80_FR_76740 80 FR 76504 - Best Practices for Communication Between Investigational New Drug Sponsors and Food and Drug Administration During Drug Development; Draft Guidance for Industry and Review Staff; Availability

80 FR 76504 - Best Practices for Communication Between Investigational New Drug Sponsors and Food and Drug Administration During Drug Development; Draft Guidance for Industry and Review Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 236 (December 9, 2015)

Page Range76504-76505
FR Document2015-30931

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled ``Best Practices for Communication Between IND Sponsors and FDA During Drug Development.'' The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public.

Federal Register, Volume 80 Issue 236 (Wednesday, December 9, 2015) 
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76504-76505]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30931]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4380]


Best Practices for Communication Between Investigational New Drug 
Sponsors and Food and Drug Administration During Drug Development; 
Draft Guidance for Industry and Review Staff; Availability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the availability of a draft guidance for industry and review staff 
entitled ``Best Practices for Communication Between IND Sponsors and 
FDA During Drug Development.'' The purpose of this guidance is to 
describe best practices and procedures for timely, transparent, and 
effective communications between investigational new drug application 
(IND) sponsors and FDA at critical junctures in drug development, which 
may facilitate earlier availability of safe and effective drugs to the 
American public.

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 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 8, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-4380 for ``Best Practices for Communication Between IND 
Sponsors and FDA During Drug Development; Draft 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 http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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.

FOR FURTHER INFORMATION CONTACT: Rachel E. Hartford, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-0319; 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 draft guidance for industry 
and review staff entitled ``Best Practices for Communication Between 
IND Sponsors and FDA During Drug Development.'' As part of the 
Prescription Drug User Fee Amendments of 2012, described in 
``Reauthorization Performance Goals

[[Page 76505]]

and Procedures; Fiscal Years 2013 through 2017,'' the Center for Drug 
Evaluation and Research (CDER) and the Center for Biologics Evaluation 
and Research (CBER) agreed to publish a joint guidance for industry and 
review staff on best practices for communication between IND sponsors 
and FDA during drug development.
    To establish the best practices described in this guidance, CDER 
and CBER gathered the experiences of review staff and incorporated 
input from interested parties who responded to a notice published in 
the Federal Register (79 FR 64397; October 29, 2014) or who provided 
input directly to CDER's Enhanced Communication Team.
    This guidance describes FDA's philosophy regarding timely 
interactive communication with IND sponsors as a core activity; the 
scope of appropriate interactions between the review team and the 
sponsor; the types of advice appropriate for sponsors to seek from FDA 
in pursuing their drug development program; the general expectations 
for the timing of FDA response to IND sponsor inquiries; best practices 
and communication methods to facilitate interactions between the FDA 
review team and the IND sponsor during drug development; and 
expectations on appropriate methods and frequency of such 
communications. This guidance does not apply to communications or 
inquiries from industry trade organizations, consumer or patient 
advocacy organizations, other government agencies, or other 
stakeholders not pursuing a development program under an IND.
    This 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 best practices 
for communication between IND sponsors and FDA during drug development. 
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. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: December 3, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-30931 Filed 12-8-15; 8:45 am]
BILLING CODE 4164-01-P

