80 FR 54296 - Formal Dispute Resolution: Appeals Above the Division Level; Revised Draft Guidance for Industry and Review Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 174 (September 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 174 (September 9, 2015)
| Page Range | 54296-54297 | |
| FR Document | 2015-22678 |
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)] [Notices] [Pages 54296-54297] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22678] ----------------------------------------------------------------------- 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Drug Administration [Docket No. FDA-2013-D-0221] Formal Dispute Resolution: Appeals Above the Division Level; Revised Draft Guidance for Industry and Review Staff; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry and review staff entitled ``Formal Dispute Resolution: Appeals Above the Division Level.''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 This draft guidance revises the draft guidance of the same name issued March 13, 2013.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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this revised draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 8, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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] BILLING CODE 4164-01-P
![54296 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
unintentional and adverse. The standard Dated: September 3, 2015. to assist that office in processing your
comprehensive test battery is generally Leslie Kux, requests. See the SUPPLEMENTARY
sufficient to identify endocrine-related Associate Commissioner for Policy. INFORMATION section for electronic
toxicity. Depending on the outcome of [FR Doc. 2015–22683 Filed 9–8–15; 8:45 am] access to the draft guidance document.
a standard battery of nonclinical tests, BILLING CODE 4164–01–P
Submit electronic comments on the
additional nonclinical studies may be revised draft guidance to http://
warranted to more fully characterize the www.regulations.gov. Submit written
endocrine-related toxicity potential of a DEPARTMENT OF HEALTH AND comments to the Division of Dockets
drug. HUMAN SERVICES Management (HFA–305), Food and Drug
This guidance finalizes the draft Administration, 5630 Fishers Lane, Rm.
guidance entitled ‘‘Endocrine Food and Drug Administration 1061, Rockville, MD 20852.
Disruption Potential of Drugs: [Docket No. FDA–2013–D–0221] FOR FURTHER INFORMATION CONTACT:
Nonclinical Evaluation’’ issued on Khushboo Sharma, Center for Drug
September 20, 2013 (78 FR 57859). Formal Dispute Resolution: Appeals Evaluation and Research, Food and
Revisions to the draft guidance address Above the Division Level; Revised Drug Administration, 10903 New
public comments and try to give more Draft Guidance for Industry and Hampshire Ave., Bldg. 22, Rm. 6468,
clarity regarding when additional Review Staff; Availability Silver Spring, MD 20993–0002, 301–
studies could be appropriate. 796–0700; or Stephen Ripley, Center for
AGENCY: Food and Drug Administration, Biologics Evaluation and Research,
This guidance is being issued HHS.
consistent with FDA’s good guidance Food and Drug Administration, 10903
ACTION: Notice. New Hampshire Ave., Bldg. 71, Rm.
practices regulation (21 CFR 10.115).
The guidance represents the current SUMMARY: The Food and Drug 7301, Silver Spring, MD 20993–0002,
thinking of FDA on nonclinical Administration (FDA or Agency) is 240–402–7911.
evaluation of endocrine-related drug announcing the availability of a revised SUPPLEMENTARY INFORMATION:
toxicity. It does not establish any rights draft guidance for industry and review I. Background
for any person and is not binding on staff entitled ‘‘Formal Dispute
FDA or the public. You can use an Resolution: Appeals Above the Division FDA is announcing the availability of
alternative approach if it satisfies the Level.’’ This guidance is intended to a revised draft guidance for industry
requirements of the applicable statutes provide recommendations for industry and review staff entitled ‘‘Formal
and regulations. and review staff on the procedures in Dispute Resolution: Appeals Above the
the Center for Drug Evaluation and Division Level.’’ In the course of the
II. The Paperwork Reduction Act of Research (CDER) and Center for review of applications for user fee
1995 Biologics Evaluation and Research products, a wide variety of scientific
(CBER) for resolving scientific and/or and/or medical issues are discussed that
This guidance refers to previously are critical to a sponsor’s drug product
approved collections of information that medical disputes that cannot be
resolved at the division level. This development program. Sometimes, a
are subject to review by the Office of sponsor may disagree with the Agency
Management and Budget (OMB) under guidance describes procedures for
formally appealing such disputes to the on a matter, and a dispute arises.
