Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions-Drugs and Biologics, 73487-73490 [2020-25414]
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Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices
TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY—Continued
Docket No.
FDA–2020–D–1138 ....................
Center
Title of guidance
CDRH
Contact information to request single copies
Enforcement Policy for Modifications to FDA
Cleared Molecular Influenza and RSV Tests
During the Coronavirus Disease 2019
(COVID–19) Public Health Emergency (October 2020).
Although these guidances have been
implemented immediately without prior
comment, FDA will consider all
comments received and revise the
guidances as appropriate (see
§ 10.115(g)(3)).
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidances represent the current thinking
of FDA. They do not establish any rights
for any person and are not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
A. CBER Guidance
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information (listed in table 2).
CDRH—Guidance@fda.hhs.gov/.
Please include the document number 20046
and complete title of the guidance in the request.
Therefore, clearance by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501–3521) is not
required for this guidance. The
previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations and guidances have been
approved by OMB as listed in the
following table:
TABLE 2—CBER GUIDANCE AND COLLECTIONS
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
Emergency Use Authorization for Vaccines to Prevent COVID–19 (October
2020).
21
21
21
21
21
B. CDRH Guidance
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
CFR
CFR
CFR
CFR
CFR
Another guidance title referenced in
COVID–19 guidance
314.420 ......................................
part 312 .....................................
parts 210, 211, and 610 ............
part 600 .....................................
part 601 .....................................
OMB
control No(s).
..................................................................
..................................................................
..................................................................
..................................................................
..................................................................
Emergency Use Authorization of Medical
Products and Related Authorities.
information (listed in table 3).
Therefore, clearance by OMB under the
PRA is not required for this guidance.
The previously approved collections of
information are subject to review by
0910–0001
0910–0014
0910–0139
0910–0308
0910–0338
0910–0595
OMB under the PRA. The collections of
information in the following FDA
regulations have been approved by OMB
as listed in the table below.
TABLE 3—CDRH GUIDANCE AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
Another guidance title
referenced in
COVID–19 guidance
Enforcement Policy for Modifications to FDA—Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency (October
2020).
800, 801, and 809 ..................
807, subpart E ........................
820 ..........................................
N/A ..........................................
.................................................
.................................................
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IV. Electronic Access
Persons with access to the internet
may obtain COVID–19-related guidances
at:
• FDA web page entitled ‘‘COVID–19Related Guidance Documents for
Industry, FDA Staff, and Other
Stakeholders,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders;
• FDA web page entitled ‘‘Search for
FDA Guidance Documents’’ available at
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OMB
control No(s).
0910–0485
0910–0120
0910–0073
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or
• https://www.regulations.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[Docket No. FDA–2013–D–0575]
[FR Doc. 2020–25399 Filed 11–17–20; 8:45 am]
BILLING CODE 4164–01–P
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Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Expedited
Programs for Serious Conditions—
Drugs and Biologics
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices
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 revision 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 pertaining to ‘‘Expedited
Programs for Serious Conditions—Drugs
and Biologics.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 19, 2021.
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 January 19,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 19, 2021.
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.
SUMMARY:
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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
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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–D–0575 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
for Industry on Expedited Programs for
Serious Conditions—Drugs and
Biologics.’’ 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://
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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
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, PRAStaff@
fda.hhs.gov.
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 revision 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.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices
Expedited Programs for Serious
Conditions—Drugs and Biologics
OMB Control Number 0910–0765—
Extension
This information collection supports
Agency regulations and associated
guidance pertaining to expedited
programs for serious conditions. The
purpose of our regulations in 21 CFR
part 312, subpart E is to establish
procedures designed to expedite the
development, evaluation, and marketing
of new therapies intended to treat
persons with life-threatening and
severely debilitating illnesses,
especially where no satisfactory
alternative therapy exists. While the
statutory standards of safety and
effectiveness apply to all drugs, the
many kinds of drugs that are subject to
them, and the wide range of uses for
those drugs, demand flexibility in
applying the standards.
We have developed the guidance for
industry entitled ‘‘Expedited Programs
for Serious Conditions—Drugs and
Biologics’’ as a single resource for
information on FDA’s policies and
procedures related to the following
expedited programs for serious
conditions: (1) Fast track designation,
(2) breakthrough therapy designation,
(3) accelerated approval, and (4) priority
review designation. The guidance
describes threshold criteria generally
applicable to expedited programs,
including what is meant by serious
condition, unmet medical need, and
available therapy. The guidance
addresses the applicability of expedited
programs to rare diseases, clarification
on available therapy, and additional
detail on possible flexibility in
manufacturing and product quality. It
also clarifies the qualifying criteria for
breakthrough therapy designation and
provides examples of surrogate
endpoints and intermediate clinical
endpoints used to support accelerated
approval.
