82 FR 51419 - Formal Dispute Resolution: Sponsor Appeals Above the Division Level; Guidance for Industry and Review Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 213 (November 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 213 (November 6, 2017)
| Page Range | 51419-51420 | |
| FR Document | 2017-24096 |
[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)] [Notices] [Pages 51419-51420] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24096] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 This guidance finalizes the revised draft guidance entitled ``Formal Dispute Resolution: Appeals Above the Division Level'' issued September 9, 2015, and replaces the guidance of the same name issued February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: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. 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]] 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. 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. 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.thefederalregister.org/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
![Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51419
‘‘outcomes’’ and ‘‘outputs’’ if I don’t know Native Language Esther Martinez announcing the availability of a
what they mean to you? Or are they the same Immersion programs will align reporting guidance for industry and review staff
meaning to you and it’s just a change in the requirements to reduce the number of entitled ‘‘Formal Dispute Resolution:
words that are going to be used?
required federal financial reports, Sponsor Appeals Above the Division
Response: ANA’s intent is to provide thereby reducing the reporting burden Level.’’ This guidance provides
more universally accepted terminology, for grantees. In addition, an earlier start recommendations for industry and
especially for evaluation requirements date will provide projects with review staff on the procedures in the
and criteria. Definitions and examples additional time for planning and start Center for Drug Evaluation and Research
of all new terms will be provided in up prior to the start of the school year, (CDER) and the Center for Biologics
each of the FY 2018 FOAs. Any new which marks the beginning of Evaluation and Research (CBER) for
terminology will be addressed in instruction for many Native Language resolving scientific and/or medical
Section I. Program Description of the projects. Therefore, ANA intends to disputes between CDER or CBER and
FOA. ANA will explain each term and implement a July 1 start date for all sponsors that cannot be resolved at the
include examples of each. Definitions projects funded under the Native division level. This guidance describes
will be included in the appendix of each Language Preservation and Maintenance the formal dispute resolution
FOA. and Native Language Esther Martinez procedures for sponsors that wish to
B. ANA Administrative Policy Immersion FOAs for FY 2018. appeal a scientific and/or medical issue
Regarding Prioritized Funding for to the office or center level and provides
D. Application Period Notification
Local, Community-Based, Native a structured process for resolving
ANA would like to notify potential disputes. This guidance finalizes the
American Organizations as Described
applicants that the open application revised draft guidance entitled ‘‘Formal
in the August 14, 2017, NOPC (82 FR
period to respond to FOAs has been Dispute Resolution: Appeals Above the
37861)
updated to a minimum of 60 days to Division Level’’ issued September 9,
ANA has edited the description of support the timely award of new grants. 2015, and replaces the guidance of the
this policy since it was published in the same name issued February 2000.
Federal Register, to further clarify the E. Funding Opportunity
Announcements DATES: The announcement of the
requirements for non-local, national,
For information on the types of guidance is published in the Federal
and regional organizations. If approved,
projects funded by ANA, please refer to Register on November 6, 2017.
ANA intends to include this policy in
all FY 2018 FOAs as stated below: ANA’s Web site for information on our ADDRESSES: You may submit either
Prioritized Funding for Community- program areas and FOAs: https:// electronic or written comments on
based Native American Organizations: www.acf.hhs.gov/programs/ana. Pre- Agency guidances at any time as
publication information on ANA’s FOAs follows:
ANA reserves the right to prioritize
funding to community-based Native will be available at https:// Electronic Submissions
American organizations serving their local www.grants.gov/web/grants/search-
communities and populations. Applications grants.html by clicking on ‘Forecasted’’ Submit electronic comments in the
from non-local, national, and regional under Opportunity Status and following way:
organizations that propose projects to serve ‘‘Administration for Children and • Federal eRulemaking Portal:
multiple communities, or to be performed in https://www.regulations.gov. Follow the
a different geographic location, must clearly
Families—ANA [HHS–ACF–ANA]’’ on
the left side of the page. Synopses and instructions for submitting comments.
