[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26782-26783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-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 Act

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.

DATES: Fax written comments on the collection of information by June 7, 
2013.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title 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 
Act. Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, [email protected].

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.

[[Page 26783]]

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 
Act--(OMB Control Number 0910-New)

    As part of its commitments in PDUFA V. FDA has 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 
New Molecular Entities (NMEs), New Drug Applications (NDAs), and 
original Biologics License Applications (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 NMEs, 
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.
    Therefore, in accordance with the PDUFA V Commitment Letter, FDA 
proposes to have ERG 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 presentation materials at public meetings. FDA will 
publish ERG's assessments (with interview results and findings) in the 
Federal Register for public comment.
    In the Federal Register of February 19, 2013 (78 FR 11652), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA typically reviews approximately 40 to 45 NMEs, NDAs, and 
original BLAs per year. ERG will interview one to three sponsor 
representatives at a time for each application that receives a first-
cycle action from FDA up to 135 sponsor representatives per year. Thus, 
FDA estimates 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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Pretest........................               5               1               5             1.5              7.5
Interviews.....................             135               1             135             1.5            202.5
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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.

    ERG will conduct 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: May 3, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-10898 Filed 5-7-13; 8:45 am]
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