Document ID: FDA-2013-N-0093-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; 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
Posted Date: 2016-07-21T04:00Z

[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47398-47399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17185]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2013-N-0093]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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 (the PRA).

DATES: Fax written comments on the collection of information by August 
22, 2016.

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 0910-0746. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: 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.

Evaluation of the Program for Enhanced Review Transparency and 
Communication for New Molecular Entity New Drug Applications (NME NDAs) 
and Original Biologics License Applications (BLAs) in Prescription Drug 
User Fee Acts (OMB Control Number 0910-0746)--Extension

    As part of its commitments in the Prescription Drug User Fee Act 
(PDUFA) V, FDA established a new review Program to promote greater 
transparency and increased communication between the FDA review team 
and the applicant on the most innovative products reviewed by the 
Agency. The Program applies to all NME NDAs and original BLAs that are 
received from October 1, 2012, through September 30, 2017. The Program 
is described in detail in section II.B of the document entitled ``PDUFA 
Reauthorization Performance Goals and Procedures Fiscal Years 2013 
through 2017'' (the Commitment Letter) (available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
    The goals of the Program are to increase the efficiency and 
effectiveness of the first review cycle and decrease the number of 
review cycles necessary for approval so that patients have timely 
access to safe, effective, and high-quality new drugs and biologics. A 
key aspect of the Program is an interim and final assessment that will 
evaluate how well the parameters of the Program have achieved the 
intended goals. The PDUFA V Commitment Letter specifies that the 
assessments be conducted by an independent contractor and that they 
include interviews of pharmaceutical manufacturers who submit NME NDAs 
and original BLAs to the Program in PDUFA V. The contractor for the 
assessments of the Program is Eastern Research Group, Inc. (ERG), and 
the statement of work for the assessments is available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM304793.pdf.
    In accordance with the PDUFA V Commitment Letter, FDA contracted 
with ERG to conduct independent interviews of applicants after FDA 
issues a first-cycle action for applications reviewed under the 
Program. The purpose of these interviews is to collect feedback from 
applicants on the success of the Program in increasing review 
transparency and communication during the review process. ERG will 
anonymize and aggregate sponsor responses prior to inclusion in the 
assessments and any

[[Page 47399]]

presentation materials at public meetings. FDA will publish ERG's 
assessments, with interview results and findings, in the Federal 
Register for public comment.
    Description of Respondents: The respondents to this collection of 
information are sponsor representatives for NME NDAs and original BLAs.
    In the Federal Register of December 10, 2015 (80 FR 76699), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
        Portion of study             Number of     responses per   Total  annual    burden  per     Total hours
                                    respondents     respondent       responses       response
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Pre-test........................               5               1               5             1.5            7.50
Interviews......................             135               1             135             1.5          202.50
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    Total.......................  ..............  ..............  ..............  ..............             210
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA typically reviews approximately 40 to 45 NME NDAs and original 
BLAs per year. ERG interviews 1 to 3 sponsor representatives at a time 
for each application that receives a first-cycle action from FDA, up to 
135 sponsor representatives per year. ERG conducts a pretest of the 
interview protocol with five respondents. FDA estimates that it will 
take 1.0 to 1.5 hours to complete the pretest, for a total of a maximum 
of 7.5 hours. We estimate that up to 135 respondents will take part in 
the post-action interviews each year, with each interview lasting 1.0 
to 1.5 hours, for a total of a maximum of 202.5 hours. Thus, the total 
estimated annual burden is 210 hours. FDA's burden estimate is based on 
prior experience with similar interviews with the regulated community.

    Dated: July 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17185 Filed 7-20-16; 8:45 am]
BILLING CODE 4164-01-P