Notice2022-05814
Agency Information Collection Activities; Proposed Collection; Comment Request; New Molecular Entity New Drug Applications and Original Biologics License Applications
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 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).
Full Text
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<title>Federal Register, Volume 87 Issue 54 (Monday, March 21, 2022)</title>
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[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16006-16008]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
[[Page 16007]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#df8f8d9e8cabbeb9b99fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="c292908391b6a3a4a482a4a6a3ecaaaab1eca5adb4">[email protected]</span></a>.
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
[[Page 16008]]
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:
<a href="https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf">https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf</a>; and <a href="https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf">https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf</a>.
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 <a href="https://www.fda.gov/media/144130/download">https://www.fda.gov/media/144130/download</a>. 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
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