[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16006-16008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05814]


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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; New Molecular Entity New Drug Applications and 
Original Biologics License Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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

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response to the notice. This notice solicits comments on information 
collection associated with evaluating FDA's program for Enhanced Review 
Transparency and Communication (the Program) of new molecular entity 
new drug applications and original biologics license applications 
(BLAs).

DATES: Submit either electronic or written comments on the collection 
of information by May 20, 2022.

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 20, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 20, 2022. Comments 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 ``New Molecular Entity New Drug Applications and 
Original Biologics License Applications.'' 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, 240-
402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

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. 3501-3521), 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 351(a) Biologics License Applications in Prescription Drug 
User Fee Acts and 351(k) Biologics License Applications in Biosimilar 
User Fee Acts

OMB Control Number 0910-0746--Extension

    This information collection supports the evaluation of certain 
performance goals and procedures set forth in what is known as FDA's 
``goals letter'' or ``commitment letter'' under the sixth authorization 
of the Prescription Drug User Fee Act (PDUFA VI) and the

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second authorization of the Biosimilar User Fee Act (BsUFA II). The 
goals letters are the result of Agency, industry, and public input, as 
Congressionally mandated under the applicable statutes. The documents 
entitled ``PDUFA Reauthorization Performance Goals and Procedures 
Fiscal Years 2018 Through 2022,'' and ``Biosimilar Biological Product 
Reauthorization Performance Goals and Procedures Fiscal Years 2018 
Through 2022'' represent current performance goals agreed to by FDA in 
support of these respective programs. These documents are available at: 
https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf; and https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf. 
Work to reauthorize these authorities from Fiscal Years 2023 to 2027 is 
ongoing.
    To implement certain performance goals, we established the Program 
to promote greater transparency and increased communication between the 
FDA review team and the applicant on the most innovative products that 
we review. The Program goals are intended 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. Based on sponsors' 
responses and other data, on December 2, 2020, we published an interim 
report that is available on FDA's website at https://www.fda.gov/media/144130/download. We learned that under BsUFA II review, teams have been 
effective in enhancing review transparency and communication, with 
milestone meetings also enhancing the predictability of the review 
process. We have also adapted certain good practices identified through 
the Program, including providing pre-submission advice and templates; 
allocating time for applicant-identified discussion topics in late-
cycle meetings where feasible; and recommending request response times 
of greater than 2 days for applicants with a global presence. We expect 
to continue these assessments.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 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             7.5
Interviews......................              75               1              75             1.5           112.5
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    Total.......................  ..............  ..............              80  ..............             120
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We plan interviews with up to three applicant representatives per 
each 351(k) BLA first-cycle action issued for applications reviewed 
under the Program. In addition, a pretest of the interview protocol 
with five respondents will also be conducted. Based on our prior 
experience with the Program and communications with the regulated 
industry, we assume that five applicant representatives will expend 
approximately 1.5 hours to complete the pretest, for a total of 7.5 
burden hours. We further assume that up to 75 applicant representatives 
(up to 3 representatives for each of up to 25 applications) will 
participate in the post-action interviews each year and that each 
interview will last approximately 1.5 hours, for a total of 120 burden 
hours. Cumulatively, we estimate an overall decrease to the information 
collection, which corresponds to a decrease in submissions received by 
the Agency over the last 3 years.

    Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05814 Filed 3-18-22; 8:45 am]
BILLING CODE 4164-01-P


