Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Individual Patient Expanded Access Applications, 16022-16023 [2019-07711]
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16022
Federal Register / Vol. 84, No. 74 / Wednesday, April 17, 2019 / Notices
One additional State has enrolled in
the program since 2016. The total
estimated burden of this collection has
increased to 41,667 hours among 43
respondents, from a previous total of
15,792 hours among 42 respondents.
This increase is due to a change in the
self-reported response times provided
by the respondents. Because this is a
long-term program, we believe this
change is the result of more precise
documentation by participating agencies
as they have grown more experienced
over time.
Dated: April 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07706 Filed 4–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3758]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Individual Patient
Expanded Access Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 17,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0814. Also
include the FDA docket number found
in brackets in the heading of this
document.
amozie on DSK9F9SC42PROD with NOTICES
ADDRESSES:
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.
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18:23 Apr 16, 2019
Jkt 247001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry on Individual
Patient Expanded Access Applications:
Form FDA 3926
OMB Control Number 0910–0814—
Extension
This information collection supports
Agency regulations, associated
guidance, and Form FDA 3926
concerning individual patient expanded
access. Individual patient expanded
access allows an individual patient who
has a serious or immediately lifethreatening disease or condition and
there is no comparable or satisfactory
alternative therapy to diagnose, monitor,
or treat the disease or condition, the use
of an investigational new drug (IND)
outside of a clinical investigation, or the
use of an approved drug where
availability is limited by a risk
evaluation and mitigation strategy.
When applicable criteria in § 312.305(a)
(21 CFR 312.305(a)) (which apply to all
types of expanded access) and the
criteria in § 312.310(a) (21 CFR
312.310(a)) (which apply specifically to
individual patient expanded access,
including for emergency use) are met,
FDA may permit expanded access.
Section 312.305(b) sets forth the
submission requirements for all types of
expanded access requests. To assist
respondents with requirements in
§ 312.305, we developed Form FDA
3926 (Individual Patient Expanded
Access Investigational New Drug
Application) and the guidance
document entitled, ‘‘Individual Patient
Expanded Access Applications: Form
FDA 3926,’’ which are available at
https://www.fda.gov/AboutFDA/Reports
ManualsForms/Forms/default.htm and
https://www.fda.gov/downloads/drugs/
guidancecomplianceregulatory
information/guidances/ucm432717.pdf,
respectively.
The physician may satisfy some of the
submission requirements by referring to
information in an existing IND,
ordinarily the one held by the
investigational drug’s manufacturer, if
the physician obtains permission from
that IND holder. If permission is
obtained, the physician should then
provide to FDA a letter of authorization
(LOA) from the existing IND holder that
permits FDA to reference that IND.
One of the requirements under
§ 312.305(b)(2) is that a ‘‘cover sheet’’
must be included ‘‘meeting the
requirements of § 312.23(a).’’ This
provision applies to several types of
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
submissions under part 312 (21 CFR
part 312), ranging from commercial
INDs under § 312.23 that involve large
groups of patients enrolled in clinical
trials to requests from physicians to use
an investigational drug for an individual
patient. Sponsors currently use Form
FDA 1571 for all types of IND
submissions to meet the requirements in
§ 312.23(a).
Concerned that physicians requesting
expanded access for an individual
patient may encounter difficulty in
completing Form FDA 1571 and the
associated documents because the form
is not tailored to requests for individual
patient expanded access, we developed
Form FDA 3926 to comply with the IND
submission requirements in §§ 312.23,
312.305(b), and 312.310(b). Form FDA
3926 provides a streamlined means to
request expanded access and is
available for licensed physicians. FDA
considers a completed Form FDA 3926
with the box in Field 10 checked and
the form signed by the physician to be
a request in accordance with § 312.10
for a waiver of any additional
requirements in part 312 for an IND
submission, including additional
information currently provided in Form
FDA 1571 and Form FDA 1572
(Statement of Investigator, which
provides the identity and qualifications
of the investigator conducting the
clinical investigation).
Under § 312.310(d), in an emergency
situation that requires the patient to be
treated before a written submission can
be made, the request to use the
investigational drug for individual
patient expanded access may be made
by telephone (or other rapid means of
communication) to the appropriate FDA
review division. Authorization of the
emergency use may be given by an FDA
official over the telephone, provided the
physician explains how the expanded
access use will meet the requirements of
§§ 312.305 and 312.310 and agrees to
submit an expanded access application
within 15 working days of FDA’s initial
authorization of the expanded access
use (§ 312.310(d)). The physician may
choose to use Form FDA 3926 for the
expanded access application.
