82 FR 61764 - Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 249 (December 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 249 (December 29, 2017)
| Page Range | 61764-61766 | |
| FR Document | 2017-28139 |
[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)] [Notices] [Pages 61764-61766] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-28139] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6564] Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration; 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 ``Best Practices for Communication Between IND Sponsors and FDA During Drug Development.'' Timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development facilitate earlier availability of safe and effective drugs to the American public. This guidance describes FDA's philosophy regarding timely interactive communication with IND sponsors as a core activity; describes the scope of appropriate interactions between FDA review teams and IND sponsors; outlines the types of advice appropriate for sponsors to seek from FDA in pursuing their drug development programs; describes the general expectations for the timing of FDA responses to IND sponsor inquiries; describes best practices and communication methods to facilitate interactions between FDA review teams and IND sponsors during drug development; and includes 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 guidance finalizes the draft guidance issued on December 9, 2015. DATES: The announcement of the guidance is published in the Federal Register on December 29, 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 [[Page 61765]] 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: 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-2017-D-6564 for ``Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration; 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 CFR 10.115(g)(5)). 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 B. Kichline, 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 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 (PDUFA V), described in PDUFA Reauthorization Performance Goals 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 of October 29, 2014 (79 FR 64397), or who provided input directly to CDER's Enhanced Communication Team. This guidance was published as a draft guidance on December 9, 2015. The following changes were made to the guidance: Biosimilar biological product development information was expanded and Biosimilar User Fee Act (BsUFA) meeting types were added. Roles and responsibilities for regulatory project managers were clarified. Language describing the formal communication plan for applications in PDUFA Program for Enhanced Review Transparency and Communication for NME NDAs \1\ and Original BLAs \2\ (also known as the Program) and for biologic biosimilar applications reviewed under BsUFA was added. --------------------------------------------------------------------------- \1\ New Molecular Entity New Drug Applications \2\ Biologics License Applications --------------------------------------------------------------------------- Meeting request parameters were revised in alignment with PDUFA VI. Additional information was added to the Resources for Sponsors and Additional Contacts sections. 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 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. 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 information collection described in 21 CFR part 312 from IND sponsors is approved by OMB [[Page 61766]] under control number 0910-0014. The information collection described in the guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' is approved by OMB under control number 0910-0429. The information collection described in the guidance for industry entitled ``Formal Dispute Resolution: Sponsor Appeals Above the Division Level'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM343101.pdf) is approved by OMB under control number 0910-0430. The information collection described in the ``Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts'' is approved by OMB under control number 0910-0746. The information collection described in the guidance for industry entitled ``Expedited Programs for Serious Conditions-- Drugs and Biologics'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf) is approved by OMB under control number 0910-0765. The information collection described in the guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM345649.pdf) is approved by OMB under control number 0910-0802. 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: December 19, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-28139 Filed 12-28-17; 8:45 am] BILLING CODE 4164-01-P
![61764 Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices
4th Floor, Silver Spring, MD 20993– PDUFA Products’’ published March 11, ACTION: Notice of availability.
0002, or Office of Communication, 2015, have been withdrawn.
Outreach, and Development, Center for This draft guidance is being issued SUMMARY: The Food and Drug
Biologics Evaluation and Research, consistent with FDA’s good guidance Administration (FDA or Agency) is
Food and Drug Administration, 10903 practices regulation (21 CFR 10.115). announcing the availability of a
New Hampshire Ave., Bldg. 71, Rm. The draft guidance, when finalized, will guidance for industry and review staff
3128, Silver Spring, MD 20993–0002. represent the current thinking of FDA entitled ‘‘Best Practices for
Send one self-addressed adhesive label on formal meetings between FDA and Communication Between IND Sponsors
to assist that office in processing your sponsors or applicants of PDUFA and FDA During Drug Development.’’
requests. See the SUPPLEMENTARY products. It does not establish any rights Timely, transparent, and effective
INFORMATION section for electronic for any person and is not binding on communications between
FDA or the public. You can use an investigational new drug application
access to the draft guidance document.
