81 FR 47398 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 140 (July 21, 2016)

Page Range		47398-47399
FR Document		2016-17185

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).

Federal Register, Volume 81 Issue 140 (Thursday, July 21, 2016)

[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47398-47399]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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 [email protected]. 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, 
[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.

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\
----------------------------------------------------------------------------------------------------------------
                                                     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.

    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

47398 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices

FOR FURTHER INFORMATION CONTACT: Julia Dated: July 14, 2016. Evaluation of the Program for
Oriani, Center for Veterinary Medicine Leslie Kux, Enhanced Review Transparency and
(HFV–151), Food and Drug Associate Commissioner for Policy. Communication for New Molecular
Administration, 7500 Standish Pl., [FR Doc. 2016–17188 Filed 7–20–16; 8:45 am]
Entity New Drug Applications (NME
Rockville, MD 20855, 240–402–0788, NDAs) and Original Biologics License
BILLING CODE 4164–01–P
julia.oriani@fda.hhs.gov. Applications (BLAs) in Prescription
SUPPLEMENTARY INFORMATION: Drug User Fee Acts (OMB Control
DEPARTMENT OF HEALTH AND Number 0910–0746)—Extension
I. Background
HUMAN SERVICES As part of its commitments in the
FDA is announcing the availability of
Prescription Drug User Fee Act
a draft revised guidance for industry #3
Food and Drug Administration (PDUFA) V, FDA established a new
entitled ‘‘General Principles for
review Program to promote greater
Evaluating the Human Food Safety of
[Docket No. 2013–N–0093] transparency and increased
New Animal Drugs used in Food-
communication between the FDA
Producing Animals.’’ This draft revised
Agency Information Collection review team and the applicant on the
guidance is intended to inform sponsors
Activities; Submission for Office of most innovative products reviewed by
of the scientific data and/or information
Management and Budget Review; the Agency. The Program applies to all
that may provide an acceptable basis to
Comment Request; Evaluation of the NME NDAs and original BLAs that are
determine that the residue of a new
Program for Enhanced Review received from October 1, 2012, through
animal drug in or on food, when
Transparency and Communication for September 30, 2017. The Program is
consumed, presents a reasonable
New Molecular Entity New Drug described in detail in section II.B of the
certainty of no harm to humans. This
Applications and Original Biologics document entitled ‘‘PDUFA
guidance describes a recommended
Reauthorization Performance Goals and
approach for providing human food License Applications in Prescription
Procedures Fiscal Years 2013 through
safety scientific data and/or Drug User Fee Acts
2017’’ (the Commitment Letter)
information. CVM acknowledges that
AGENCY: Food and Drug Administration, (available at http://www.fda.gov/
alternate approaches also may be
downloads/ForIndustry/UserFees/
appropriate and encourages sponsors to HHS.
PrescriptionDrugUserFee/
discuss with CVM whether an alternate
ACTION: Notice. UCM270412.pdf.
approach may be appropriate for
The goals of the Program are to
specific new animal drugs.
SUMMARY: The Food and Drug increase the efficiency and effectiveness
II. Significance of Guidance Administration (FDA) is announcing of the first review cycle and decrease
This level 1 draft revised guidance is that a proposed collection of the number of review cycles necessary
being issued consistent with FDA’s good information has been submitted to the for approval so that patients have timely
guidance practices regulation (21 CFR Office of Management and Budget access to safe, effective, and high-
10.115). The draft revised guidance, (OMB) for review and clearance under quality new drugs and biologics. A key
when finalized, will represent the the Paperwork Reduction Act of 1995 aspect of the Program is an interim and
current thinking of FDA on the type of final assessment that will evaluate how
(the PRA).
information sponsors provide to address well the parameters of the Program have
the human food safety of new animal DATES: Fax written comments on the achieved the intended goals. The
drugs used in food-producing animals. collection of information by August 22, PDUFA V Commitment Letter specifies
It does not establish any rights for any 2016. that the assessments be conducted by an
person and is not binding on FDA or the independent contractor and that they
ADDRESSES: To ensure that comments on include interviews of pharmaceutical
public. You can use an alternative the information collection are received,
approach if it satisfies the requirements manufacturers who submit NME NDAs
OMB recommends that written and original BLAs to the Program in
of the applicable statutes and comments be faxed to the Office of
regulations. PDUFA V. The contractor for the
Information and Regulatory Affairs, assessments of the Program is Eastern
III. Paperwork Reduction Act of 1995 OMB, Attn: FDA Desk Officer, FAX: Research Group, Inc. (ERG), and the
This draft guidance refers to 202–395–7285, or emailed to oira_ statement of work for the assessments is
previously approved collections of submission@omb.eop.gov. All available at http://www.fda.gov/
information found in FDA regulations. comments should be identified with the downloads/ForIndustry/UserFees/
These collections of information are OMB control number 0910–0746. Also PrescriptionDrugUserFee/
subject to review by the Office of include the FDA docket number found UCM304793.pdf.
Management and Budget (OMB) under in brackets in the heading of this In accordance with the PDUFA V
the Paperwork Reduction Act of 1995 document. Commitment Letter, FDA contracted
(44 U.S.C. 3501–3520). The collections with ERG to conduct independent
of information in 21 CFR part 514 have FOR FURTHER INFORMATION CONTACT: interviews of applicants after FDA
been approved under OMB control Food and Drug Administration, 8455 issues a first-cycle action for
Colesville Rd., COLE–14526, Silver applications reviewed under the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

number 0910–0032.
Spring, MD 20993–0002, PRAStaff@ Program. The purpose of these
IV. Electronic Access fda.hhs.gov. interviews is to collect feedback from
Persons with access to the Internet applicants on the success of the Program
may obtain the draft guidance at either SUPPLEMENTARY INFORMATION: In in increasing review transparency and
http://www.fda.gov/AnimalVeterinary/ compliance with 44 U.S.C. 3507, FDA communication during the review
GuidanceComplianceEnforcement/ has submitted the following proposed process. ERG will anonymize and
GuidanceforIndustry/default.htm or collection of information to OMB for aggregate sponsor responses prior to
http://www.regulations.gov. review and clearance. inclusion in the assessments and any

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Document Created: 2018-02-08 07:58:53
Document Modified: 2018-02-08 07:58:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by August 22, 2016.
Contact		Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 47398

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 140 (July 21, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration