[Federal Register Volume 86, Number 237 (Tuesday, December 14, 2021)]
[Notices]
[Pages 71069-71071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/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).
    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]
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