Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use

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Published

December 14, 2021

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with expanded access to investigational drugs for treatment use.

Full Text

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<title>Federal Register, Volume 86 Issue 237 (Tuesday, December 14, 2021)</title>
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[Federal Register Volume 86, Number 237 (Tuesday, December 14, 2021)]
[Notices]
[Pages 71069-71071]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26990]

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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; Expanded Access to Investigational Drugs for Treatment
Use

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 information collection
associated with expanded access to investigational drugs for treatment
use.

DATES: Submit either electronic or written comments on the collection
of information by February 14, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 14, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 14, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
<bullet> Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3758 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Expanded Access Applications.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#550507140621343333153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="db8b899a88afbabdbd9bbdbfbaf5b3b3a8f5bcb4ad">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal

[[Page 71070]]

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.

Expanded Access to Investigational Drugs for Treatment Use

OMB Control Number 0910-0814--Revision

This information collection supports Agency regulations in 21 CFR
part 312, subpart I, Expanded Access to Investigational Drugs for
Treatment Use; associated guidance; and Form FDA 3926, Individual
Patient Expanded Access Investigational New Drug Application (IND). The
regulations govern the use of investigational new drugs, biologics, and
approved drugs if availability is limited by a risk evaluation and
mitigation strategy, when the primary purpose is to diagnose, monitor,
or treat a patient's disease or condition. The goal of the expanded
access program is to facilitate the availability of such products to
patients with serious diseases or conditions when there is no
comparable or satisfactory alternative therapy to diagnose, monitor, or
treat the patient's disease or condition. The regulations provide that
certain criteria be met, establish content and format requirements for
associated reporting, and require that submissions include a cover
sheet.
Although we continue to account for burden associated with the
submission of expanded access requests for individual patients, we are
revising the information collection to also account for burden
attendant to other expanded access submissions, including commercial
investigational new drug applications (INDs) that involve large groups
of patients enrolled for treatment use of the investigational drug
(Sec. Sec. 312.300 through 312.320 (21 CFR 312.300 through 312.320)),
currently approved under OMB control number 0910-0014. Because of FDA's
long history of facilitating expanded access to investigational drugs
for treatment use for patients with serious or immediately life-
threatening diseases or conditions, our efforts in this regard are
ongoing.
Form FDA 3926 was developed to assist respondents to the
information collection. Form FDA 3926 requires the completion of data
fields that enable us to uniformly collect the minimum information
necessary from licensed physicians who want to request expanded access
as prescribed in the applicable regulations. To supplement the form
instructions, we issued guidance, most recently updated in October
2017, entitled ``Individual Patient Expanded Access Applications: Form
FDA 3926,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/individual-patient-expanded-access-applications-form-fda-3926">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/individual-patient-expanded-access-applications-form-fda-3926</a>. As discussed in the guidance, Sec.
312.310(b) contains additional submission requirements for individual
patient expanded access requests. These respondents may continue to use
either Form FDA 3926 or Form FDA 1571, Investigational New Drug
Application (IND), for all types of IND submissions to satisfy
requirements in 21 CFR 312.23(a) (approved under OMB control number
0910-0014). FDA considers a completed Form FDA 3926 signed by the
physician and checked in the box in Field 10.a (Request for
Authorization to use Form FDA 3926) to be a waiver request in
accordance with 21 CFR 312.10.
We are proposing the following revisions to data elements in Form
FDA 3926 and will make corresponding revisions to the form
instructions:
<bullet> Reorder Field 8, ``Physician Name, Address, and Contact
Information'' to Field 1, and renumber remaining data fields
accordingly;
<bullet> Add ``Race and Ethnicity'' as an optional item under the
``Clinical Information/Brief Clinical History'' field;
<bullet> Add ``Request for Withdrawal'' under the ``Contents of
Submission'' field;
<bullet> Add technological enhancements to the electronic version
of Form FDA 3926 that utilize user-based selections to prompt required
data field entries. Currently, certain fields become grayed out if not
required for the submission type selected.
Data elements in Sec. Sec. 312.315 and 312.320 continue to be
reported in Forms FDA 1571 and 1572, Statement of Investigator,
(approved under OMB control number 0910-0014).
We estimate the burden of the information collection as follows:

Table 1--Estimated Annual Reporting Burden--Center for Drug Evaluation and Research \1\
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Number of
21 CFR part 312, subpart I; Number of responses per Total annual Average burden Total hours
information collection activity respondents respondent responses per response
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Sec. Sec. 312.310(b) and 1,204 2.4958 3,005 * 0.75 2,254
312.305(b); submissions related
to expanded access and
treatment of an individual
patient: Form FDA 3926.........
Sec. 312.310(d); submissions 1,265 2.843 3,596 16 57,536
related to emergency use of an
investigational new drug: Form
FDA 3926.......................
Sec. Sec. 312.315(c) and 88 3.64 320 120 38,400
312.305(b); submissions related
to expanded access and
treatment of an intermediate-
size patient population \2\....
Sec. 312.320(b); submissions 20 7 140 300 42,000
related to a treatment IND or
treatment protocol \2\.........
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Total....................... .............. .............. 7,061 .............. 140,190
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Data elements are reported in Forms FDA 1571 and 1572, approved under OMB control number 0910-0014.
* (45 minutes).

[[Page 71071]]

Table 2--Estimated Annual Reporting Burden--Center for Biologics Evaluation and Research \1\
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Number of
21 CFR part 312, subpart I; Number of responses per Total annual Average burden Total hours
information collection activity respondents respondent responses per response
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Sec. Sec. 312.310(b) and 118 1.305 154 8 1,232
312.305(b); number of
submissions related to expanded
access and treatment of an
individual patient: Form FDA
3926...........................
Sec. 312.310(d); number of 1,591 4.2137 6,704 16 107,264
submissions related to
emergency use of an
investigational new drug: Form
FDA 3926.......................
Sec. Sec. 312.315(c) and 28 1 28 120 3,360
312.305(b); number of
submissions related to expanded
access and treatment of an
intermediate-size patient
population \2\.................
Sec. 312.320(b); number of 15 1 15 300 4,500
submissions related to a
treatment IND or treatment
protocol \2\...................
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Total....................... .............. .............. 6,901 .............. 116,356
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Data elements are reported in Forms FDA 1571 and 1572, approved under OMB control number 0910-0014.

The information collection reflects an increase in 254,750 burden
hours and 11,568 responses annually since the last OMB review and
approval of the information collection. We attribute this to an
increase in the number of submission.

Dated: December 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26990 Filed 12-13-21; 8:45 am]
BILLING CODE 4164-01-P

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