Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Program, 90705-90708 [2024-26801]
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Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–26780 Filed 11–15–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10398 #85]
Medicaid and Children’s Health
Insurance Program (CHIP) Generic
Information Collection Activities:
Proposed Collection; Comment
Request
Centers for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:
On May 28, 2010, the Office
of Management and Budget (OMB)
issued Paperwork Reduction Act (PRA)
guidance related to the ‘‘generic’’
clearance process. Generally, this is an
expedited process by which agencies
may obtain OMB’s approval of
collection of information requests that
are ‘‘usually voluntary, low-burden, and
uncontroversial collections,’’ do not
raise any substantive or policy issues,
and do not require policy or
methodological review. The process
requires the submission of an
overarching plan that defines the scope
of the individual collections that would
fall under its umbrella. This Federal
Register notice seeks public comment
on one or more of our collection of
information requests that we believe are
generic and fall within the scope of the
umbrella. Interested persons are invited
to submit comments regarding our
burden estimates or any other aspect of
this collection of information,
including: the necessity and utility of
the proposed information collection for
the proper performance of the agency’s
functions, the accuracy of the estimated
burden, ways to enhance the quality,
utility and clarity of the information to
be collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
December 2, 2024.
ADDRESSES: When commenting, please
reference the applicable form number
(CMS–10398 #85) and the OMB control
number (0938–1148). To be assured
consideration, comments and
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SUMMARY:
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recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: CMS–10398 #85/OMB
control number: 0938–1148, Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
medicare/regulations-guidance/
legislation/paperwork-reduction-act1995/pra-listing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at 410–786–4669.
SUPPLEMENTARY INFORMATION: Following
is a summary of the use and burden
associated with the subject information
collection(s). More detailed information
can be found in the collection’s
supporting statement and associated
materials (see ADDRESSES).
Generic Information Collection
1. Title of Information Collection: 3.1–
M State Plan Amendment (SPA)
Templates for Eligible Juveniles Who
are Inmates of a Public Institution; Type
of Information Collection Request: New
information collection request
information request; Use: Section 5121
of the Consolidated Appropriation Act
of 2023 (CAA, 2023) creates a new
mandate for states by amending section
1902(a)(84) of the Social Security Act
(the Act) (42 U.S.C. 1396a) to require
states to provide specific screening and
diagnostic services and targeted case
management (including referrals) in the
30 days prior to release from
incarceration, and targeted case
management (TCM) (including referrals)
for at least 30 days post release for
eligible juveniles who are inmates of a
public institution, post adjudication.
The requirements are effective January
1, 2025.
To comply with the amendments
states must submit a Medicaid SPA
attesting that the state has developed an
internal operation plan, and in
accordance with such plan, will provide
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coverage during the statutory pre- and
post-release period of screening,
diagnostic, and TCM services for
eligible juveniles who are within 30
days of release post adjudication.
States have the option to lift the
Medicaid inmate payment and CHIP
eligibility exclusions and provide
coverage of pre-release Medicaid and
CHIP services (for electing states) and
makes available federal matching funds
for the full breadth of Medicaid and
CHIP benefits to eligible juveniles who
are incarcerated and pending
disposition of charges. States selecting
this state plan option must provide to
eligible juveniles all mandatory and
optional services to which they are
otherwise entitled under the state plan.
During the period when an eligible
juvenile is incarcerated and pending
disposition of charges, this is essentially
a full lifting of the Medicaid inmate
payment exclusion and CHIP eligibility
exclusion. States cannot choose to
provide a limited array of state plan
services under this option. An
operational plan is not required for this
state option.
For states that wish to elect the option
in section 5122 of the CAA, 2023, states
should submit a SPA attesting to CMS
that they are also electing coverage for
any Medicaid or CHIP state plan
services for eligible juveniles pending
disposition of charges to which the
beneficiary would otherwise be entitled,
if not for their incarceration status.
Form Number: CMS–10398 #85 (OMB
control number: 0938–1148); Frequency:
Once and on occasion; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 56; Total
Annual Responses: 168; Total Annual
Hours: 4,872. (For policy questions
regarding this collection contact:
Marlana Thieler at 410–786–6274.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–26713 Filed 11–15–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4467]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
User Fee Program
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices
Written/Paper Submissions
Notice.
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 information
collection associated with FDA’s
Prescription Drug User Fee program.
SUMMARY:
Either electronic or written
comments on the collection of
information must be submitted by
January 17, 2025.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
January 17, 2025. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
ADDRESSES:
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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’’).
