[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11652-11654]
From the Federal Register Online via the Government Publishing 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. [email protected].
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