCY: Food and Drug Administration,
consistent with FDA’s good guidance HHS.
301–796–0878; or practices regulation (21 CFR 10.115).
Bruce Schneider, Center for Biologics ACTION: Notice.
The draft guidance, when finalized, will
Evaluation and Research (HFM– represent the agency’s current thinking SUMMARY: The Food and Drug
755), Food and Drug on premarketing clinical evaluation of Administration (FDA) is announcing the
Administration, 1401 Rockville drug-induced liver injury. It does not availability of the draft guidance
Pike, Rockville, MD 20852, 301– create or confer any rights for or on any entitled ‘‘Draft Guidance for Industry
827–5102. person and does not operate to bind and FDA Staff; In Vitro Diagnostic (IVD)
SUPPLEMENTARY INFORMATION: FDA or the public. An alternative Device Studies—Frequently Asked
I. Background approach may be used if such approach Questions.’’ This draft guidance
satisfies the requirements of the document contains information to assist
FDA is announcing the availability of applicable statutes and regulations. manufacturers in developing and
a draft guidance for industry entitled
II. The Paperwork Reduction Act of conducting studies for IVD devices,
‘‘Drug-Induced Liver Injury:
1995 particularly those exempt from most of
Premarketing Clinical Evaluation.’’
the Investigational Device Exemption
Idiosyncratic hepatotoxicity is an This guidance refers to previously (IDE) regulations. This draft guidance is
important cause of drug withdrawal and approved collections of information that neither final nor is it in effect at this
has led to considerable FDA attention to are subject to review by the Office of time.
the subject, beginning with a conference Management and Budget (OMB) under
on hepatotoxicity at the National the Paperwork Reduction Act of 1995 DATES: Although you can comment on
Institutes of Health in 1978. The science (44 U.S.C. 3501–3520). The collections any guidance at any time (see 21 CFR
of detecting and evaluating DILI during of information in 21 CFR parts 312, 314, 10.115)(g)(5)), to ensure that the agency
drug development is evolving, and FDA and 600 have been approved under considers your comment on this draft
is working with industry, academia, and OMB control numbers 0910–0014, before it begins work on the final
other government groups toward better 0910–0001, and 0910–0338, version of the guidance, submit written
understanding of the problems and what respectively. or electronic comments on the draft
to do about them. guidance by January 23, 2008.
Even drugs that prove to be significant III. Comments ADDRESSES: Submit written requests for
hepatotoxins (e.g, bromfenac and Interested persons may submit to the single copies of the draft guidance
troglitazone) are unlikely to show cases Division of Dockets Management (see document entitled ‘‘Draft Guidance for
of severe DILI during a drug ADDRESSES) written or electronic Industry and FDA Staff; In Vitro
development program with at most comments regarding this document. Diagnostic (IVD) Device Studies—
several thousand exposed subjects. Submit a single copy of electronic Frequently Asked Questions’’ to the
Therefore, it is critical during drug comments or two paper copies of any Division of Small Manufacturers,
mstockstill on PROD1PC66 with NOTICES

development to discover less severe mailed comments, except that International, and Consumer Assistance
DILI that may indicate a potential for individuals may submit one paper copy. (HFZ–220), Center for Devices and
the drug to cause severe DILI. There are Comments are to be identified with the Radiological Health, Food and Drug
a number of signals of liver injury that docket number found in brackets in the Administration, 1350 Piccard Dr.,
have varying levels of sensitivity and heading of this document. Received Rockville, MD 20850. Send one self-
specificity in predicting potential for comments may be seen in the Division addressed adhesive label to assist that

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