[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15955-15956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05721]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0221]
Draft Guidance for Industry and Review Staff on Formal Dispute
Resolution: Appeals Above the Division Level; 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availability of a draft guidance for industry and review staff entitled
``Formal Dispute Resolution: Appeals Above the Division Level.'' This
guidance is intended to provide recommendations for industry on the
procedures in the Center for Drug Evaluation and Research (CDER) and
the Center for Biologics Evaluation and Research (CBER) for resolving
scientific and procedural disputes that cannot be resolved at the
division level. This guidance describes procedures for formally
appealing such disputes to the office or center level and providing
information to assist FDA officials in resolving the issue(s)
presented. This guidance revises the guidance of the same name issued
in February 2000.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 11, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
requests. The draft guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance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Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Amy Bertha, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6469, Silver Spring, MD 20993-0002, 301-796-0700; or,
Sheryl Lard-Whiteford, Center for Biologics Evaluation and Research
(HFM-4), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448, 301-827-0379.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and review staff entitled ``Formal Dispute Resolution: Appeals Above
the Division Level.'' In the course of drug review, CDER and CBER make
a wide variety of scientific and procedural decisions that are critical
to a sponsor's drug development program. Sometimes, a
[[Page 15956]]
sponsor may disagree with one of these decisions, and a dispute arises.
Because these disputes often involve complex scientific or procedural
matters and also may be precedent setting, it is critical that there be
procedures in place to encourage open, prompt discussion of such
disputes. The procedures and policies described in this guidance are
intended to promote rapid resolution of scientific and procedural
disputes between sponsors and FDA. This draft guidance is a revision of
the guidance of the same name that published in February 2000. The
procedures and policies have been updated to reflect the current
practices.
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 formal
dispute resolution regarding appeals above the division level. 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 found in FDA regulations. These collections of information
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 this draft guidance have been approved
under OMB control number 0910-0430. This draft guidance is a revision
of an earlier version of the guidance. The revised version contains no
additional information collections; therefore, it continues to be
covered under OMB control number 0910-0430.
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
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.
Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05721 Filed 3-12-13; 8:45 am]
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