Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use, 30131-30133 [2023-09982]
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Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices
Frequency of Response: On occasion
reporting requirement.
Obligation to Respond: Required to
obtain or retain benefits. The statutory
authority for this information collection
is contained in 154(i) of the
Communications Act of 1934, as
amended.
Total Annual Burden: 253 hours.
Total Annual Cost: None.
Needs and Uses: The information
collection requirements contained
under 47 CFR 73.1350(g) require
licensees to submit a ‘‘letter of
notification’’ to the FCC in Washington,
DC, Attention: Audio Division (radio) or
Video Division (television), Media
Bureau, whenever a transmission
system control point is established at a
location other than at the main studio or
transmitter within three days of the
initial use of that point. The letter
should include a list of all control
points in use for clarity. This
notification is not required if
responsible station personnel can be
contacted at the transmitter or studio
site during hours of operation.
Federal Communications Commission.
Katura Jackson,
Federal Register Liaison Officer.
[FR Doc. 2023–09885 Filed 5–9–23; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Intent To Award a Single-Source
Supplement for the Amputee Coalition
of America, Inc. for the National Limb
Loss Resource Center Cooperative
Agreement
ACTION:
Notice.
The Administration for
Community Living (ACL) announces the
intent to award a single-source
supplement to the current cooperative
agreement held by the Amputee
Coalition of America, Inc. for the
National Limb Loss Resource Center
(NLLRC).
SUMMARY:
For
further information or comments
regarding this program supplement,
contact Elizabeth Leef, U.S. Department
of Health and Human Services,
Administration for Community Living,
Administration on Disabilities, Office of
Disability Services Innovation at (202)
475–2486 or Elizabeth.leef@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: The
purpose of this project is to expand on
current grant activities occurring across
lotter on DSK11XQN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
17:49 May 09, 2023
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communities. These activities include
programs that promote independence,
community living, and the adoption of
healthy behaviors that promote wellness
and prevent and/or reduce chronic
conditions associated with limb loss
and increase partnerships and
collaborations with ACL programs that
will benefit all people living with limb
loss or limb differences. The
administrative supplement for FY 2023
will be for $667,048 bringing the total
award for FY 2023 to $4,065,215.
The additional funding will not be
used to begin new projects. The funding
will be used to enhance and expand
existing programs that can serve an
increased number of veterans and
people living with limb loss and limb
differences by providing increased
technical assistance activities;
promoting health and wellness
programs; addressing healthcare access
issues, including maternity care;
promoting the adoption of healthy
behaviors with the objective of
preventing and/or reducing chronic
conditions associated with limb loss;
increasing partnerships and
collaborations with ACL programs that
will benefit all people living with limb
loss or limb differences; enhancing and
expanding the evaluation activities
currently under way; and enhancing
website capacities for improved
information dissemination.
Program Name: National Limb Loss
Resource Center.
Recipient: The Amputee Coalition of
America, Inc.
Period of Performance: The
supplement award will be issued for the
fifth year of the five-year project period
of April 1, 2019, through March 29,
2024.
Total Supplement Award Amount:
$667,048 in FY 2023.
Award Type: Cooperative Agreement
Supplement.
Statutory Authority: This program is
authorized under Section 317 of the
Public Health Service Act (42 U.S.C.
247(b–4)); Consolidated and Further
Continuing Appropriations Act, 2015,
Public Law 113–235 (Dec. 16, 2014).
Basis for Award: The Amputee
Coalition of America, Inc. is currently
funded to carry out the objectives of this
program, entitled The National Limb
Loss Resource Center for the period of
April 1, 2019, through March 29, 2024.
Almost 2 million Americans have
experienced amputations or were born
with limb difference and another 28
million people in our country are at risk
for amputation. The supplement will
enable the grantee to carry their work
even further, serving more people living
with limb loss and/or limb differences
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30131
and providing even more
comprehensive training and technical
assistance in the development of longterm supportive services. The additional
funding will not be used to begin new
projects or activities. The NLLRC will
enhance and expand currently funded
activities such as conducting national
outreach for the development and
dissemination of patient education
materials, programs, and services;
providing technical support and
assistance to community based limb loss
support groups; and raising awareness
about the limb loss and limb differences
communities.
