[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54296-54297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0221]


Formal Dispute Resolution: Appeals Above the Division Level; 
Revised Draft Guidance for Industry and Review Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a revised draft guidance for industry and review 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 and review staff on the procedures in the Center for Drug 
Evaluation and Research (CDER) and Center for Biologics Evaluation and 
Research (CBER) for resolving scientific and/or medical 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 This draft guidance revises the draft guidance 
of the same name issued March 13, 2013.

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 
revised draft guidance before it begins work on the final version of 
the guidance, submit either electronic or written comments on the draft 
guidance by December 8, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002, or Office of Communication, Outreach, and Development, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit electronic comments on the revised draft guidance to http://www.regulations.gov.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: Khushboo Sharma, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6468, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry and review staff entitled ``Formal Dispute Resolution: Appeals 
Above the Division Level.'' In the course of the review of applications 
for user fee products, a wide variety of scientific and/or medical 
issues are discussed that are critical to a sponsor's drug product 
development program. Sometimes, a sponsor may disagree with the Agency 
on a matter, and a dispute arises. Because these disputes often involve 
complex scientific and/or medical matters, it is critical that there be 
procedures in place to help ensure open, prompt discussion of such 
disputes. The procedures and policies described in this guidance are 
intended to promote rapid resolution of scientific and/or medical 
disputes between sponsors and CDER or CBER.
    This draft guidance revises the draft guidance of the same name 
issued March 13, 2013 (78 FR 15955). Based on the docket comments for 
the draft guidance as well as on its own initiative, FDA made the 
following changes. The scope of the guidance was expanded to include 
formal dispute resolution requests for human drug applications covered 
under the Biosimilar User Fee Act of 2012. Additionally, certain areas 
were revised to provide more clarity, such as when a matter is and is 
not appropriate for a formal dispute resolution request, and 
information to include in the supporting background information. Also, 
this guidance clarifies that CDER and CBER intend to manage formal 
requests for appeals of scientific and/or medical

[[Page 54297]]

disputes related to an application for a user fee product under any of 
the available regulatory mechanisms (i.e., 21 CFR 10.75, 312.48(c), 
314.103(c)), through the formal dispute resolution process.
    This revised 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 current thinking of FDA on formal 
dispute resolution requests for appeals above the division level. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This revised 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 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: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22678 Filed 9-8-15; 8:45 am]
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