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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–
2024–N–4467 for ‘‘Prescription Drug
User Fee Program.’’ 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-201509-18/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
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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:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
Prescription Drug User Fee Program
OMB Control Number 0910–0297—
Revision
This information collection supports
implementation of the FDA Prescription
Drug User Fee program (called
‘‘PDUFA’’ in reference to the
Prescription Drug User Fee Act). Under
the prescription drug user fee provisions
of the Federal Food, Drug, and Cosmetic
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Act (FD&C Act) (sections 735 and 736
(21 U.S.C. 379g and 379h)), we have the
authority to assess and collect annual
program fees for prescription drug
products approved under certain new
drug applications (NDAs) and biologics
license applications (BLAs). Also under
this authority, pharmaceutical
companies pay an application fee for
certain NDAs and BLAs submitted to
FDA for review. Because the submission
of user fees concurrently with
applications is required, review of an
application by FDA cannot begin until
the fee is submitted.
PDUFA must be reauthorized every 5
years. On September 30, 2022, the
President signed into law the FDA User
Fee Reauthorization Act of 2022, which
includes the reauthorization of PDUFA
through September 30, 2027 (https://
www.fda.gov/industry/prescriptiondrug-user-fee-amendments/pdufa-viifiscal-years-2023-2027). PDUFA VII
provides for the continued timely
review of NDAs and BLAs. Since the
initial passage of PDUFA, user fees have
played an important role in expediting
the drug review and approval process.
PDUFA VII reauthorization also
includes commitments to meet certain
performance goals and procedures. The
commitment goals represent the product
of FDA’s discussions with the regulated
industry and public stakeholders, as
mandated by Congress.
We are revising the collection to
include our current commitment goals,
as set forth in the document ‘‘PDUFA
Reauthorization Performance Goals and
Procedures Fiscal Years 2023 Through
2027,’’ found on our website at https://
www.fda.gov/media/151712/
download?attachment. The
commitment goals represent the product
of FDA’s discussions with the regulated
industry and public stakeholders, as
mandated by Congress. FDA is
committed to meeting these goals and to
continuous operational improvements
associated with PDUFA
implementation. The commitment goals
provide for the development and
issuance of topic-specific guidance. We
maintain a searchable guidance database
on our website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents. In publishing the
respective notices of availability for
each guidance document, we include an
analysis under the PRA and invite
public comment on the associated
information collection
recommendations. In addition, all
Agency guidance documents are issued
in accordance with our Good Guidance
Practices regulations in 21 CFR 10.115,
which provide for public comment at
any time.
To assist respondents with the
information collection, we developed
Form FDA 3397 entitled ‘‘Prescription
Drug User Fee Cover Sheet.’’ Additional
information and associated instructions
may be found on our website at https://
www.fda.gov/industry/fda-user-feeprograms. The cover sheet (Form FDA
3397) is submitted for original NDAs,
BLAs and resubmissions of these
original applications after withdrawal
before filing or refusal to file actions.
The form is not submitted for certain
FDA-regulated products. The list of
exempted products is included under
the instructions to Form FDA 3397.
Relatedly, sections 735 and 736 of the
FD&C Act also provide for waiver,
reduction, exemption and refund
requests. We developed the guidance
document entitled ‘‘Guidance for
90707
Industry—Prescription Drug User Fee
Act Waivers, Reductions, and Refunds
for Drug and Biological Products,’’ and
Form FDA 3971 (Small Business Waiver
and Refund Request), which can be
found on our website at https://
www.fda.gov/media/131797/download,
as mandated by Congress.
We also developed Form FDA 4068,
‘‘Prescription Drug User Fee Act;
Waivers, Refunds, and Exemptions,’’
along with accompanying instructions,
to enable sponsors of designated orphan
products to request an exemption from
applicable fees under PDUFA and
included the form in the information
collection when the prior renewal was
submitted for approval. Use of the form
will provide the information required
for analysis and application of the
orphan exemption from user fees,
organizing the requested information for
easier data collection and streamlining
the review request. We find, however,
with this renewal, that use of the form
has not been implemented yet, pending
development of the OneNexus system
for management of the user fee systems.
Use of the form is anticipated once the
OneNexus system is developed and
implemented for the PDUFA program.