Establishing an entirely new grant
project at this time would be potentially
disruptive to the current work already
well under way. More importantly, the
people living with limb loss and limb
differences currently being served by
this program could be negatively
impacted by a service disruption, thus
posing the risk of not being able to find
the right resources that could negatively
impact on health and wellbeing. If this
supplement were not provided, the
project would be less able to address the
significant unmet needs of additional
limb loss survivors. Similarly, the
project would be unable to expand its
current technical assistance and training
efforts in NLLRC concepts and
approaches, let alone reach beyond
traditional providers of services to this
population to train more ‘‘mainstream’’
providers of disability services.
Dated: May 4, 2023.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2023–09910 Filed 5–9–23; 8:45 am]
BILLING CODE 4154–01–P
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.
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
SUMMARY:
E:\FR\FM\10MYN1.SGM
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30132
Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices
(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, PRAStaff@
fda.hhs.gov.
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/publichealth-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
Current field:
Includes proposed changes to:
Becoming new field:
With accompanying instruction to:
8. Physician
Name, Address,
and Contact Information.
Delete ‘‘Physician’s IND number,
if known’’ from this field and
move to proposed Field 4.a.
Add ‘‘Name of Institution or Clinical Practice’’ to the title of the
field.
Add ‘‘enter the Physician’s IND
Number, if previously issued by
FDA,’’.
1. Physician Name, Name of Institution or Clinical Practice,
Address, and Contact Information.
Remaining fields become renumbered.
4.a. Initial Submission ..................
b Select this box if this form is
an initial submission for an individual patient expanded access
IND, enter the Physician’s IND
Number, if previously issued by
FDA, and complete only fields
5 through 8, and fields 10 and
11.
5. Clinical Information ..................
Brief Clinical History (Patient’s
age, gender, weight, allergies
or sensitivities, race and ethnicity (optional), diagnosis, prior
therapy, response to prior therapy, reason for request, including an explanation of why the
patient lacks other therapeutic
options).
Ethnicity (check one)
b Hispanic/Latino
b Not Hispanic/Latino
Race (check all that apply)
b American Indian/Alaska Native
b Asian
b Black or African American
b Native Hawaiian/Other Pacific
Islander
b White
Enter the physician’s name, name of institution or
clinical practice, and the physician’s contact information, including the physical address, email
address, telephone number, and facsimile (FAX)
number.
lotter on DSK11XQN23PROD with NOTICES1
3.a. Initial Submission.
4. Clinical Information.
Brief Clinical History (Patient’s
age, gender,
weight, allergies,
diagnosis, prior
therapy, response to prior
therapy, reason
for request, including an explanation of why
the patient lacks
other therapeutic options).
VerDate Sep<11>2014
Add ‘‘or sensitivities, race and
ethnicity (optional)’’ after allergies.
Add ‘‘Ethnicity (check one)’’ and
list choice options (Hispanic/
Latino or Not Hispanic/Latino).
Add ‘‘Race (check all that apply)’’
and list choice options (American Indian/Alaska Native or
Asian or Black/African American or Native Hawaiian/Other
Pacific Islander or White).
17:49 May 09, 2023
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Frm 00063
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If the submission is an initial (original) submission
for an individual patient expanded access IND
(including for emergency use), select the box
provided in field 4.a., enter the physician’s IND
number, if previously issued by FDA, and complete only fields 5 through 8, and fields 10 and
11. Do not include commercial sponsor’s IND
number.
