[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25282-25284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

    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:
     Reorder Field 8, ``Physician Name, Address, and Contact 
Information'' to Field 1, and renumber remaining data fields 
accordingly;
     Add ``Race and Ethnicity'' as an optional item under the 
``Clinical Information/Brief Clinical History'' field;
     Add ``Request for Withdrawal'' under the ``Contents of 
Submission'' field;
     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\.
                             -----------------------------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
  Part 312, subpart I; activity      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
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\...................
                                 -------------------------------------------------------------------------------
    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