As explained in the instructions for
Form FDA 3926 and discussed in the
guidance document, the following
information is submitted to FDA:
• Initials for the patient and date of
submission.
• Type of submission (initial or
followup submission).
• Clinical information, including
indication, brief clinical history of the
patient (age, gender, weight, allergies,
diagnosis, prior therapy, response to
prior therapy), and the reason for
E:\FR\FM\17APN1.SGM
17APN1
16023
Federal Register / Vol. 84, No. 74 / Wednesday, April 17, 2019 / Notices
requesting the proposed treatment,
including an explanation of why the
patient lacks other therapeutic options.
• Treatment information, including
the investigational drug’s name and the
name of the entity supplying the drug
(generally the manufacturer), the
applicable FDA review division (if
known), and the treatment plan. This
should include the planned dose, route
and schedule of administration, planned
duration of treatment, monitoring
procedures, and planned modifications
to the treatment plan in the event of
toxicity.
• LOA, generally obtained from the
entity that is the sponsor of the IND
(e.g., commercial sponsor/drug
manufacturer) being referenced, if
applicable.
• Physician’s qualification statement.
An appropriate statement includes
medical school attended, year of
graduation, medical specialty, State
medical license number, current
employment, and job title.
Alternatively, the relevant portion of the
physician’s curriculum vitae may be
attached.
• Physician’s contact information,
including name, physical address, email
address, telephone number, facsimile
number, and physician’s IND number, if
previously issued by FDA.
• Contents of submission (for
followup/additional submissions),
including the type of submission being
made. FDA accepts Form FDA 3926 for
certain followup/additional
submissions, which include the
following: Initial written IND safety
report (§ 312.32(c)); followup to a
written IND safety report (§ 312.32(d));
annual report (§ 312.33); summary of
expanded access use (treatment
completed) (§ 312.310(c)(2)); change in
treatment plan (§ 312.30); general
correspondence or response to FDA
request for information (§ 312.41); and
response to clinical hold (§ 312.42(e)).
• Request for authorization to use
Form FDA 3926 for individual patient
expanded access application.
• Signature of the physician
certifying that treatment will not begin
until 30 days after FDA receives the
completed application and all required
material unless the submitting
physician receives earlier notification
from FDA that the treatment may
proceed. The physician agrees not to
begin or continue clinical investigations
covered by the IND if those studies are
placed on clinical hold. The physician
also certifies that informed consent will
be obtained in compliance with Federal
requirements (including FDA’s
regulations in 21 CFR part 50) and that
an institutional review board (IRB) that
complies with all Federal requirements
(including FDA’s regulations in 21 CFR
part 56) will be responsible for initial
and continuing review and approval of
the expanded access use. The physician
also acknowledges that in the case of an
emergency request, treatment may begin
without prior IRB approval, provided
the IRB is notified of the emergency
treatment within 5 working days of
treatment. The physician agrees to
conduct the investigation in accordance
with all other applicable regulatory
requirements.
In the Federal Register of November
7, 2018 (83 FR 55723), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance on individual patient expanded access
applications: Form FDA 3926
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Expanded access submission elements included in Form
FDA 3926 .........................................................................
790
3.03
2,394
0.75 (45
mins.)
amozie on DSK9F9SC42PROD with NOTICES
1 There
Total hours
1,795
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we are retaining the
currently approved burden estimate.
The estimates for ‘‘number of
respondents,’’ ‘‘number of responses per
respondent,’’ and ‘‘total annual
responses’’ were obtained from reports
and data management systems from the
Center for Drug Evaluation and Research
(CDER) and from other sources familiar
with the number of submissions
received for individual patient
expanded access use under part 312.
The estimates for ‘‘average burden per
response’’ were based on information
CDER provided and personnel of the
U.S. Department of Health and Human
Services familiar with preparing and
reviewing expanded access submissions
by practicing physicians.
Based on data from the Document
Archiving, Reporting, and Regulatory
Tracking System for the number of
submissions to FDA using FDA Form
3926 during fiscal years 2015, 2016, and
2017, we estimate that approximately
VerDate Sep<11>2014
18:23 Apr 16, 2019
Jkt 247001
790 licensed physicians would use FDA
Form 3926 to submit 1.46 requests per
physician (respondent) for individual
patient expanded access, for a total of
1,153 responses annually. Based on
these estimates, FDA calculates the total
annual responses to be 2,394 (1,153
requests for individual patient
expanded access and 1,241 followup
submissions) by 790 physicians for an
average of 3.03 responses per
respondent. FDA estimates the average
burden per response to be 45 minutes
(0.75 hour). Based on this estimate, FDA
calculates the total burden to be 1,795
hours.