demonstrate that the need for the project was Comments submitted electronically,
originated by the each community being application forms will be available on
served, and that the community and/or tribal www.Grants.gov. including attachments, to https://
government supports the proposed project. www.regulations.gov will be posted to
They must also describe how each Stacey Ecoffey, the docket unchanged. Because your
community was selected, identify and Acting Commissioner, Administration for comment will be made public, you are
describe the intended beneficiaries, Native American, ACF, Acting Deputy solely responsible for ensuring that your
demonstrate community involvement in the Assistant Secretary for Native American comment does not include any
development of the project, and discuss a Affairs, Department of Health and Human confidential information that you or a
community-based delivery strategy for the Services.
third party may not wish to be posted,
project. The proposed project goals, [FR Doc. 2017–24124 Filed 11–3–17; 8:45 am]
such as medical information, your or
objectives, and outcomes must address goals BILLING CODE 4184–34–P
of the community being served. National and anyone else’s Social Security number, or
regional organizations must describe their confidential business information, such
membership, and define how the as a manufacturing process. Please note
organization operates. The type of
DEPARTMENT OF HEALTH AND that if you include your name, contact
community to be served will determine the HUMAN SERVICES information, or other information that
type of documentation necessary to support identifies you in the body of your
the project. Food and Drug Administration
comments, that information will be
[Docket No. FDA–2013–D–0221] posted on https://www.regulations.gov.
C. Additional Information Regarding • If you want to submit a comment
Project Start Dates for Language Formal Dispute Resolution: Sponsor with confidential information that you
Preservation and Maintenance, and Appeals Above the Division Level; do not wish to be made available to the
Native Language Esther Martinez Guidance for Industry and Review
Pmangrum on DSK3GDR082PROD with NOTICES
public, submit the comment as a
Immersion Grants Staff; Availability written/paper submission and in the
Through continued discussions with AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
ANA grantees and stakeholders, ANA HHS. Submissions’’ and ‘‘Instructions’’).
has determined that moving the start ACTION: Notice of availability.
date from August 1 to July 1 for projects Written/Paper Submissions
funded under the Native Language SUMMARY: The Food and Drug Submit written/paper submissions as
Preservation and Maintenance and the Administration (FDA or Agency) is follows:
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![51420 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts issued February 2000. Based on the
written/paper submissions): Dockets and/or go to the Dockets Management docket comments for the revised draft
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, guidance, FDA made clarifications to
Drug Administration, 5630 Fishers Rockville, MD 20852. this guidance. The guidance was also
Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any clarified to reflect that it describes the
• For written/paper comments guidance at any time (see 21 CDR formal dispute resolution procedures
submitted to the Dockets Management 10.115(g)(5)). only for sponsors that wish to appeal a
Staff, FDA will post your comment, as Submit written requests for single scientific and/or medical issue
well as any attachments, except for copies of this guidance to the Division regarding their applications regulated by
information submitted, marked and of Drug Information, Center for Drug CDER or CBER and does not apply to
identified, as confidential, if submitted Evaluation and Research, Food and other individuals or entities. In
as detailed in ‘‘Instructions.’’ Drug Administration, 10001 New addition, the guidance was updated to
Instructions: All submissions received Hampshire Ave., Hillandale Building, reflect the changes under the 2017
must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– reauthorization of the Generic Drug User
2013–D–0221 for ‘‘Formal Dispute 0002, or the Office of Communication, Fee Amendments of 2012 (GDUFA)
Resolution: Sponsor Appeals Above the Outreach, and Development, Center for regarding timelines for reviewing
Division Level; Guidance for Industry Biologics Evaluation and Research, disputes involving drug applications
and Review Staff; Availability.’’ Food and Drug Administration, 10903 covered by GDUFA.
Received comments will be placed in New Hampshire Ave., Bldg. 71, Rm.
the docket and, except for those This guidance is being issued
3128, Silver Spring, MD 20993–0002.
submitted as ‘‘Confidential consistent with FDA’s good guidance
Send one self-addressed adhesive label
Submissions,’’ publicly viewable at practices regulation (21 CFR 10.115).
