[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30131-30133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[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.

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 https://www.fda.gov/news-events/public-health-focus/expanded-access 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:
----------------------------------------------------------------------------------------------------------------
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
                                                                                 ClinicalTrials.gov).

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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 https://www.regulations.gov.

    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