alternative approach if it satisfies the (IND) sponsors and FDA at critical
FOR FURTHER INFORMATION CONTACT: junctures in drug development facilitate
requirements of the applicable statutes
Rachel B. Kichline, Center for Drug and regulations. This guidance is not earlier availability of safe and effective
Evaluation and Research, Food and subject to Executive Order 12866. drugs to the American public. This
Drug Administration, 10903 New guidance describes FDA’s philosophy
Hampshire Ave., Bldg. 22, Rm. 6312, II. The Paperwork Reduction Act of regarding timely interactive
Silver Spring, MD 20993–0002, 301– 1995 communication with IND sponsors as a
796–0319; or Stephen Ripley, Center for This draft guidance refers to core activity; describes the scope of
Biologics Evaluation and Research, previously approved collections of appropriate interactions between FDA
Food and Drug Administration, 10903 information that are subject to review by review teams and IND sponsors;
New Hampshire Ave., Bldg. 71, Rm. the Office of Management and Budget outlines the types of advice appropriate
7301, Silver Spring, MD 20993–0002, (OMB) under the Paperwork Reduction for sponsors to seek from FDA in
240–402–7911. Act of 1995 (44 U.S.C. 3501–3520). The pursuing their drug development
SUPPLEMENTARY INFORMATION: collections of information referred to in programs; describes the general
the guidance entitled ‘‘Formal Meetings expectations for the timing of FDA
I. Background Between the FDA and Sponsors or responses to IND sponsor inquiries;
Applicants’’ have been approved under describes best practices and
FDA is announcing the availability of
OMB control number 0910–0429. The communication methods to facilitate
a draft guidance for industry entitled
collections of information for Form FDA interactions between FDA review teams
‘‘Formal Meetings Between the FDA and
1571 and end-of-phase 2 meetings have and IND sponsors during drug
Sponsors or Applicants of PDUFA
been approved under OMB control development; and includes expectations
Products.’’ This draft guidance provides
number 0910–0014 and collections of on appropriate methods and frequency
recommendations to industry on formal
information for Form FDA 356h have of such communications. This guidance
meetings between FDA and sponsors or
been approved under OMB control does not apply to communications or
applicants relating to the development
number 0910–0338. inquiries from industry trade
and review of products regulated by the organizations, consumer or patient
Center for Drug Evaluation and Research III. Electronic Access advocacy organizations, other
and the Center for Biologics Evaluation Persons with access to the internet government agencies, or other
and Research. This draft guidance does may obtain the draft guidance at https:// stakeholders not pursuing a
not apply to abbreviated new drug www.fda.gov/Drugs/Guidance development program under an IND.
applications, applications for biosimilar ComplianceRegulatoryInformation/ This guidance finalizes the draft
biological products, or submissions for Guidances/default.htm, https:// guidance issued on December 9, 2015.
medical devices. For the purposes of www.fda.gov/BiologicsBloodVaccines/ DATES: The announcement of the
this guidance, formal meeting includes GuidanceComplianceRegulatory guidance is published in the Federal
any meeting that is requested by a Information/default.htm, or https:// Register on December 29, 2017.
sponsor or applicant following the www.regulations.gov.
request procedures provided in this ADDRESSES: You may submit either
guidance and includes meetings Dated: December 19, 2017. electronic or written comments on
conducted in any format (i.e., face to Leslie Kux, Agency guidances at any time as
face, teleconference/videoconference, or Associate Commissioner for Policy. follows:
written response only). [FR Doc. 2017–28140 Filed 12–28–17; 8:45 am] Electronic Submissions
This guidance discusses the BILLING CODE 4164–01–P
Submit electronic comments in the
principles of good meeting management following way:
practices and describes standardized • Federal eRulemaking Portal:
procedures for requesting, preparing for, DEPARTMENT OF HEALTH AND
https://www.regulations.gov. Follow the
scheduling, conducting, and HUMAN SERVICES
instructions for submitting comments.
documenting such formal meetings. The Food and Drug Administration Comments submitted electronically,
general principles in this guidance may including attachments, to https://
be extended to other nonapplication- [Docket No. FDA–2017–D–6564] www.regulations.gov will be posted to
related meetings with external the docket unchanged. Because your
ethrower on DSK3G9T082PROD with NOTICES
constituents, insofar as this is possible. Best Practices for Communication
comment will be made public, you are
Between Investigational New Drug
The previous guidance for industry solely responsible for ensuring that your
Application Sponsors and the Food
‘‘Formal Meetings Between the FDA and comment does not include any
and Drug Administration; Guidance for
Sponsors or Applicants’’ published May confidential information that you or a
Industry and Review Staff; Availability
19, 2009, and the draft guidance for third party may not wish to be posted,
industry ‘‘Formal Meetings Between the AGENCY: Food and Drug Administration, such as medical information, your or
FDA and Sponsors or Applicants of HHS. anyone else’s Social Security number, or
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![61766 Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices
under control number 0910–0014. The DEPARTMENT OF HEALTH AND Public attendance at this meeting is
information collection described in the HUMAN SERVICES limited to space available. Individuals
guidance for industry entitled ‘‘Formal who plan to attend and need special
Meetings Between the FDA and Meeting of the Advisory Committee on assistance, such as sign language
Sponsors or Applicants of PDUFA Minority Health interpretation or other reasonable
Products’’ is approved by OMB under AGENCY: Office of Minority Health, accommodations, should notify the
control number 0910–0429. The Office of the Secretary, Department of designated contact person at least
information collection described in the Health and Human Services. fourteen (14) business days prior to the
guidance for industry entitled ‘‘Formal meeting. Members of the public will
ACTION: Notice of meeting.
Dispute Resolution: Sponsor Appeals have an opportunity to provide
Above the Division Level’’ (available at SUMMARY: As stipulated by the Federal comments at the meeting. Public
https://www.fda.gov/downloads/Drugs/ Advisory Committee Act, the comments will be limited to three
Department of Health and Human minutes per speaker. Individuals who
GuidanceComplianceRegulatory
Services (HHS) is hereby giving notice would like to submit written statements
Information/Guidances/
that the Advisory Committee on should mail or fax their comments to
UCM343101.pdf) is approved by OMB the Office of Minority Health at least
Minority Health (ACMH) will hold a
under control number 0910–0430. The meeting. This meeting will be open to seven (7) business days prior to the
information collection described in the the public. Preregistration is required meeting. Any members of the public
‘‘Evaluation of the Program for for both public attendance and who wish to have printed material
Enhanced Review Transparency and comment. Any individual who wishes distributed to ACMH committee
Communication for New Molecular to attend the meetings and/or members should submit their materials
Entity New Drug Applications and participate in the public comment to the Designated Federal Officer,
Original Biologics License Applications session should email OMH-ACMH@ ACMH, Tower Building, 1101 Wootton
in Prescription Drug User Fee Acts’’ is hhs.gov. Information about the meeting Parkway, Suite 600, Rockville,
approved by OMB under control is available from the designated contact Maryland 20852, prior to close of
number 0910–0746. The information and will be posted on the website for business on Monday, March 19, 2018.
collection described in the guidance for the Office of Minority Health (OMH), Dated: December 22, 2017.
industry entitled ‘‘Expedited Programs www.minorityhealth.hhs.gov.
Minh Wendt,
for Serious Conditions—Drugs and Information about ACMH activities can
be found on the OMH website under the Designated Federal Officer, Advisory
Biologics’’ (available at https:// Committee on Minority Health.
www.fda.gov/downloads/Drugs/ heading About OMH.
[FR Doc. 2017–28161 Filed 12–28–17; 8:45 am]
GuidanceComplianceRegulatory DATES: The meeting will be held on
BILLING CODE 4150–29–P
Information/Guidances/ Monday, March 26, 2018, from 9:00 a.m.
UCM358301.pdf) is approved by OMB to 5:00 p.m. and Tuesday, March 27,
under control number 0910–0765. The 2018, from 9:00 a.m. to 1:00 p.m.
DEPARTMENT OF HEALTH AND
information collection described in the ADDRESSES: The meeting will be held at
HUMAN SERVICES
guidance for industry entitled ‘‘Formal the 5600 Fishers Lane Building, Room
Meetings Between the FDA and 05E29, 5600 Fishers Lane, Rockville, National Institutes of Health
Biosimilar Biological Product Sponsors Maryland 20857.
or Applicants’’ (available at https:// FOR FURTHER INFORMATION CONTACT: Dr. National Institute of Allergy and
www.fda.gov/downloads/Drugs/ Minh Wendt, Designated Federal Infectious Diseases; Notice of Closed
GuidanceComplianceRegulatory Officer, Advisory Committee on Meetings
Minority Health, Office of Minority
Information/Guidances/
Health, Department of Health and Pursuant to section 10(d) of the
UCM345649.pdf) is approved by OMB Federal Advisory Committee Act, as
Human Services, Tower Building, 1101
under control number 0910–0802. Wootton Parkway, Suite 600, Rockville, amended, notice is hereby given of the
III. Electronic Access Maryland 20852. Phone: 240–453–8222; following meetings.
fax: 240–453–8223; email OMH-ACMH@ The meetings will be closed to the
Persons with access to the internet hhs.gov. public in accordance with the
may obtain the guidance at https:// SUPPLEMENTARY INFORMATION: In provisions set forth in sections
www.fda.gov/Drugs/Guidance accordance with Public Law 105–392, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
ComplianceRegulatoryInformation/ the ACMH was established to provide as amended. The grant applications and
Guidances/default.htm, https:// advice to the Deputy Assistant Secretary the discussions could disclose
www.fda.gov/BiologicsBloodVaccines/ for Minority Health on improving the confidential trade secrets or commercial
GuidanceComplianceRegulatory health of each racial and ethnic property such as patentable material,
Information/default.htm, or https:// minority group and on the development and personal information concerning
www.regulations.gov. of goals and specific program activities individuals associated with the grant
Dated: December 19, 2017.
of the OMH. applications, the disclosure of which
The topics to be discussed during this would constitute a clearly unwarranted
Leslie Kux, meeting will include strategies to invasion of personal privacy.
Associate Commissioner for Policy. improve the health of racial and ethnic
ethrower on DSK3G9T082PROD with NOTICES
Name of Committee: National Institute of
[FR Doc. 2017–28139 Filed 12–28–17; 8:45 am] minority populations through the
Allergy and Infectious Diseases Special
BILLING CODE 4164–01–P development of health policies and Emphasis Panel; AIDS Research Review
programs that will help eliminate health Committee (AIDSRRC) Independent SEP.
disparities with an emphasis on serious Date: January 18, 2018.
mental illness. The recommendations Time: 1:00 p.m. to 2:00 p.m.
will be given to the Deputy Assistant Agenda: To review and evaluate grant
Secretary for Minority Health. applications.
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Document Created: 2018-01-03 13:16:45
Document Modified: 2018-01-03 13:16:45
| 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 December 29, 2017. | |
| Contact | Rachel B. Kichline, 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 Citation | 82 FR 61764 |
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