A sponsor or applicant who seeks fast
track designation is required to submit
to us a request showing that the drug
product: (1) Is intended for a serious or
life-threatening condition and (2) has
the potential to address an unmet
medical need. We expect that most
information to support a designation
request will have been gathered under
existing requirements for preparing an
investigational new drug (IND), new
drug application (NDA), or biologics
license application (BLA). If such
information has already been submitted
to us, the information may be
summarized in the fast track designation
request. A designation request should
include, where applicable, additional
information not specified elsewhere by
statute or regulation. For example,
additional information may be needed
to show that a product has the potential
to address an unmet medical need
where an approved therapy exists for
the serious or life-threatening condition
to be treated. Such information may
include clinical data, published reports,
summaries of data and reports, and a list
of references. The amount of
information and discussion in a
designation request need not be
voluminous, but it should be sufficient
to permit a reviewer to assess whether
the criteria for fast track designation
have been met.
After we make a fast track
designation, a sponsor or applicant may
submit a premeeting package that may
include additional information
supporting a request to participate in
certain fast track programs. The
premeeting package serves as
background information for the meeting
and should support the intended
objectives of the meeting. As with the
request for fast track designation, we
expect that most sponsors or applicants
will have gathered such information to
meet existing requirements for
preparing an IND, an NDA, or a BLA.
These may include descriptions of
clinical safety and efficacy trials not
conducted under an IND (e.g., foreign
studies) and information to support a
request for accelerated approval. If such
information has already been submitted
to us, the information may be
summarized in the premeeting package.
We also developed the guidance
document entitled ‘‘Expedited Programs
for Regenerative Medicine Therapies for
Serious Conditions.’’ The guidance
provides sponsors engaged in the
development of regenerative medicine
therapies for serious or life-threatening
diseases or conditions with FDA’s
recommendations on the expedited
development and review of these
therapies. The guidance describes the
expedited programs available to
sponsors of regenerative medicine
therapies for serious or life-threatening
diseases or conditions, including those
products designated as regenerative
advanced therapies (which FDA refers
to as ‘‘regenerative medicine advanced
therapy’’ (RMAT) designation). The
guidance also describes considerations
in the clinical development of
regenerative medicine therapies and
opportunities for sponsors of
regenerative medicine therapies to
interact with the Center of Biologics
Evaluation and Research review staff.
The guidance documents are available
on our website at www.fda.gov/
regulatory-information/search-fdaguidance-documents and were issued
consistent with our good guidance
practice regulations in 21 CFR 10.115,
which provide for public comment at
any time.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Priority Review Designation Requests ................................
Breakthrough Therapy Designation Requests .....................
Fast Track Designation Requests .......................................
RMAT Designation Requests ..............................................
Fast Track Premeeting Packages .......................................
70
119
205
33
224
1.44
1.31
1.273
1.15
1.75
101
156
261
38
392
30
70
60
60
100
3,030
10,920
15,660
2,280
39,200
Total ..............................................................................
........................
........................
948
........................
71,090
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have increased our
burden estimates by 389 responses and
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35,325 hours. As reflected in table 1, we
estimate that 70 respondents will
submit 101 requests for priority review
designation annually. We assume an
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average of 30 hours is needed to prepare
such a request.
We estimate that 119 respondents will
submit 156 requests for breakthrough
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Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices
designation annually and assume that
an average of 70 hours is needed to
prepare such a request.
We estimate 205 respondents will
submit 261 requests for fast track
designation requests annually and
assume that an average of 60 hours is
needed to prepare such a request.
Of the requests for fast track
designation made per year, we granted
approximately 224 requests from 392
respondents, and for each of these
granted requests, a premeeting package
was submitted. We therefore assume an
average burden of 100 hours per
respondent for preparing a premeeting
package.
Finally, we estimate 33 respondents
will submit 38 requests for RMAT
designation and assume that an average
of 60 hours is needed to prepare such
a request.
Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25414 Filed 11–17–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the Public
Health Service Act and the Federal
Advisory Committee Act, this notice
announces that the Advisory Committee
on Heritable Disorders in Newborns and
Children (ACHDNC or Committee) has
scheduled a public meeting to be held
on Tuesday, December 1, 2020.
Information about the ACHDNC and the
agenda for this meeting can be found on
the ACHDNC website at https://
www.hrsa.gov/advisory-committees/
heritable-disorders/.
DATES: Tuesday, December 1, 2020,
2020, from 10:00 a.m. to 2:45 p.m. ET.