the Paperwork Reduction Act of 1995 Because these disputes often involve
(44 U.S.C. 3501–3520). The collections office or center level and providing
information to assist FDA officials in complex scientific and/or medical
of information in 21 CFR parts 312 and matters, it is critical that there be
314 have been approved under OMB resolving the issue(s) presented. This
draft guidance revises the draft guidance procedures in place to help ensure
control numbers 0910–0014 and 0910– open, prompt discussion of such
0001, respectively. of the same name issued March 13,
2013. disputes. The procedures and policies
III. Comments described in this guidance are intended
DATES: Although you can comment on to promote rapid resolution of scientific
Interested persons may submit either any guidance at any time (see 21 CFR and/or medical disputes between
electronic comments regarding this 10.115(g)(5)), to ensure that the Agency sponsors and CDER or CBER.
document to http://www.regulations.gov considers your comment on this revised This draft guidance revises the draft
or written comments to the Division of draft guidance before it begins work on guidance of the same name issued
Dockets Management (see ADDRESSES). It the final version of the guidance, submit March 13, 2013 (78 FR 15955). Based on
is only necessary to send one set of either electronic or written comments the docket comments for the draft
comments. Identify comments with the on the draft guidance by December 8, guidance as well as on its own
docket number found in brackets in the 2015. initiative, FDA made the following
heading of this document. Received ADDRESSES: Submit written requests for changes. The scope of the guidance was
comments may be seen in the Division single copies of the draft guidance to the expanded to include formal dispute
of Dockets Management between 9 a.m. Division of Drug Information, Center for resolution requests for human drug
and 4 p.m., Monday through Friday, and Drug Evaluation and Research, Food applications covered under the
will be posted to the docket at http:// and Drug Administration, 10001 New Biosimilar User Fee Act of 2012.
www.regulations.gov. Hampshire Ave., Hillandale Building, Additionally, certain areas were revised
IV. Electronic Access 4th Floor, Silver Spring, MD 20993– to provide more clarity, such as when a
Lhorne on DSK5TPTVN1PROD with NOTICES
0002, or Office of Communication, matter is and is not appropriate for a
Persons with access to the Internet Outreach, and Development, Center for formal dispute resolution request, and
may obtain the document at either Biologics Evaluation and Research, information to include in the supporting
http://www.fda.gov/Drugs/Guidance Food and Drug Administration, 10903 background information. Also, this
ComplianceRegulatoryInformation/ New Hampshire Ave., Bldg. 71, Rm. guidance clarifies that CDER and CBER
Guidances/default.htm or http:// 3128, Silver Spring, MD 20993–0002. intend to manage formal requests for
www.regulations.gov. Send one self-addressed adhesive label appeals of scientific and/or medical
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![Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 54297
disputes related to an application for a Dated: September 2, 2015. and devices (21 CFR 312.50 and 312.56
user fee product under any of the Leslie Kux, for drugs and biologics and 21 CFR
available regulatory mechanisms (i.e., Associate Commissioner for Policy. 812.40 and 812.46 for devices). Various
21 CFR 10.75, 312.48(c), 314.103(c)), [FR Doc. 2015–22678 Filed 9–8–15; 8:45 am] individuals and groups play different
through the formal dispute resolution BILLING CODE 4164–01–P roles in clinical trial monitoring. One
process. such group is a data monitoring
committee (DMC), appointed by a
This revised draft guidance is being
DEPARTMENT OF HEALTH AND sponsor to evaluate the accumulating
issued consistent with FDA’s good outcome data in some trials. A clinical
HUMAN SERVICES
guidance practices regulation (21 CFR trial DMC is a group of individuals with
10.115). The draft guidance, when Food and Drug Administration pertinent expertise that reviews on a
finalized, will represent the current regular basis accumulating data from
[Docket No. FDA–2011–N–0908]
thinking of FDA on formal dispute one or more ongoing clinical trials. The
resolution requests for appeals above Agency Information Collection DMC advises the sponsor regarding the
the division level. It does not establish Activities; Submission for Office of continuing safety of current trial
any rights for any person and is not Management and Budget Review; subjects and those yet to be recruited to
binding on FDA or the public. You can Comment Request; Guidance for the trial, as well as the continuing
use an alternative approach if it satisfies Clinical Trial Sponsors: Establishment validity and scientific merit of the trial.
the requirements of the applicable and Operation of Clinical Trial Data The guidance document referenced in
statutes and regulations. Monitoring Committees this document is intended to assist
AGENCY: Food and Drug Administration, sponsors of clinical trials in determining
II. The Paperwork Reduction Act of
HHS. when a DMC is needed for monitoring
1995
a study, and how such committees
ACTION: Notice.
