[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57990-57991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6313]


Prescription Drug User Fee Act VI Commitment To Assess Current 
Practices of the Food and Drug Administration and Sponsors in 
Communicating During Investigational New Drug Development; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the statement of work to assess 
current practices of FDA and sponsors in communicating during 
investigational new drug (IND) development and identify best practices 
and areas of improvement. The independent assessment is part of FDA 
performance commitments under the recent reauthorization of the 
Prescription Drug User Fee Act (PDUFA). The independent assessment of 
current practices of FDA and sponsors in communicating during drug 
development is described in detail in the document entitled ``PDUFA 
Reauthorization Performance Goals and Procedures Fiscal Years 2018 
Through 2022'' available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf. As part of FDA 
performance commitments described in this document, the assessment will 
be conducted by an independent contractor. FDA is providing for public 
comment on the statement of work before revising and requesting 
contractor proposals.

DATES: Submit either electronic or written comments by January 22, 
2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 22, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.
    You may submit comments 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,

[[Page 57991]]

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-2017-N-6313 for ``Prescription Drug User Fee Act VI Commitment to 
Assess Current Practices of the Food and Drug Administration and 
Sponsors in Communicating During Investigational New Drug 
Development.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Yoni Tyberg, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1151, Silver Spring, MD 20993, 301-348-
1718, Fax: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The IND phase of drug development is the time during which human 
trials of investigational drugs are conducted. During the IND phase, 
sponsors and FDA engage in many types of communications. To ensure the 
effectiveness of human drug review programs, it is critical that these 
communications be conducted in a timely and efficient manner.
    The timely review of the safety and effectiveness of new drugs and 
biologics is central to FDA's mission to protect and promote the public 
health. Prior to enactment of PDUFA in 1992, FDA's drug review process 
was relatively slow and not very predictable compared to that of other 
countries. Due to concerns expressed by both industry and patients at 
the time, Congress enacted PDUFA, which provided the added funds 
through user fees that enabled FDA to hire additional reviewers and 
support staff and upgrade its information technology systems. In return 
for additional resources, FDA agreed to certain review performance 
goals, such as completing reviews of new drug applications and 
biologics license applications and taking regulatory actions on them in 
predictable timeframes. These changes revolutionized the drug approval 
process in the United States and enabled FDA to speed the application 
review process for new drugs and biologics without compromising the 
Agency's high standards for demonstration of safety, efficacy, and 
quality of new drugs and biologics prior to approval.
    PDUFA provides FDA with a source of stable, consistent funding that 
has made it possible for it to focus on promoting innovative therapies 
and help bring to market critical products for patients. When PDUFA was 
originally authorized in 1992, it had a 5-year term. The program has 
been subsequently reauthorized every 5 years with the most recent 
reauthorization occurring in 2017 for fiscal years (FYs) 2018-2022. To 
prepare for the 2017 reauthorization of PDUFA, FDA conducted 
negotiations with the regulated industry and held regular consultations 
with public stakeholders including patient advocates, consumer 
advocates, and health care professionals between September 2015 and 
February 2016. Following these discussions, related public meetings, 
and Agency requests for public comment, FDA published proposed 
recommendations for PDUFA VI for FYs 2018-2022. FDA committed under 
PDUFA VI to contract with an independent third party to assess current 
practices of FDA and sponsors in communicating during IND development 
and to identify best practices and areas of improvement.
    The statement of work can be accessed at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM577087.pdf.

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26437 Filed 12-7-17; 8:45 am]
 BILLING CODE 4164-01-P