[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55723-55726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24321]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3758]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Individual Patient Expanded Access Applications: Form
FDA 3926
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on individual patient expanded
access applications.
DATES: Submit either electronic or written comments on the collection
of information by January 7, 2019.
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 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 7, 2019. 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
[[Page 55724]]
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-2018-N-3758 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry on
Individual Patient Expanded Access Applications: Form FDA 3926.''
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.
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.gpo.gov/fdsys/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.
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. 3501-3520), 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.
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.''
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
[[Page 55725]]
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 follow-up 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
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 follow-up/additional
submissions), including the type of submission being made. FDA accepts
Form FDA 3926 for certain follow-up/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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Guidance on Individual Patient Expanded Number of responses per Total annual Average burden per response Total hours
Access Applications: Form FDA 3926 respondents respondent responses
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Expanded access submission elements included 790 3.03 2,394 0.75 (45 mins.).......................... 1,795
in Form FDA 3926.
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\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.
[[Page 55726]]
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
follow-up 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: October 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24321 Filed 11-6-18; 8:45 am]
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