76504 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices Dated: December 3, 2015. third party may not wish to be posted, name and contact information to be Peter Lurie, such as medical information, your or made publicly available, you can Associate Commissioner for Public Health anyone else’s Social Security number, or provide this information on the cover Strategy and Analysis. confidential business information, such sheet and not in the body of your [FR Doc. 2015–30936 Filed 12–8–15; 8:45 am] as a manufacturing process. Please note comments and you must identify this BILLING CODE 4164–01–P that if you include your name, contact information as ‘‘confidential.’’ Any information, or other information that information marked as ‘‘confidential’’ identifies you in the body of your will not be disclosed except in DEPARTMENT OF HEALTH AND comments, that information will be accordance with 21 CFR 10.20 and other HUMAN SERVICES posted on http://www.regulations.gov. applicable disclosure law. For more • If you want to submit a comment information about FDA’s posting of Food and Drug Administration with confidential information that you comments to public dockets, see 80 FR do not wish to be made available to the 56469, September 18, 2015, or access [Docket No. FDA–2015–D–4380] public, submit the comment as a the information at: http://www.fda.gov/ Best Practices for Communication written/paper submission and in the regulatoryinformation/dockets/ Between Investigational New Drug manner detailed (see ‘‘Written/Paper default.htm. Sponsors and Food and Drug Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to Administration During Drug Written/Paper Submissions read background documents or the Development; Draft Guidance for electronic and written/paper comments Submit written/paper submissions as received, go to http:// Industry and Review Staff; Availability follows: www.regulations.gov and insert the AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for docket number, found in brackets in the HHS. written/paper submissions): Division of heading of this document, into the ACTION: Notice of availability. Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts and Drug Administration, 5630 Fishers and/or go to the Division of Dockets SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments Management, 5630 Fishers Lane, Rm. Administration (FDA or Agency) is 1061, Rockville, MD 20852. announcing the availability of a draft submitted to the Division of Dockets Management, FDA will post your Submit written requests for single guidance for industry and review staff copies of the draft guidance to the entitled ‘‘Best Practices for comment, as well as any attachments, except for information submitted, Division of Drug Information, Center for Communication Between IND Sponsors Drug Evaluation and Research, Food and FDA During Drug Development.’’ marked and identified, as confidential, if submitted as detailed in and Drug Administration, 10001 New The purpose of this guidance is to Hampshire Ave., Hillandale Building, describe best practices and procedures ‘‘Instructions.’’ Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– for timely, transparent, and effective 0002, or Office of Communication, communications between must include the Docket No. FDA– 2015–D–4380 for ‘‘Best Practices for Outreach, and Development, Center for investigational new drug application Biologics Evaluation and Research, (IND) sponsors and FDA at critical Communication Between IND Sponsors and FDA During Drug Development; Food and Drug Administration, 10903 junctures in drug development, which New Hampshire Ave., Bldg. 71, Rm. may facilitate earlier availability of safe Draft Guidance for Industry and Review Staff; Availability.’’ Received comments 3128, Silver Spring, MD 20993–0002. and effective drugs to the American Send one self-addressed adhesive label public. will be placed in the docket and, except for those submitted as ‘‘Confidential to assist that office in processing your DATES: Although you can comment on Submissions,’’ publicly viewable at requests. See the SUPPLEMENTARY any guidance at any time (see 21 CFR http://www.regulations.gov or at the INFORMATION section for electronic 10.115(g)(5)), to ensure that the Agency Division of Dockets Management access to the draft guidance document. considers your comment on this draft between 9 a.m. and 4 p.m., Monday FOR FURTHER INFORMATION CONTACT: guidance before it begins work on the through Friday. Rachel E. Hartford, Center for Drug final version of the guidance, submit • Confidential Submissions—To Evaluation and Research, Food and either electronic or written comments submit a comment with confidential Drug Administration, 10903 New on the draft guidance by February 8, information that you do not wish to be Hampshire Ave., Bldg. 22, Rm. 6312, 2016. made publicly available, submit your Silver Spring, MD 20993–0002, 301– ADDRESSES: You may submit comments comments only as a written/paper 796–0319; or Stephen Ripley, Center for as follows: submission. You should submit two Biologics Evaluation and Research, copies total. One copy will include the Food and Drug Administration, 10903 Electronic Submissions information you claim to be confidential New Hampshire Ave. Bldg. 71, Rm. Submit electronic comments in the with a heading or cover note that states 7301, Silver Spring, MD 20993–0002, following way: ‘‘THIS DOCUMENT CONTAINS 240–402–7911. • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the Agency will review this copy, including instructions for submitting comments. the claimed confidential information, in I. Background mstockstill on DSK4VPTVN1PROD with NOTICES Comments submitted electronically, its consideration of comments. The FDA is announcing the availability of including attachments, to http:// second copy, which will have the a draft guidance for industry and review www.regulations.gov will be posted to claimed confidential information staff entitled ‘‘Best Practices for the docket unchanged. Because your redacted/blacked out, will be available Communication Between IND Sponsors comment will be made public, you are for public viewing and posted on http:// and FDA During Drug Development.’’ solely responsible for ensuring that your www.regulations.gov. Submit both As part of the Prescription Drug User comment does not include any copies to the Division of Dockets Fee Amendments of 2012, described in confidential information that you or a Management. If you do not wish your ‘‘Reauthorization Performance Goals VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1

Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76505 and Procedures; Fiscal Years 2013 III. Electronic Access modifications that impact a previously through 2017,’’ the Center for Drug Persons with access to the Internet announced advisory committee meeting Evaluation and Research (CDER) and the may obtain the draft guidance at http:// cannot always be published quickly Center for Biologics Evaluation and www.fda.gov/Drugs/Guidance enough to provide timely notice. Research (CBER) agreed to publish a ComplianceRegulatoryInformation/ Therefore, you should always check the joint guidance for industry and review Guidances/default.htm, http://www.fda. Agency’s Web site at http://www.fda. staff on best practices for gov/BiologicsBloodVaccines/Guidance gov/AdvisoryCommittees/default.htm communication between IND sponsors ComplianceRegulatoryInformation/ and scroll down to the appropriate and FDA during drug development. default.htm, or http:// advisory committee meeting link, or call To establish the best practices the advisory committee information line www.regulations.gov. described in this guidance, CDER and to learn about possible modifications CBER gathered the experiences of Dated: December 3, 2015. before coming to the meeting. review staff and incorporated input Peter Lurie, Agenda: The committee will discuss from interested parties who responded Associate Commissioner for Public Health new drug application (NDA) 204442, to a notice published in the Federal Strategy and Analysis. PROBUPHINE (buprenorphine Register (79 FR 64397; October 29, [FR Doc. 2015–30931 Filed 12–8–15; 8:45 am] hydrochloride and ethylene vinyl 2014) or who provided input directly to BILLING CODE 4164–01–P acetate) subdermal implant, submitted CDER’s Enhanced Communication by Braeburn Pharmaceuticals, Inc., on Team. behalf of Titan Pharmaceuticals for the This guidance describes FDA’s DEPARTMENT OF HEALTH AND proposed indication of maintenance philosophy regarding timely interactive HUMAN SERVICES treatment of opioid dependence. communication with IND sponsors as a FDA intends to make background core activity; the scope of appropriate Food and Drug Administration material available to the public no later interactions between the review team [Docket No. FDA–2015–N–0001] than 2 business days before the meeting. and the sponsor; the types of advice If FDA is unable to post the background appropriate for sponsors to seek from Psychopharmacologic Drugs Advisory material on its Web site prior to the FDA in pursuing their drug Committee; Notice of Meeting meeting, the background material will development program; the general AGENCY: Food and Drug Administration, be made publicly available at the expectations for the timing of FDA HHS. location of the advisory committee response to IND sponsor inquiries; best meeting, and the background material practices and communication methods ACTION: Notice. will be posted on FDA’s Web site after to facilitate interactions between the FDA review team and the IND sponsor This notice announces a forthcoming the meeting. Background material is during drug development; and meeting of a public advisory committee available at http://www.fda.gov/ expectations on appropriate methods of the Food and Drug Administration AdvisoryCommittees/Calendar/ and frequency of such communications. (FDA). The meeting will be open to the default.htm. Scroll down to the This guidance does not apply to public. appropriate advisory committee meeting communications or inquiries from Name of Committee: link. industry trade organizations, consumer Psychopharmacologic Drugs Advisory Procedure: Interested persons may or patient advocacy organizations, other Committee. present data, information, or views, government agencies, or other General Function of the Committee: orally or in writing, on issues pending stakeholders not pursuing a To provide advice and before the committee. Written development program under an IND. recommendations to the Agency on submissions may be made to the contact This draft guidance is being issued FDA’s regulatory issues. person on or before December 28, 2015. consistent with FDA’s good guidance Date and Time: The meeting will be Oral presentations from the public will practices regulation (21 CFR 10.115). held on January 12, 2016, from 8 a.m. be scheduled between approximately 1 The draft guidance, when finalized, will to 5 p.m. p.m. and 2 p.m. Those individuals represent the current thinking of FDA Location: FDA White Oak Campus, interested in making formal oral on best practices for communication 10903 New Hampshire Ave., Bldg. 31, presentations should notify the contact between IND sponsors and FDA during Conference Center, the Great Room (Rm. person and submit a brief statement of drug development. It does not establish 1503), Silver Spring, MD 20993–0002. the general nature of the evidence or any rights for any person and is not Answers to commonly asked questions arguments they wish to present, the binding on FDA or the public. You can including information regarding special names and addresses of proposed use an alternative approach if it satisfies accommodations due to a disability, participants, and an indication of the the requirements of the applicable visitor parking, and transportation may approximate time requested to make statutes and regulations. be accessed at: http://www.fda.gov/ their presentation on or before AdvisoryCommittees/AboutAdvisory December 17, 2015. Time allotted for II. The Paperwork Reduction Act of Committees/ucm408555.htm. each presentation may be limited. If the 1995 Contact Person: Jennifer Shepherd, number of registrants requesting to This guidance refers to previously Center for Drug Evaluation and speak is greater than can be reasonably approved collections of information that Research, Food and Drug accommodated during the scheduled open public hearing session, FDA may mstockstill on DSK4VPTVN1PROD with NOTICES are subject to review by the Office of Administration, 10903 New Hampshire Management and Budget (OMB) under Ave., Bldg. 31, Rm. 2417, Silver Spring, conduct a lottery to determine the the Paperwork Reduction Act of 1995 MD 20993–0002, 301–796–9001, FAX: speakers for the scheduled open public (44 U.S.C. 3501–3520). The collections 301–847–8533, PDAC@fda.hhs.gov, or hearing session. The contact person will of information in 21 CFR parts 312 and FDA Advisory Committee Information notify interested persons regarding their 314 have been approved under OMB Line, 1–800–741–8138 (301–443–0572 request to speak by December 18, 2015. control numbers 0910–0014 and 0910– in the Washington, DC area). A notice in Persons attending FDA’s advisory 0001, respectively. the Federal Register about last minute committee meetings are advised that the VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1


Document Created: 2015-12-14 13:32:41
Document Modified: 2015-12-14 13:32:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough 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 draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 8, 2016.
ContactRachel E. Hartford, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301- 796-0319; 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 Citation80 FR 76504 
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