This revised draft guidance refers to should operate. The guidance addresses
previously approved collections of SUMMARY: The Food and Drug the roles, responsibilities, and operating
information that are subject to review by Administration (FDA) is announcing procedures of DMCs, describes certain
the Office of Management and Budget that a proposed collection of reporting and recordkeeping
(OMB) under the Paperwork Reduction information has been submitted to the responsibilities, including the
Office of Management and Budget following: (1) Sponsor reporting to FDA
Act of 1995 (44 U.S.C. 3501–3520). The
(OMB) for review and clearance under on DMC recommendations related to
collections of information in this draft
the Paperwork Reduction Act of 1995. safety; (2) standard operating
guidance have been approved under procedures (SOPs) for DMCs; (3) DMC
OMB control number 0910–0430. This DATES: Fax written comments on the
collection of information by October 9, meeting records; (4) sponsor notification
draft guidance is a revision of an earlier to the DMC regarding waivers; and (5)
2015.
version of the guidance. The revised DMC reports based on meeting minutes
ADDRESSES: To ensure that comments on
version contains no additional to the sponsor.
information collections; therefore, it the information collection are received,
OMB recommends that written 1. Sponsor Reporting to FDA on DMC
continues to be covered under OMB
comments be faxed to the Office of Recommendations Related to Safety
control number 0910–0430.
Information and Regulatory Affairs,
III. Comments OMB, Attn: FDA Desk Officer, FAX: The requirement of the sponsor to
202–395–7285, or emailed to oira_ report DMC recommendations related to
Interested persons may submit either submission@omb.eop.gov. All serious adverse events in an expedited
electronic comments regarding this comments should be identified with the manner in clinical trials of new drugs
document to http://www.regulations.gov OMB control number 0910–0581. Also (21 CFR 312.32(c)) would not apply
or written comments to the Division of include the FDA docket number found when the DMC recommendation is
Dockets Management (see ADDRESSES). It in brackets in the heading of this related to an excess of events not
is only necessary to send one set of document. classifiable as serious. Nevertheless, the
comments. Identify comments with the Agency recommends in the guidance
FOR FURTHER INFORMATION CONTACT: FDA
docket number found in brackets in the that sponsors inform FDA about all
PRA Staff, Office of Operations, Food recommendations related to the safety of
heading of this document. Received and Drug Administration, 8455 the investigational product whether or
comments may be seen in the Division Colesville Rd., COLE–14526, Silver not the adverse event in question meets
of Dockets Management between 9 a.m. Spring, MD 20993–0002, PRAStaff@ the definition of ‘‘serious.’’
and 4 p.m., Monday through Friday, and fda.hhs.gov.
will be posted to the docket at http:// SUPPLEMENTARY INFORMATION: In
2. SOPs for DMCs
www.regulations.gov. compliance with 44 U.S.C. 3507, FDA In the guidance, FDA recommends
IV. Electronic Access has submitted the following proposed that sponsors establish procedures to do
collection of information to OMB for the following things:
Persons with access to the Internet review and clearance. • Assess potential conflicts of interest
may obtain the document at http:// Guidance for Clinical Trial Sponsors: of proposed DMC members;
www.fda.gov/Drugs/ Establishment and Operation of • Ensure that those with serious
Lhorne on DSK5TPTVN1PROD with NOTICES
GuidanceCompliance Clinical Trial Data Monitoring conflicts of interest are not included in
RegulatoryInformation/Guidances/ Committees the DMC;
default.htm, http://www.fda.gov/ • Provide disclosure to all DMC
BiologicsBloodVaccines/ OMB Control Number 0910–0581— members of any potential conflicts that
GuidanceCompliance Extension are not thought to impede objectivity
RegulatoryInformation/default.htm, or Sponsors are required to monitor and, thus, would not preclude service
http://www.regulations.gov. studies evaluating new drugs, biologics, on the DMC;
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Document Created: 2015-12-15 09:53:19
Document Modified: 2015-12-15 09:53:19
| 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. | |
| 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. | |
| 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. | |
| FR Citation | 80 FR 54296 |
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