Document ID: FDA-2013-N-0093-0012
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Review  Transparency and Communication in Reviews of 351(k) Biologics License
Applications in Biosimilars User Fee Act
Posted Date: 2019-08-19T04:00Z

[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42926-42927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17713]

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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; Review Transparency 
and Communication in Reviews of 351(k) Biologics License Applications 
in Biosimilars 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 
September 18, 2019.

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 oira_submission@omb.eop.gov. 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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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 and 
Original Biologics License Applications in Prescription Drug User Fee 
Acts and 351(k) Biologics License Applications in Biosimilars User Fee 
Act

OMB Control Number 0910-0746--Extension

    This information collection supports the above captioned review 
program (``the Program''). The Program is part of our performance 
commitment under the fifth and sixth authorizations of the Prescription 
Drug User Fee Act (PDUFA), which allows us to collect user fees for the 
review of human drug and biologics applications for FYs 2013 through 
2021, and the second authorization of the Biosimilars User Fee Act 
(BsUFA II), which applies to 351(k) BLAs for FYs 2018 through 2021. The 
Program is described in detail in FDA's Commitment Letters for PDUFA VI 
and BsUFA II, available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf and https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf.
    The Program goals 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 extension of the Program to BsUFA II is to conduct an interim and 
final assessment that will evaluate how well the parameters of the 
Program have achieved the intended goals. The BsUFA II Commitment 
Letter specifies that an independent contractor can conduct the 
assessments and specifies that they include interviews of sponsors who 
submit 351(k) BLAs to the Program in BsUFA II. In accordance with the 
PDUFA V and BsUFA II Commitment Letters, we contracted Eastern Research 
Group, Inc. (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 transparency and 
communication of reviews during the review process. ERG will anonymize 
and aggregate sponsor responses before inclusion in the assessments and 
presentation materials at public meetings. We will publish in the 
Federal Register for public comment

[[Page 42927]]

ERG's assessments with interview results and findings.
    In the Federal Register of March 12, 2019 (84 FR 8877), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection 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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Pre-test........................               5               1               5             1.5             7.5
Interviews......................              75               1              75             1.5           112.5
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    Total.......................  ..............  ..............  ..............  ..............             120
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since the last OMB approval of the information collection, we have 
adjusted our estimate downward by 60 survey respondents. We base our 
estimate on the most recent number of annual surveys. ERG interviews 
between one and three sponsor representatives for each 351(k) BLA 
first-cycle action issued for applications reviewed under the Program. 
ERG also conducts a pretest of the interview protocol with five 
respondents. Assuming it will take 1 to 1.5 hours to complete the 
pretest, we calculate a total of 7.5 annual burden hours. We estimate 
that up to 75 respondents will take part in the post-action interviews 
each year. Assuming each interview will last 1 to 1.5 hours, we 
calculate a total of 112.5 annual burden hours.

    Dated: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17713 Filed 8-16-19; 8:45 am]
 BILLING CODE 4164-01-P