[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48435-48437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3103]


Good Review Management Principles and Practices for New Drug 
Applications and Biologics License Applications; Draft Guidance for 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the availability of a draft guidance for industry and review staff 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 ``Good Review Management Principles and Practices for New Drug 
Applications and Biologics License Applications.'' This draft guidance 
describes the fundamental values and

[[Page 48436]]

operational principles that serve as the foundation for the review 
process. It also clarifies the roles and responsibilities of review 
staff and identifies ways in which applicants may support a robust and 
efficient review process. This draft guidance revises the guidance for 
review staff and industry entitled ``Good Review Management Principles 
and Practices for PDUFA Products'' issued April 2005.

DATES: Submit either electronic or written comments on the draft 
guidance by December 24, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     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-2018-D-3103 for ``Good Review Management Principles and Practices 
for New Drug Applications and Biologics License Applications.'' 
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.gpo.gov/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: Pinakini Patel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6367, Silver Spring, MD 20993-0002, 301-
796-7475; 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 ``Good Review Management Principles and 
Practices for New Drug Applications and Biologics License 
Applications.'' This draft guidance describes good review management 
principles and practices (GRMPs) for the review of a new drug 
application (NDA), biologics license application (BLA), or an efficacy 
supplement/supplement with clinical data. This guidance applies to 
human drug applications (as defined in section 735(1) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379g(1))) and 
biosimilar biological product applications (section 744G(4) of the FD&C 
Act (21 U.S.C. 379j-51(4))). This guidance also discusses the roles and 
responsibilities of review staff in managing the review process and 
identifies ways in which applicants may support an efficient and robust 
review process.
    This draft guidance revises the guidance for review staff and 
industry entitled ``Good Review Management Principles and Practices for 
PDUFA Products'' issued in April 2005. FDA committed to updating the 
2005 guidance as part of the Prescription Drug User Fee Act (PDUFA) VI 
and Biosimilar User Fee Act (BsUFA) II. This draft guidance meets that 
commitment by reflecting advances in the PDUFA program and 
implementation of BsUFA. This draft guidance also reflects the 
evolution of GRMPs to support new regulatory programs such as 
breakthrough therapy, the Program for Enhanced Review

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Transparency and Communication for NME (New Molecular Entity) NDAs and 
Original BLAs, and risk evaluation and mitigation strategies.
    In addition, the draft guidance has been consolidated to focus on 
the fundamental values and operational principles that serve as the 
foundation for the GRMPs. Details of the review process are covered in 
other documents referenced by this guidance. Fundamental values and 
operational principles should remain relatively constant over time, 
while processes must be able to adapt and respond to scientific 
advances in product development and evolving public health needs.
    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 GRMPs for NDAs 
and BLAs. 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. Electronic Access

    Persons with access to the internet may obtain the draft 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: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20789 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P