Notice2022-09070
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
Primary source
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Published
April 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) 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.
Full Text
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<title>Federal Register, Volume 87 Issue 82 (Thursday, April 28, 2022)</title>
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[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25282-25284]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09070]
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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; 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 or we) 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: Submit written comments (including recommendations) on the
collection of information by May 31, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0814. Also include the FDA docket
number found in brackets in the heading of this document.
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#045456455770656262446260652a6c6c772a636b72"><span class="__cf_email__" data-cfemail="613133203215000707210705004f0909124f060e17">[email protected]</span></a>.
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.
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 https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/
[[Page 25283]]
individual-patient-expanded-access-applications-form-fda-3926. 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).
In the Federal Register of December 14, 2021 (86 FR 71069), 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--Center for Drug Evaluation and Research \1\
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Number of
Part 312, subpart I; Number of responses per Total annual Average burden per Total hours
activity respondents respondent responses 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 (45 minutes)......
related to expanded access
and treatment of an
individual patient: Form
FDA 3926.
Sec. 312.310(d); 1,265 2.843 3,596 16................ 57,536
submissions 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); 20 7 140 300............... 42,000
submissions 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.
Table 2--Estimated Annual Reporting Burden--Center for Biologics Evaluation and Research \1\
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Number of
Part 312, subpart I; activity Number of responses per Total annual Average burden Total hours
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.
[[Page 25284]]
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 submissions.
Dated: April 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09070 Filed 4-27-22; 8:45 am]
BILLING CODE 4164-01-P
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