Formal Dispute Resolution: Appeals Above the Division Level; Revised Draft Guidance for Industry and Review Staff; Availability, 54296-54297 [2015-22678]

Download as PDF 54296 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices unintentional and adverse. The standard comprehensive test battery is generally sufficient to identify endocrine-related toxicity. Depending on the outcome of a standard battery of nonclinical tests, additional nonclinical studies may be warranted to more fully characterize the endocrine-related toxicity potential of a drug. This guidance finalizes the draft guidance entitled ‘‘Endocrine Disruption Potential of Drugs: Nonclinical Evaluation’’ issued on September 20, 2013 (78 FR 57859). Revisions to the draft guidance address public comments and try to give more clarity regarding when additional studies could be appropriate. 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 nonclinical evaluation of endocrine-related drug toxicity. 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 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 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. III. Comments Lhorne on DSK5TPTVN1PROD with NOTICES 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 either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 Dated: September 3, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–22683 Filed 9–8–15; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 E:\FR\FM\09SEN1.SGM 09SEN1 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 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. Dated: September 2, 2015. Leslie Kux, Associate Commissioner for Policy. II. The Paperwork Reduction Act of 1995 AGENCY: 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. Lhorne on DSK5TPTVN1PROD with NOTICES IV. Electronic Access Persons with access to the Internet may obtain the document at http:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, http://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm, or http://www.regulations.gov. 14:19 Sep 08, 2015 Jkt 235001 BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0908] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Food and Drug Administration, HHS. 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. VerDate Sep<11>2014 [FR Doc. 2015–22678 Filed 9–8–15; 8:45 am] ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by October 9, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0581. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees OMB Control Number 0910–0581— Extension Sponsors are required to monitor studies evaluating new drugs, biologics, PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 54297 and devices (21 CFR 312.50 and 312.56 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices). Various individuals and groups play different roles in clinical trial monitoring. One such group is a data monitoring committee (DMC), appointed by a sponsor to evaluate the accumulating outcome data in some trials. A clinical trial DMC is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DMC advises the sponsor regarding the continuing safety of current trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial. The guidance document referenced in this document is intended to assist sponsors of clinical trials in determining when a DMC is needed for monitoring a study, and how such committees should operate. The guidance addresses the roles, responsibilities, and operating procedures of DMCs, describes certain reporting and recordkeeping responsibilities, including the following: (1) Sponsor reporting to FDA on DMC recommendations related to safety; (2) standard operating procedures (SOPs) for DMCs; (3) DMC meeting records; (4) sponsor notification to the DMC regarding waivers; and (5) DMC reports based on meeting minutes to the sponsor. 1. Sponsor Reporting to FDA on DMC Recommendations Related to Safety The requirement of the sponsor to report DMC recommendations related to serious adverse events in an expedited manner in clinical trials of new drugs (21 CFR 312.32(c)) would not apply when the DMC recommendation is related to an excess of events not classifiable as serious. Nevertheless, the Agency recommends in the guidance that sponsors inform FDA about all recommendations related to the safety of the investigational product whether or not the adverse event in question meets the definition of ‘‘serious.’’ 2. SOPs for DMCs In the guidance, FDA recommends that sponsors establish procedures to do the following things: • Assess potential conflicts of interest of proposed DMC members; • Ensure that those with serious conflicts of interest are not included in the DMC; • Provide disclosure to all DMC members of any potential conflicts that are not thought to impede objectivity and, thus, would not preclude service on the DMC; E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[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.

-----------------------------------------------------------------------

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