[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12759-12760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04196]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-D-0282; formerly 2005D-0183]
Draft Guidance for Industry on Attachment to Guidance on
Antiviral Product Development--Conducting and Submitting Virology
Studies to the Agency: Guidance for Submitting Hepatitis C Virus
Resistance Data; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Attachment to
Guidance on Antiviral Product Development--Conducting and Submitting
Virology Studies to the Agency: Guidance for Submitting HCV Resistance
Data.'' The purpose of this attachment is to assist sponsors in
submitting hepatitis C virus (HCV) clinical virology data, which are
important for supporting clinical trials of products in development for
the treatment of HCV. HCV resistance data submitted in appropriately
formatted datasets is a critical component in the review of
investigational antiviral products for the treatment of HCV. The
information in this attachment will facilitate the development and
regulatory review of anti-HCV products.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 26, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY
[[Page 12760]]
INFORMATION section for electronic access to the draft guidance
document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lisa K. Naeger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-0771.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Attachment to Guidance on Antiviral Product Development--
Conducting and Submitting Virology Studies to the Agency: Guidance for
Submitting HCV Resistance Data.'' The purpose of this attachment is to
assist sponsors in submitting HCV clinical virology data, which are
important for supporting clinical trials of products in development for
the treatment of HCV. This attachment revises and replaces the
attachment on submitting HCV resistance data published in June 2006 and
represents FDA's current thinking regarding how sponsors should submit
HCV resistance data. The revised attachment provides the format,
recommended definitions, standardization of column headings and
variables, and recommended data for submission of HCV resistance
datasets.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on submitting
HCV clinical virology data. 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. The Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014.
III. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04196 Filed 2-22-13; 8:45 am]
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