ADDRESSES: This meeting will be held
via webinar. While this meeting is open
to the public, advance registration is
required. Please register online at
https://www.cvent.com/d/17qsxn by the
deadline of 12:00 p.m. ET on Monday,
November 30, 2020. Instructions on how
to access the meeting via webcast will
be provided upon registration.
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SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Alaina Harris, Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Room 18W66, Rockville,
Maryland 20857; 301–443–0721; or
ACHDNC@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACHDNC
provides advice and recommendations
to the Secretary of HHS (Secretary) on
the development of newborn screening
activities, technologies, policies,
guidelines, and programs for effectively
reducing morbidity and mortality in
newborns and children having, or at risk
for, heritable disorders. The ACHDNC
reviews and reports regularly on
newborn and childhood screening
practices, recommends improvements in
the national newborn and childhood
screening programs, and fulfills
requirements stated in the authorizing
legislation. In addition, ACHDNC’s
recommendations regarding inclusion of
additional conditions for screening,
following adoption by the Secretary, are
evidence-informed preventive health
services provided for in the
comprehensive guidelines supported by
HRSA through the Recommended
Uniform Screening Panel (RUSP)
pursuant to section 2713 of the Public
Health Service Act (42 U.S.C. 300gg–
13). Under this provision, nongrandfathered group health plans and
health insurance issuers offering group
or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
beginning on or after the date that is one
year from the Secretary’s adoption of the
condition for screening.
During the meeting, ACHDNC will
hear from experts in the fields of public
health, medicine, heritable disorders,
rare disorders, and newborn screening.
Agenda items include the following:
(1) Presentations on the decision
making criteria and matrix used to
evaluate conditions nominated to the
RUSP;
(2) review of newborn screening
implementation for the following RUSP
conditions: Severe combined
immunodeficiency (SCID), critical
congenital heart disease (CCHD), Pompe
disease, mucopolysaccharidosis type I
(MPS I), X-linked adrenoleukodystrophy
(XALD); and
(3) overview of the Review of
Newborn Screening for Spinal Muscular
Atrophy (SMA) report and vote on
whether to submit this review to the
Secretary.
In July 2018, SMA was added to the
RUSP, and the Secretary requested a
follow-up report that assesses the
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impact of implementing screening for
SMA. Following the overview of the
Review of Newborn Screening for
Spinal Muscular Atrophy report, the
Committee is expected to vote on
whether to submit this review to the
Secretary or whether further action is
warranted prior to its submission.
The agenda for this meeting does not
include any plans for recommending a
condition for inclusion in the RUSP.
Agenda items are subject to changes as
priorities dictate. Information about the
ACHDNC, including a roster of members
and past meeting summaries, are also
available on the ACHDNC website.
Members of the public also will have
the opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to provide a written statement
or make oral comments to the ACHDNC
must be submitted via the registration
website by Friday, November 27, 2020,
by 10:00 a.m. ET.
Individuals who need special
assistance or another reasonable
accommodation should notify Alaina
Harris at the address and phone number
listed above at least 10 business days
prior to the meeting.
This meeting is being announced less
than 15 days prior to the scheduled
meeting due to an administrative issue
that has now been resolved.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–25461 Filed 11–17–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Treatment and Prevention of
Neuropathic Pain With P2Y14
Antagonists
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive, sublicensable
patent license to Saint Louis University,
(‘‘SLU’’), a non-profit university located
in Missouri, in its rights to the
inventions and patents listed in the
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Pages 73487-73490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25414]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0575]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Expedited Programs for Serious Conditions--Drugs and
Biologics
AGENCY: Food and Drug Administration, HHS.
[[Page 73488]]
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 revision 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 pertaining to ``Expedited
Programs for Serious Conditions--Drugs and Biologics.''
DATES: Submit either electronic or written comments on the collection
of information by January 19, 2021.
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 January 19, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 19, 2021. 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-D-0575 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry on
Expedited Programs for Serious Conditions--Drugs and Biologics.''
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 revision 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.
[[Page 73489]]
Expedited Programs for Serious Conditions--Drugs and Biologics
OMB Control Number 0910-0765--Extension
This information collection supports Agency regulations and
associated guidance pertaining to expedited programs for serious
conditions. The purpose of our regulations in 21 CFR part 312, subpart
E is to establish procedures designed to expedite the development,
evaluation, and marketing of new therapies intended to treat persons
with life-threatening and severely debilitating illnesses, especially
where no satisfactory alternative therapy exists. While the statutory
standards of safety and effectiveness apply to all drugs, the many
kinds of drugs that are subject to them, and the wide range of uses for
those drugs, demand flexibility in applying the standards.
