Notice2023-09982
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 10, 2023
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 88 Issue 90 (Wednesday, May 10, 2023)</title>
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[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30131-30133]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09982]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1661]
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
[[Page 30132]]
(OMB) for review and clearance under the Paperwork Reduction Act of
1995.
DATES: Submit written comments (including recommendations) on the
collection of information by June 9, 2023.
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#104042514364717676507674713e7878633e777f66"><span class="__cf_email__" data-cfemail="a7f7f5e6f4d3c6c1c1e7c1c3c689cfcfd489c0c8d1">[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
Sometimes called ``compassionate use,'' expanded access (EA) is a
potential pathway for a patient with a serious or immediately life-
threatening disease or condition to gain access to an investigational
medical product (drug, biologic, or medical device) for treatment
outside of clinical trials when no comparable or satisfactory
alternative therapy options are available. Agency regulations in 21 CFR
part 312 provide for individual patient EA and associated procedures
for those submitting EA requests to FDA. We provide resource
information on our website at <a href="https://www.fda.gov/news-events/public-health-focus/expanded-access">https://www.fda.gov/news-events/public-health-focus/expanded-access</a> regarding our EA program, including
information for patients, physicians, and industry. We also provide
information pertaining to forms and processes for submitting EA
requests to FDA. Specifically, we have developed electronic Form FDA
3926 ``Individual Patient Expanded Access Investigational New Drug
Application (IND).'' Upon accessing the online form, users may need to
follow certain technical instructions to save the document in a
portable document format (PDF). Form FDA 3926 requires the completion
of data fields that enable FDA to uniformly collect the minimum
information necessary from licensed physicians who want to request EA
as prescribed in the applicable regulations.
Description of Respondents: Respondents to the collection of
information are licensed physicians who request individual patient
access to investigational drugs.
In the Federal Register of December 14, 2021 (86 FR 71069), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. However, on our
own initiative, we are proposing the following revisions to associated
Form FDA 3926:
Table 1--Summary of Proposed Data Field Changes to Form FDA 3926
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Includes proposed With accompanying instruction
Current field: changes to: Becoming new field: to:
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8. Physician Name, Address, Delete ``Physician's 1. Physician Name, Enter the physician's name, name
and Contact Information. IND number, if Name of Institution of institution or clinical
known'' from this or Clinical Practice, practice, and the physician's
field and move to Address, and Contact contact information, including
proposed Field 4.a. Information. the physical address, email
Add ``Name of Remaining fields address, telephone number, and
Institution or become renumbered. facsimile (FAX) number.
Clinical Practice''
to the title of the
field.
3.a. Initial Submission....... Add ``enter the 4.a. Initial If the submission is an initial
Physician's IND Submission. (original) submission for an
Number, if previously [ballot] Select this individual patient expanded
issued by FDA,''. box if this form is access IND (including for
an initial submission emergency use), select the box
for an individual provided in field 4.a., enter
patient expanded the physician's IND number, if
access IND, enter the previously issued by FDA, and
Physician's IND complete only fields 5 through
Number, if previously 8, and fields 10 and 11. Do not
issued by FDA, and include commercial sponsor's
complete only fields IND number.
5 through 8, and
fields 10 and 11.
