
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76699-76701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31100]


-----------------------------------------------------------------------

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 Acts

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
involving interviews of pharmaceutical manufacturers who submit new 
molecular entity (NME) new drug 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 February 8, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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, 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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2013-N-0093] for ``Agency Information Collection Activities: 
Proposed Collection; Comment Request; Evaluation of the Program for 
Enhanced Review Transparency and

[[Page 76700]]

Communication for New Molecular Entity New Drug Applications and 
Original Biologics License Applications in Prescription Drug User Fee 
Acts.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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, including 
each proposed extension of an existing 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 Prescription Drug User Fee 
Acts

(OMB Control Number 0910-0746)--Extension

    As part of its commitments in 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 NMEs, 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 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.
    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 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 NMEs, 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.

[[Page 76701]]

    Thus, FDA estimates the burden of this collection of information as 
follows:

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


    Dated: December 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31100 Filed 12-9-15; 8:45 am]
 BILLING CODE 4164-01-P


