Document ID: FDA-2013-N-0093-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act
Posted Date: 2013-02-19T05:00Z

[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11652-11654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03705]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0093]

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a proposed information collection involving 
interviews of pharmaceutical manufacturers who submit new molecular 
entity (NME) new drug

[[Page 11653]]

applications (NDAs) and original biologics license applications (BLAs) 
to FDA under the Program for Enhanced Review Transparency and 
Communication (``the Program'') during fiscal years (FYs) 2013-2017. 
The Program is part of the FDA performance commitments under the fifth 
authorization of the Prescription Drug User Fee Act (PDUFA), which 
allows FDA to collect user fees for the review of human drug and 
biologics applications for FYs 2013-2017.

DATES: Submit either electronic or written comments on the collection 
of information by April 22, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. All comments should be identified with the 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. Ila.Mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Evaluation of the Program for Enhanced Review Transparency and 
Communication for New Molecular Entity New Drug Applications and 
Original Biologics License Applications in PDUFA V: Interviews of 
Applicants in the Program (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 
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.
    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.
    FDA typically reviews approximately 40 to 45 NME NDAs and original 
BLAs per year. ERG will interview 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. 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
        Portion of study             Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
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Pretest.........................               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.

    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

[[Page 11654]]

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: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03705 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P