4. Clinical Information....... Add ``or 5. Clinical Provide the indication (proposed
Brief Clinical History sensitivities, race Information. treatment use) and a brief
(Patient's age, gender, and ethnicity Brief Clinical History clinical history of the
weight, allergies, diagnosis, (optional)'' after (Patient's age, patient. The clinical history
prior therapy, response to allergies. gender, weight, includes age, gender, weight,
prior therapy, reason for Add ``Ethnicity (check allergies or allergies or sensitivities
request, including an one)'' and list sensitivities, race (general (e.g., soy) and drug
explanation of why the choice options and ethnicity specific) and other optional
patient lacks other (Hispanic/Latino or (optional), demographic and clinical
therapeutic options). Not Hispanic/Latino). diagnosis, prior information (e.g., race (as
Add ``Race (check all therapy, response to reported by the patient; you
that apply)'' and prior therapy, reason may choose multiple answers)
list choice options for request, and ethnicity (choose only one
(American Indian/ including an response)), diagnosis (e.g., a
Alaska Native or explanation of why brief summary (with dates) of
Asian or Black/ the patient lacks relevant past medical and
African American or other therapeutic surgical history, diagnostic
Native Hawaiian/Other options). procedures, current stage/
Pacific Islander or Ethnicity (check one). severity of disease, and
White). [ballot] Hispanic/ functional status), prior
Latino. therapy, response to prior
[ballot] Not Hispanic/ therapy (e.g., patient was
Latino. treated with drug X and
Race (check all that subsequently developed lung
apply). metastasis), and the reason for
[ballot] American requesting the proposed
Indian/Alaska Native. treatment, including an
[ballot] Asian........ explanation of why the patient
[ballot] Black or lacks other therapeutic options
African American. (e.g., patient has failed or is
[ballot] Native intolerant to currently
Hawaiian/Other available therapy, or is not
Pacific Islander. eligible for any clinical
[ballot] White........ trials registered at
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>).
[[Page 30133]]
5: Treatment Information...... Add ``(including Field 6............... Provide treatment information,
rationale for dose)''. including the investigational
Add ``(e.g., drug's name and the name of the
assessment criteria/ entity supplying the drug
procedure(s) for (generally the manufacturer),
monitoring and the applicable FDA review
frequency)''. division (if known), and a
Add ``(e.g., criteria concise statement regarding the
for adjusting dose if treatment plan. This includes
dose reduction or the planned dose, route and
escalation is schedule of administration of
planned, criteria for the investigational drug
stopping the (including rationale for dose),
treatment),''. planned duration of treatment,
Add ``(e.g., monitoring procedures (e.g.,
concomitant assessment criteria/
medication)''. procedure(s) for monitoring and
Add ``You may choose frequency), planned
to attach an modifications to the treatment
Investigator plan in the event of toxicity
Brochure, scientific (e.g., criteria for adjusting
publication(s), or dose if dose reduction or
other supporting escalation is planned, criteria
documents, if for stopping the treatment),
needed.''. and other relevant information
(e.g., concomitant medication).
The information should be
entered within the space
provided. You may choose to
attach an Investigator
Brochure, scientific
publication(s), or other
supporting documents, if
needed.
None.......................... Add a box option for 9. Contents of Field 9: Contents of Submission
``Request for Submission. (Follow-up/Additional
Withdrawal'' under ...................... Submissions Only).
``Summary of Expanded [ballot] Request for Request for Withdrawal: A
Access Use (treatment Withdrawal. submission describing the
completed)''. intent to withdraw an effective
IND (21 CFR 312.38).
None.......................... Add ``When a waiver is Field 10.b.: Request Select this box to request under
requested in this for Authorization to 21 CFR 56.105, authorization to
manner, the physician Use Alternative IRB obtain concurrence by the IRB
does not receive Review Procedures. chairperson or by a designated
notice from FDA IRB member, instead of at a
indicating that the convened IRB meeting, before
waiver is granted.''. the treatment use begins, in
order to comply with FDA's
requirements for IRB review and
approval. When a waiver is
requested in this manner, the
physician does not receive
notice from FDA indicating that
the waiver is granted.
None.......................... Add ``Information on Field 11: Field 11: Certification
where and how to Certification Statement and Signature of the
submit this form is Statement and Physician Information on where
available at Expanded Signature of the and how to submit this form is
Access--How to Physician. available at Expanded Access--
Submit''. How to Submit.
[General Instruction?]........ Insert a statement [General Instruction?] Information on where and how to
``Information on submit this form is available
where and how to at Expanded Access--How to
submit this form is Submit a Request (Forms).
available at Expanded
Access--How to Submit
a Request (Forms)''
under ``Signature of
Physician'' after
Field 11.
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We retain the currently approved burden estimate of 13,910
responses and 255,326 hours annually for the information collection. We
anticipate no adjustment as a result of the proposed form updates and
have posted a draft of revised Form FDA 3926 to the docket, available
for public inspection through <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: May 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09982 Filed 5-9-23; 8:45 am]
BILLING CODE 4164-01-P
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