Dated: April 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07711 Filed 4–16–19; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0001]
Advancing the Development and
Implementation of Analysis Data
Standards: Key Challenges and
Opportunities; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Advancing the Development and
Implementation of Analysis Data
Standards: Key Challenges and
Opportunities.’’ Convened by the DukeRobert J. Margolis Center for Health
Policy at Duke University in partnership
with the Critical Path Institute and
supported by a cooperative agreement
SUMMARY:
E:\FR\FM\17APN1.SGM
17APN1
Agencies
[Federal Register Volume 84, Number 74 (Wednesday, April 17, 2019)]
[Notices]
[Pages 16022-16023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07711]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3758]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Individual Patient
Expanded Access Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 17,
2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0814.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Individual Patient Expanded Access
Applications: Form FDA 3926
OMB Control Number 0910-0814--Extension
This information collection supports Agency regulations, associated
guidance, and Form FDA 3926 concerning individual patient expanded
access. Individual patient expanded access allows an individual patient
who has a serious or immediately life-threatening disease or condition
and there is no comparable or satisfactory alternative therapy to
diagnose, monitor, or treat the disease or condition, the use of an
investigational new drug (IND) outside of a clinical investigation, or
the use of an approved drug where availability is limited by a risk
evaluation and mitigation strategy. When applicable criteria in Sec.
312.305(a) (21 CFR 312.305(a)) (which apply to all types of expanded
access) and the criteria in Sec. 312.310(a) (21 CFR 312.310(a)) (which
apply specifically to individual patient expanded access, including for
emergency use) are met, FDA may permit expanded access.
Section 312.305(b) sets forth the submission requirements for all
types of expanded access requests. To assist respondents with
requirements in Sec. 312.305, we developed Form FDA 3926 (Individual
Patient Expanded Access Investigational New Drug Application) and the
guidance document entitled, ``Individual Patient Expanded Access
Applications: Form FDA 3926,'' which are available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm and https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm432717.pdf, respectively.
The physician may satisfy some of the submission requirements by
referring to information in an existing IND, ordinarily the one held by
the investigational drug's manufacturer, if the physician obtains
permission from that IND holder. If permission is obtained, the
physician should then provide to FDA a letter of authorization (LOA)
from the existing IND holder that permits FDA to reference that IND.
One of the requirements under Sec. 312.305(b)(2) is that a ``cover
sheet'' must be included ``meeting the requirements of Sec.
312.23(a).'' This provision applies to several types of submissions
under part 312 (21 CFR part 312), ranging from commercial INDs under
Sec. 312.23 that involve large groups of patients enrolled in clinical
trials to requests from physicians to use an investigational drug for
an individual patient. Sponsors currently use Form FDA 1571 for all
types of IND submissions to meet the requirements in Sec. 312.23(a).
Concerned that physicians requesting expanded access for an
individual patient may encounter difficulty in completing Form FDA 1571
and the associated documents because the form is not tailored to
requests for individual patient expanded access, we developed Form FDA
3926 to comply with the IND submission requirements in Sec. Sec.
312.23, 312.305(b), and 312.310(b). Form FDA 3926 provides a
streamlined means to request expanded access and is available for
licensed physicians. FDA considers a completed Form FDA 3926 with the
box in Field 10 checked and the form signed by the physician to be a
request in accordance with Sec. 312.10 for a waiver of any additional
requirements in part 312 for an IND submission, including additional
information currently provided in Form FDA 1571 and Form FDA 1572
(Statement of Investigator, which provides the identity and
qualifications of the investigator conducting the clinical
investigation).
Under Sec. 312.310(d), in an emergency situation that requires the
patient to be treated before a written submission can be made, the
request to use the investigational drug for individual patient expanded
access may be made by telephone (or other rapid means of communication)
to the appropriate FDA review division. Authorization of the emergency
use may be given by an FDA official over the telephone, provided the
physician explains how the expanded access use will meet the
requirements of Sec. Sec. 312.305 and 312.310 and agrees to submit an
expanded access application within 15 working days of FDA's initial
authorization of the expanded access use (Sec. 312.310(d)). The
physician may choose to use Form FDA 3926 for the expanded access
application.