The PDUFA information collection
and all user fee cover sheets, including
the ‘‘Prescription Drug User Fee Cover
Sheet’’ (Form FDA 3397), are accessed
and submitted electronically, as
required by statute, through FDA’s
electronic systems such as the
Document Archiving Reporting and
Regulatory Tracking System (DARRTS),
Electronic Submission Gateway (ESG),
and Panorama.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Prescription drug user fee activity
Number of
respondents
Number of
responses per
respondent
99
1.828
181
17 .........................
3,077
35
1
35
2 ...........................
70
13
4
132
1.69
1.5
1.24
22
6
164
24 .........................
12 .........................
0.5 (30 minutes) ...
528
72
82
....................
........................
408
..............................
3,829
Sections 735 and 736 of the FD&C Act (PDUFA waivers and
exemptions, not including small business waiver requests).
Section 736(d)(1)(C) of the FD&C Act and Form FDA 3971
(small business waivers).
Reconsideration Requests ..........................................................
Appeal Requests .........................................................................
User Fee Cover Sheet Form FDA 3397 submission with original NDAs and BLAs.
Total .....................................................................................
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1 There
Total annual
responses
Average
burden per
response
Total
hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of Agency records,
we estimate that the number of initial
waiver requests submitted annually
(excluding small business waiver
requests under section 736(d)(1)(C)) of
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the FD&C Act) is 181, submitted by 99
different applicants.
We estimate that 35 respondents will
each submit a small business waiver
request annually. We have included in
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the burden estimate the time for
preparation and submission of
application fee waivers for small
businesses, including completion of
Form FDA 3971. Small businesses
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Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices
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requesting a waiver must submit
documentation to FDA, including the
number of their employees, as well as
information that their application is
their first human drug application,
within the meaning of the FD&C Act, to
be submitted to the Agency for
approval.
We estimate receiving 22 requests for
reconsideration annually (including
small business waiver reconsiderations)
and assume the average burden for
preparing and submitting each request
is 24 hours. In addition, we estimate
receiving six requests annually for
appeal of user fee waiver
determinations, and assume the time
needed to prepare an appeal is 12 hours.
We have included in this estimate both
the time needed to prepare the request
for appeal to the Chief Scientist and
User Fee Appeals Officer within the
Office of the Commissioner, and the
time needed to create and send a copy
of the request for an appeal to the
Director Division of User Fee
Management within the Office of
Management at FDA’s Center for Drug
Evaluation and Research.
We assume a total of 82 hours of
burden for completing and submitting
the 164 forms FDA 3397 (Prescription
Drug User Fee Coversheet) along with
submission of NDAs or BLAs. The
burdens associated with submission of
NDAs and BLAs are included in OMB
control numbers 0910–0001 and 0910–
0338, respectively.
The information collection reflects
changes and adjustments. We have
clarified that the scope of the collection
includes provisions found in our
current commitment goals letter,
negotiated with industry, pertaining to
the assessment of fees, waivers, refunds,
and exemptions under PDUFA VII.
Cumulatively these changes and
adjustments have resulted in an increase
of three responses and 203 burden hours
annually since the prior renewal of the
information collection. We attribute this
to the steady state of incoming requests
for waivers and reconsiderations and
normal fluctuations in types of
submissions or waivers received.
Dated: October 30, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26801 Filed 11–15–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Generic
Information Collection Request for
Health Resources and Services
Administration Hotlines, Chatlines, and
Online Portals
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than January 17, 2025.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Generic Information Collection Request
for Collections Related to HRSA
Hotlines, Chatlines, and Online Portals,
OMB No. 0906–New.
Abstract: HRSA currently administers
approximately 15 hotlines, chatlines,
and online portals for use by customers,
members of the public, and HRSA
funding recipients. These hotlines,
chatlines, and online portals are
administered by HRSA or a contractor
on behalf of HRSA. The purpose of
information collections under this
generic umbrella ICR package is to allow
HRSA to collect information on the
operation of such HRSA hotlines,
chatlines, and online portals to assist
SUMMARY:
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HRSA in improving their operation and
determining if these services are
helpful. In addition to collecting basic
demographic information, the
information collections would include
questions such as reasons for inquiry,
topics covered by inquiry, feedback on
provided guidance or the hotline/
chatline/online portal user experience.
No protected information, such as
personal health information or trade
secrets, will be disclosed unless
specifically required by law.
