[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15955-15956]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry and Review Staff on Formal Dispute 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availability of a draft guidance for industry and review staff entitled 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 11, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 The draft guidance may also be obtained by mail by calling 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INFORMATION section for electronic access to the draft guidance 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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]
BILLING CODE 4160-01-P