to assist that office in processing your
https://www.regulations.gov or at the requests. See the SUPPLEMENTARY The guidance represents the current
Dockets Management Staff between 9 INFORMATION section for electronic
thinking of FDA on formal dispute
a.m. and 4 p.m., Monday through access to the guidance document. resolution requests for appeals above
Friday. the division level. It does not establish
FOR FURTHER INFORMATION CONTACT:
• Confidential Submissions—To any rights for any person and is not
submit a comment with confidential Khushboo Sharma, Center for Drug binding on FDA or the public. You can
information that you do not wish to be Evaluation and Research, Food and use an alternative approach if it satisfies
made publicly available, submit your Drug Administration, 10903 New the requirements of the applicable
comments only as a written/paper Hampshire Ave., Bldg. 22, Rm. 6486,
statutes and regulations. This guidance
submission. You should submit two Silver Spring, MD 20993–0002, 301–
is not subject to Executive Order 12866.
copies total. One copy will include the 796–0700; or, Stephen Ripley, Center for
information you claim to be confidential Biologics Evaluation and Research, II. The Paperwork Reduction Act of
with a heading or cover note that states Food and Drug Administration, 10903 1995
‘‘THIS DOCUMENT CONTAINS New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002, This guidance refers to previously
CONFIDENTIAL INFORMATION.’’ The
240–402–7911. approved collections of information that
Agency will review this copy, including
SUPPLEMENTARY INFORMATION:
are subject to review by the Office of
the claimed confidential information, in
Management and Budget (OMB) under
its consideration of comments. The I. Background
second copy, which will have the the Paperwork Reduction Act of 1995
claimed confidential information FDA is announcing the availability of (44 U.S.C. 3501–3520). The collections
redacted/blacked out, will be available a guidance for industry and review staff of information in this guidance have
for public viewing and posted on entitled ‘‘Formal Dispute Resolution: been approved under OMB control
https://www.regulations.gov. Submit Sponsor Appeals Above the Division number 0910–0430. This guidance
both copies to the Dockets Management Level.’’ During the course of review of finalizes a revision of an earlier version
Staff. If you do not wish your name and an investigational new drug application, of the guidance. This version contains
contact information to be made publicly new drug application, biologics license no additional information collections;
available, you can provide this application, or abbreviated new drug therefore, it continues to be covered
information on the cover sheet and not application, a wide variety of important under OMB control number 0910–0430.
in the body of your comments and you scientific and/or medical issues are III. Electronic Access
must identify this information as considered that are central to product
‘‘confidential.’’ Any information marked development. Sometimes, a sponsor Persons with access to the internet
as ‘‘confidential’’ will not be disclosed may disagree with the Agency on a may obtain the guidance at https://
except in accordance with 21 CFR 10.20 matter, and a dispute arises. Because www.fda.gov/drugs/
and other applicable disclosure law. For these disputes often involve complex guidancecompliance
more information about FDA’s posting scientific and/or medical matters, it is regulatoryinformation/guidances/
of comments to public dockets, see 80 critical to have procedures in place to default.htm, https://www.fda.gov/
FR 56469, September 18, 2015, or access help ensure open and prompt biologicsbloodvaccines/
the information at: https://www.gpo.gov/ discussion. The procedures and policies guidancecompliance
fdsys/pkg/FR-2015-09-18/pdf/2015- described in this guidance are intended regulatoryinformation/default.htm, or
Pmangrum on DSK3GDR082PROD with NOTICES
23389.pdf. to promote rapid and fair resolution of https://www.regulations.gov.
Docket: For access to the docket to scientific and/or medical disputes
Dated: October 31, 2017.
read background documents or the between a sponsor and CDER or CBER.
electronic and written/paper comments This guidance finalizes the revised Anna K. Abram,
received, go to https:// draft guidance entitled ‘‘Formal Dispute Deputy Commissioner for Policy, Planning,
www.regulations.gov and insert the Resolution: Appeals Above the Division Legislation, and Analysis.
docket number, found in brackets in the Level’’ issued September 9, 2015, and [FR Doc. 2017–24096 Filed 11–3–17; 8:45 am]
heading of this document, into the replaces the guidance of the same name BILLING CODE 4164–01–P
VerDate Sep<11>2014 14:48 Nov 03, 2017 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 9990 E:\FR\FM\06NON1.SGM 06NON1](https://thefederalregister.org/doc/82_FR_51632/page/2.svg)
Document Created: 2017-11-07 10:30:36
Document Modified: 2017-11-07 10:30:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on November 6, 2017. | |
| 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. | |
| FR Citation | 82 FR 51419 |
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