We have developed the guidance for industry entitled ``Expedited
Programs for Serious Conditions--Drugs and Biologics'' as a single
resource for information on FDA's policies and procedures related to
the following expedited programs for serious conditions: (1) Fast track
designation, (2) breakthrough therapy designation, (3) accelerated
approval, and (4) priority review designation. The guidance describes
threshold criteria generally applicable to expedited programs,
including what is meant by serious condition, unmet medical need, and
available therapy. The guidance addresses the applicability of
expedited programs to rare diseases, clarification on available
therapy, and additional detail on possible flexibility in manufacturing
and product quality. It also clarifies the qualifying criteria for
breakthrough therapy designation and provides examples of surrogate
endpoints and intermediate clinical endpoints used to support
accelerated approval.
A sponsor or applicant who seeks fast track designation is required
to submit to us a request showing that the drug product: (1) Is
intended for a serious or life-threatening condition and (2) has the
potential to address an unmet medical need. We expect that most
information to support a designation request will have been gathered
under existing requirements for preparing an investigational new drug
(IND), new drug application (NDA), or biologics license application
(BLA). If such information has already been submitted to us, the
information may be summarized in the fast track designation request. A
designation request should include, where applicable, additional
information not specified elsewhere by statute or regulation. For
example, additional information may be needed to show that a product
has the potential to address an unmet medical need where an approved
therapy exists for the serious or life-threatening condition to be
treated. Such information may include clinical data, published reports,
summaries of data and reports, and a list of references. The amount of
information and discussion in a designation request need not be
voluminous, but it should be sufficient to permit a reviewer to assess
whether the criteria for fast track designation have been met.
After we make a fast track designation, a sponsor or applicant may
submit a premeeting package that may include additional information
supporting a request to participate in certain fast track programs. The
premeeting package serves as background information for the meeting and
should support the intended objectives of the meeting. As with the
request for fast track designation, we expect that most sponsors or
applicants will have gathered such information to meet existing
requirements for preparing an IND, an NDA, or a BLA. These may include
descriptions of clinical safety and efficacy trials not conducted under
an IND (e.g., foreign studies) and information to support a request for
accelerated approval. If such information has already been submitted to
us, the information may be summarized in the premeeting package.
We also developed the guidance document entitled ``Expedited
Programs for Regenerative Medicine Therapies for Serious Conditions.''
The guidance provides sponsors engaged in the development of
regenerative medicine therapies for serious or life-threatening
diseases or conditions with FDA's recommendations on the expedited
development and review of these therapies. The guidance describes the
expedited programs available to sponsors of regenerative medicine
therapies for serious or life-threatening diseases or conditions,
including those products designated as regenerative advanced therapies
(which FDA refers to as ``regenerative medicine advanced therapy''
(RMAT) designation). The guidance also describes considerations in the
clinical development of regenerative medicine therapies and
opportunities for sponsors of regenerative medicine therapies to
interact with the Center of Biologics Evaluation and Research review
staff.
The guidance documents are available on our website at www.fda.gov/regulatory-information/search-fda-guidance-documents and were issued
consistent with our good guidance practice regulations in 21 CFR
10.115, which provide for public comment at any time.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Priority Review Designation 70 1.44 101 30 3,030
Requests.......................
Breakthrough Therapy Designation 119 1.31 156 70 10,920
Requests.......................
Fast Track Designation Requests. 205 1.273 261 60 15,660
RMAT Designation Requests....... 33 1.15 38 60 2,280
Fast Track Premeeting Packages.. 224 1.75 392 100 39,200
-------------------------------------------------------------------------------
Total....................... .............. .............. 948 .............. 71,090
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have increased our burden estimates by 389
responses and 35,325 hours. As reflected in table 1, we estimate that
70 respondents will submit 101 requests for priority review designation
annually. We assume an average of 30 hours is needed to prepare such a
request.
We estimate that 119 respondents will submit 156 requests for
breakthrough
[[Page 73490]]
designation annually and assume that an average of 70 hours is needed
to prepare such a request.
We estimate 205 respondents will submit 261 requests for fast track
designation requests annually and assume that an average of 60 hours is
needed to prepare such a request.
Of the requests for fast track designation made per year, we
granted approximately 224 requests from 392 respondents, and for each
of these granted requests, a premeeting package was submitted. We
therefore assume an average burden of 100 hours per respondent for
preparing a premeeting package.
Finally, we estimate 33 respondents will submit 38 requests for
RMAT designation and assume that an average of 60 hours is needed to
prepare such a request.
Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25414 Filed 11-17-20; 8:45 am]
BILLING CODE 4164-01-P