An illustrative, but not exhaustive,
list of examples of information
collection activities that would fall
under this collection include
standardized questions that are asked
during the interaction with the public;
surveys about their interaction; and
information collected about their
experience in use of hotlines, chatlines,
and online portals. This generic
umbrella ICR covers responses to
standardized and survey questions
relating to public use of HRSA’s
hotlines, chatlines, and online portals,
pursuant to the ‘‘Social Media, WebBased Interactive Technologies, and the
Paperwork Reduction Act’’ 2010 White
House guidance memo. The memo can
be found at: https://
www.whitehouse.gov/wp-content/
uploads/legacy_drupal_files/omb/
assets/inforeg/SocialMediaGuidance_
04072010.pdf.
Need and Proposed Use of the
Information: The purpose of collections
under this generic umbrella ICR is for
accountability, program management,
and oversight purposes. Collecting
feedback from members of the public
about their interaction with these
services will help ensure that HRSA
hotlines, chatlines, and online portals
are operating to the best of their
abilities. While HRSA can evaluate the
general need for and the overall
practical utility of such information
collection in advance, HRSA is unable
to determine the details of the specific
individual collection methodologies
until a later time. Using a generic
umbrella ICR will allow HRSA to
quickly and nimbly respond to public
needs and efficiently provide vital
services to grantees and the general
public, as the standard 6 to 9 month
timeline to comply with a full request
under the Paperwork Reduction Act
could inhibit HRSA’s ability to collect
information to inform these activities
that involve rapid updates to be
responsive to their users. The
information collected is expected to be
voluntary and low-burden. Therefore, a
generic umbrella ICR clearance is
requested to allow for quick turnaround
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]]>Agencies
[Federal Register Volume 89, Number 222 (Monday, November 18, 2024)]
[Notices]
[Pages 90705-90708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26801]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4467]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug User Fee Program
AGENCY: Food and Drug Administration, HHS.
[[Page 90706]]
ACTION: Notice.
-----------------------------------------------------------------------
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 information collection associated with
FDA's Prescription Drug User Fee program.
DATES: Either electronic or written comments on the collection of
information must be submitted by January 17, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 17, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2024-N-4467 for ``Prescription Drug User Fee Program.'' 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Prescription Drug User Fee Program
OMB Control Number 0910-0297--Revision
This information collection supports implementation of the FDA
Prescription Drug User Fee program (called ``PDUFA'' in reference to
the Prescription Drug User Fee Act). Under the prescription drug user
fee provisions of the Federal Food, Drug, and Cosmetic
[[Page 90707]]
Act (FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), we
have the authority to assess and collect annual program fees for
prescription drug products approved under certain new drug applications
(NDAs) and biologics license applications (BLAs). Also under this
authority, pharmaceutical companies pay an application fee for certain
NDAs and BLAs submitted to FDA for review. Because the submission of
user fees concurrently with applications is required, review of an
application by FDA cannot begin until the fee is submitted.
PDUFA must be reauthorized every 5 years. On September 30, 2022,
the President signed into law the FDA User Fee Reauthorization Act of
2022, which includes the reauthorization of PDUFA through September 30,
2027 (https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027). PDUFA VII provides for
the continued timely review of NDAs and BLAs. Since the initial passage
of PDUFA, user fees have played an important role in expediting the
drug review and approval process. PDUFA VII reauthorization also
includes commitments to meet certain performance goals and procedures.
The commitment goals represent the product of FDA's discussions with
the regulated industry and public stakeholders, as mandated by
Congress.
We are revising the collection to include our current commitment
goals, as set forth in the document ``PDUFA Reauthorization Performance
Goals and Procedures Fiscal Years 2023 Through 2027,'' found on our
website at https://www.fda.gov/media/151712/download?attachment. The
commitment goals represent the product of FDA's discussions with the
regulated industry and public stakeholders, as mandated by Congress.
FDA is committed to meeting these goals and to continuous operational
improvements associated with PDUFA implementation. The commitment goals
provide for the development and issuance of topic-specific guidance. We
maintain a searchable guidance database on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. In
publishing the respective notices of availability for each guidance
document, we include an analysis under the PRA and invite public
comment on the associated information collection recommendations. In
addition, all Agency guidance documents are issued in accordance with
our Good Guidance Practices regulations in 21 CFR 10.115, which provide
for public comment at any time.
To assist respondents with the information collection, we developed
Form FDA 3397 entitled ``Prescription Drug User Fee Cover Sheet.''
Additional information and associated instructions may be found on our
website at https://www.fda.gov/industry/fda-user-fee-programs. The
cover sheet (Form FDA 3397) is submitted for original NDAs, BLAs and
resubmissions of these original applications after withdrawal before
filing or refusal to file actions. The form is not submitted for
certain FDA-regulated products. The list of exempted products is
included under the instructions to Form FDA 3397.