As explained in the instructions for Form FDA 3926 and discussed in
the guidance document, the following information is submitted to FDA:
Initials for the patient and date of submission.
Type of submission (initial or followup submission).
Clinical information, including indication, brief clinical
history of the patient (age, gender, weight, allergies, diagnosis,
prior therapy, response to prior therapy), and the reason for
[[Page 16023]]
requesting the proposed treatment, including an explanation of why the
patient lacks other therapeutic options.
Treatment information, including the investigational
drug's name and the name of the entity supplying the drug (generally
the manufacturer), the applicable FDA review division (if known), and
the treatment plan. This should include the planned dose, route and
schedule of administration, planned duration of treatment, monitoring
procedures, and planned modifications to the treatment plan in the
event of toxicity.
LOA, generally obtained from the entity that is the
sponsor of the IND (e.g., commercial sponsor/drug manufacturer) being
referenced, if applicable.
Physician's qualification statement. An appropriate
statement includes medical school attended, year of graduation, medical
specialty, State medical license number, current employment, and job
title. Alternatively, the relevant portion of the physician's
curriculum vitae may be attached.
Physician's contact information, including name, physical
address, email address, telephone number, facsimile number, and
physician's IND number, if previously issued by FDA.
Contents of submission (for followup/additional
submissions), including the type of submission being made. FDA accepts
Form FDA 3926 for certain followup/additional submissions, which
include the following: Initial written IND safety report (Sec.
312.32(c)); followup to a written IND safety report (Sec. 312.32(d));
annual report (Sec. 312.33); summary of expanded access use (treatment
completed) (Sec. 312.310(c)(2)); change in treatment plan (Sec.
312.30); general correspondence or response to FDA request for
information (Sec. 312.41); and response to clinical hold (Sec.
312.42(e)).
Request for authorization to use Form FDA 3926 for
individual patient expanded access application.
Signature of the physician certifying that treatment will
not begin until 30 days after FDA receives the completed application
and all required material unless the submitting physician receives
earlier notification from FDA that the treatment may proceed. The
physician agrees not to begin or continue clinical investigations
covered by the IND if those studies are placed on clinical hold. The
physician also certifies that informed consent will be obtained in
compliance with Federal requirements (including FDA's regulations in 21
CFR part 50) and that an institutional review board (IRB) that complies
with all Federal requirements (including FDA's regulations in 21 CFR
part 56) will be responsible for initial and continuing review and
approval of the expanded access use. The physician also acknowledges
that in the case of an emergency request, treatment may begin without
prior IRB approval, provided the IRB is notified of the emergency
treatment within 5 working days of treatment. The physician agrees to
conduct the investigation in accordance with all other applicable
regulatory requirements.
In the Federal Register of November 7, 2018 (83 FR 55723), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Guidance on individual patient expanded access applications: Form Number of responses per Total annual Average burden Total hours
FDA 3926 respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expanded access submission elements included in Form FDA 3926...... 790 3.03 2,394 0.75 (45 mins.) 1,795
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, we are retaining
the currently approved burden estimate. The estimates for ``number of
respondents,'' ``number of responses per respondent,'' and ``total
annual responses'' were obtained from reports and data management
systems from the Center for Drug Evaluation and Research (CDER) and
from other sources familiar with the number of submissions received for
individual patient expanded access use under part 312. The estimates
for ``average burden per response'' were based on information CDER
provided and personnel of the U.S. Department of Health and Human
Services familiar with preparing and reviewing expanded access
submissions by practicing physicians.
Based on data from the Document Archiving, Reporting, and
Regulatory Tracking System for the number of submissions to FDA using
FDA Form 3926 during fiscal years 2015, 2016, and 2017, we estimate
that approximately 790 licensed physicians would use FDA Form 3926 to
submit 1.46 requests per physician (respondent) for individual patient
expanded access, for a total of 1,153 responses annually. Based on
these estimates, FDA calculates the total annual responses to be 2,394
(1,153 requests for individual patient expanded access and 1,241
followup submissions) by 790 physicians for an average of 3.03
responses per respondent. FDA estimates the average burden per response
to be 45 minutes (0.75 hour). Based on this estimate, FDA calculates
the total burden to be 1,795 hours.
Dated: April 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07711 Filed 4-16-19; 8:45 am]
BILLING CODE 4164-01-P