[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Notices]
[Pages 51419-51420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry and review staff entitled 
``Formal Dispute Resolution: Sponsor Appeals Above the Division 
Level.'' This guidance provides recommendations for industry and review 
staff 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/or medical disputes between CDER or CBER and 
sponsors that cannot be resolved at the division level. This guidance 
describes the formal dispute resolution procedures for sponsors that 
wish to appeal a scientific and/or medical issue to the office or 
center level and provides a structured process for resolving disputes. 
This guidance finalizes the revised draft guidance entitled ``Formal 
Dispute Resolution: Appeals Above the Division Level'' issued September 
9, 2015, and replaces the guidance of the same name issued February 
2000.

DATES: The announcement of the guidance is published in the Federal 
Register on November 6, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:

[[Page 51420]]

    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-0221 for ``Formal Dispute Resolution: Sponsor Appeals Above 
the Division Level; Guidance for Industry and Review Staff; 
Availability.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CDR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 the 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Khushboo Sharma, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6486, 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 guidance for industry and 
review staff entitled ``Formal Dispute Resolution: Sponsor Appeals 
Above the Division Level.'' During the course of review of an 
investigational new drug application, new drug application, biologics 
license application, or abbreviated new drug application, a wide 
variety of important scientific and/or medical issues are considered 
that are central to product development. 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 to have procedures in place to help ensure open and 
prompt discussion. The procedures and policies described in this 
guidance are intended to promote rapid and fair resolution of 
scientific and/or medical disputes between a sponsor and CDER or CBER.
    This guidance finalizes the revised draft guidance entitled 
``Formal Dispute Resolution: Appeals Above the Division Level'' issued 
September 9, 2015, and replaces the guidance of the same name issued 
February 2000. Based on the docket comments for the revised draft 
guidance, FDA made clarifications to this guidance. The guidance was 
also clarified to reflect that it describes the formal dispute 
resolution procedures only for sponsors that wish to appeal a 
scientific and/or medical issue regarding their applications regulated 
by CDER or CBER and does not apply to other individuals or entities. In 
addition, the guidance was updated to reflect the changes under the 
2017 reauthorization of the Generic Drug User Fee Amendments of 2012 
(GDUFA) regarding timelines for reviewing disputes involving drug 
applications covered by GDUFA.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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. This guidance is not subject to Executive 
Order 12866.

II. The Paperwork Reduction Act of 1995

    This 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 guidance have been 
approved under OMB control number 0910-0430. This guidance finalizes a 
revision of an earlier version of the guidance. This version contains 
no additional information collections; therefore, it continues to be 
covered under OMB control number 0910-0430.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/default.htm, https://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/default.htm, or https://www.regulations.gov.

    Dated: October 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24096 Filed 11-3-17; 8:45 am]
 BILLING CODE 4164-01-P