Relatedly, sections 735 and 736 of the FD&C Act also provide for
waiver, reduction, exemption and refund requests. We developed the
guidance document entitled ``Guidance for Industry--Prescription Drug
User Fee Act Waivers, Reductions, and Refunds for Drug and Biological
Products,'' and Form FDA 3971 (Small Business Waiver and Refund
Request), which can be found on our website at https://www.fda.gov/media/131797/download, as mandated by Congress.
We also developed Form FDA 4068, ``Prescription Drug User Fee Act;
Waivers, Refunds, and Exemptions,'' along with accompanying
instructions, to enable sponsors of designated orphan products to
request an exemption from applicable fees under PDUFA and included the
form in the information collection when the prior renewal was submitted
for approval. Use of the form will provide the information required for
analysis and application of the orphan exemption from user fees,
organizing the requested information for easier data collection and
streamlining the review request. We find, however, with this renewal,
that use of the form has not been implemented yet, pending development
of the OneNexus system for management of the user fee systems. Use of
the form is anticipated once the OneNexus system is developed and
implemented for the PDUFA program.
The PDUFA information collection and all user fee cover sheets,
including the ``Prescription Drug User Fee Cover Sheet'' (Form FDA
3397), are accessed and submitted electronically, as required by
statute, through FDA's electronic systems such as the Document
Archiving Reporting and Regulatory Tracking System (DARRTS), Electronic
Submission Gateway (ESG), and Panorama.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Prescription drug user fee Number of responses per Total annual Average burden per Total
activity respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Sections 735 and 736 of the 99 1.828 181 17....................... 3,077
FD&C Act (PDUFA waivers and
exemptions, not including
small business waiver
requests).
Section 736(d)(1)(C) of the 35 1 35 2........................ 70
FD&C Act and Form FDA 3971
(small business waivers).
Reconsideration Requests....... 13 1.69 22 24....................... 528
Appeal Requests................ 4 1.5 6 12....................... 72
User Fee Cover Sheet Form FDA 132 1.24 164 0.5 (30 minutes)......... 82
3397 submission with original
NDAs and BLAs.
--------------------------------------------------------------------------------
Total...................... ........... .............. 408 ......................... 3,829
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of Agency records, we estimate that the number of
initial waiver requests submitted annually (excluding small business
waiver requests under section 736(d)(1)(C)) of the FD&C Act) is 181,
submitted by 99 different applicants.
We estimate that 35 respondents will each submit a small business
waiver request annually. We have included in the burden estimate the
time for preparation and submission of application fee waivers for
small businesses, including completion of Form FDA 3971. Small
businesses
[[Page 90708]]
requesting a waiver must submit documentation to FDA, including the
number of their employees, as well as information that their
application is their first human drug application, within the meaning
of the FD&C Act, to be submitted to the Agency for approval.
We estimate receiving 22 requests for reconsideration annually
(including small business waiver reconsiderations) and assume the
average burden for preparing and submitting each request is 24 hours.
In addition, we estimate receiving six requests annually for appeal of
user fee waiver determinations, and assume the time needed to prepare
an appeal is 12 hours. We have included in this estimate both the time
needed to prepare the request for appeal to the Chief Scientist and
User Fee Appeals Officer within the Office of the Commissioner, and the
time needed to create and send a copy of the request for an appeal to
the Director Division of User Fee Management within the Office of
Management at FDA's Center for Drug Evaluation and Research.
We assume a total of 82 hours of burden for completing and
submitting the 164 forms FDA 3397 (Prescription Drug User Fee
Coversheet) along with submission of NDAs or BLAs. The burdens
associated with submission of NDAs and BLAs are included in OMB control
numbers 0910-0001 and 0910-0338, respectively.
The information collection reflects changes and adjustments. We
have clarified that the scope of the collection includes provisions
found in our current commitment goals letter, negotiated with industry,
pertaining to the assessment of fees, waivers, refunds, and exemptions
under PDUFA VII. Cumulatively these changes and adjustments have
resulted in an increase of three responses and 203 burden hours
annually since the prior renewal of the information collection. We
attribute this to the steady state of incoming requests for waivers and
reconsiderations and normal fluctuations in types of submissions or
waivers received.
Dated: October 30, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26801 Filed 11-15-24; 8:45 am]
BILLING CODE 4164-01-P