Provide the indication (proposed treatment use)
and a brief clinical history of the patient. The
clinical history includes age, gender, weight, allergies or sensitivities (general (e.g., soy) and
drug specific) and other optional demographic
and clinical information (e.g., race (as reported
by the patient; you may choose multiple answers) and ethnicity (choose only one response)), diagnosis (e.g., a brief summary (with
dates) of relevant past medical and surgical history, diagnostic procedures, current stage/severity of disease, and functional status), prior therapy, response to prior therapy (e.g., patient was
treated with drug X and subsequently developed
lung metastasis), and the reason for requesting
the proposed treatment, including an explanation
of why the patient lacks other therapeutic options (e.g., patient has failed or is intolerant to
currently available therapy, or is not eligible for
any clinical trials registered at ClinicalTrials.gov).
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Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices
30133
TABLE 1—SUMMARY OF PROPOSED DATA FIELD CHANGES TO FORM FDA 3926—Continued
Current field:
Includes proposed changes to:
Becoming new field:
With accompanying instruction to:
5: Treatment Information.
Add ‘‘(including rationale for
dose)’’.
Add ‘‘(e.g., assessment criteria/
procedure(s) for monitoring and
frequency)’’.
Add ‘‘(e.g., criteria for adjusting
dose if dose reduction or escalation is planned, criteria for
stopping the treatment),’’.
Add ‘‘(e.g., concomitant medication)’’.
Add ‘‘You may choose to attach
an Investigator Brochure, scientific publication(s), or other
supporting documents, if needed.’’.
Field 6 ..........................................
None ....................
Add a box option for ‘‘Request for
Withdrawal’’ under ‘‘Summary
of Expanded Access Use
(treatment completed)’’.
9. Contents of Submission ...........
None ....................
Add ‘‘When a waiver is requested
in this manner, the physician
does not receive notice from
FDA indicating that the waiver
is granted.’’.
Field 10.b.: Request for Authorization to Use Alternative IRB
Review Procedures.
None ....................
Add ‘‘Information on where and
how to submit this form is available at Expanded Access—
How to Submit’’.
Insert a statement ‘‘Information
on where and how to submit
this form is available at Expanded Access—How to Submit a Request (Forms)’’ under
‘‘Signature of Physician’’ after
Field 11.
Field 11: Certification Statement
and Signature of the Physician.
Provide treatment information, including the investigational drug’s name and the name of the entity supplying the drug (generally the manufacturer), the applicable FDA review division (if
known), and a concise statement regarding the
treatment plan. This includes the planned dose,
route and schedule of administration of the investigational drug (including rationale for dose),
planned duration of treatment, monitoring procedures (e.g., assessment criteria/procedure(s) for
monitoring and frequency), planned modifications to the treatment plan in the event of toxicity
(e.g., criteria for adjusting dose if dose reduction
or escalation is planned, criteria for stopping the
treatment), 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.
Field 9: Contents of Submission (Follow-up/Additional Submissions Only).
Request for Withdrawal: A submission describing
the intent to withdraw an effective IND (21 CFR
312.38).
Select this box to request under 21 CFR 56.105,
authorization to obtain concurrence by the IRB
chairperson or by a designated IRB member, instead of at a convened IRB meeting, before 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.
Field 11: Certification Statement and Signature of
the Physician Information on where and how to
submit this form is available at Expanded Access—How to Submit.
Information on where and how to submit this form
is available at Expanded Access—How to Submit a Request (Forms).
lotter on DSK11XQN23PROD with NOTICES1
[General Instruction?].
b Request for Withdrawal.
[General Instruction?] ...................
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
AGENCY:
[FR Doc. 2023–09982 Filed 5–9–23; 8:45 am]
SUMMARY:
BILLING CODE 4164–01–P
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17:49 May 09, 2023
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Food and Drug Administration
[Docket No. FDA–2022–E–0675]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Detectnet
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for Detectnet and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by July 10, 2023.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
November 6, 2023. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
DATES:
E:\FR\FM\10MYN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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).
[[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.
----------------------------------------------------------------------------------------------------------------
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
