[Federal Register Volume 84, Number 48 (Tuesday, March 12, 2019)]
[Notices]
[Pages 8877-8879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04429]


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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; 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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 351(k) biologics 
license applications (BLAs) to FDA under the Program for Enhanced 
Review Transparency and Communication (the Program) during FYs 2018 
through 2021.

DATES: Submit either electronic or written comments on the collection 
of information by May 13, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 13, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 13, 2019. Comments

[[Page 8878]]

received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 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.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
[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, 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 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/

[[Page 8879]]

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 ERG's assessments with interview 
results and findings.
    We estimate the burden of the information collection 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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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 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 1.0 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 1.0 to 1.5 hours, we 
calculate a total of 112.5 annual burden hours.

    Dated: March 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04429 Filed 3-11-19; 8:45 am]
 BILLING CODE 4164-01-P