Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926, 55723-55726 [2018-24321]
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Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests
for single copies of the draft guidance to
the Division of Drug Information, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Scott N. Goldie, Office of Biostatistics,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, Rm. 3557, Silver Spring,
MD 20993–0002, 301–796–2055; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Meta-Analyses of Randomized
Controlled Clinical Trials to Evaluate
the Safety of Human Drugs or Biological
Products.’’ Evaluating the safety of drug
products, both before approval and after
marketing, is a fundamental
responsibility of the FDA. This
evaluation often requires combining and
integrating information from multiple
sources, and meta-analysis is a useful
tool for this purpose.
This draft guidance describes general
principles of design, conduct, and
reporting that FDA intends to apply to
meta-analyses conducted by the Agency,
and to use as benchmarks when
evaluating meta-analyses conducted by
sponsors or third parties. The focus of
the draft guidance is on the evaluation
of safety. This draft guidance is not
intended to be a reference guide on how
to conduct a meta-analysis. Rather, this
draft guidance document discusses the
important principles underlying best
practices for safety meta-analyses and
the way that FDA intends to factor
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adherence to those principles into its
decision-making process.
This draft guidance is being issued to
fulfill a commitment made under the
Prescription Drug User Fee V agreement
(section IX.B.3 of the document entitled
‘‘PDUFA Reauthorization Performance
Goals and Procedures Fiscal Years 2013
through 2017’’) to promote a better
understanding and increased
consistency among the Agency, industry
and other stakeholders regarding metaanalyses and their role in regulatory
decision-making.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Meta-Analyses of Randomized
Controlled Clinical Trials to Evaluate
the Safety of Human Drugs or Biological
Products.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
parts 312, 314, and 601 have been
approved under OMB control numbers
0910–0014, 0910–0001, and 0910–0338
respectively.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: November 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24316 Filed 11–6–18; 8:45 am]
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55723
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3758]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Individual Patient
Expanded Access Applications: Form
FDA 3926
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 individual patient
expanded access applications.
DATES: Submit either electronic or
written comments on the collection of
information by January 7, 2019.
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 January 7,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 7, 2019. 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.
SUMMARY:
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
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55724
Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
amozie on DSK3GDR082PROD with NOTICES1
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; Guidance
for Industry on Individual Patient
Expanded Access Applications: Form
FDA 3926.’’ 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.
• 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
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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
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)
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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.
Guidance for Industry on Individual
Patient Expanded Access Applications:
Form FDA 3926
OMB Control Number 0910–0814—
Extension
This information collection supports
Agency regulations, associated
guidance, and Form FDA 3926
concerning individual patient expanded
access. Individual patient expanded
access allows an individual patient who
has a serious or immediately lifethreatening disease or condition and
there is no comparable or satisfactory
alternative therapy to diagnose, monitor,
or treat the disease or condition, the use
of an investigational new drug (IND)
outside of a clinical investigation, or the
use of an approved drug where
availability is limited by a risk
evaluation and mitigation strategy.
When applicable criteria in § 312.305(a)
(21 CFR 312.305(a)) (which apply to all
types of expanded access) and the
criteria in § 312.310(a) (21 CFR
312.310(a)) (which apply specifically to
individual patient expanded access,
including for emergency use) are met,
FDA may permit expanded access.
Section 312.305(b) sets forth the
submission requirements for all types of
expanded access requests. To assist
respondents with requirements in
§ 312.305 we developed Form FDA 3926
(Individual Patient Expanded Access
Investigational New Drug Application)
and the guidance document entitled,
‘‘Individual Patient Expanded Access
Applications: Form FDA 3926.’’
The physician may satisfy some of the
submission requirements by referring to
information in an existing IND,
ordinarily the one held by the
investigational drug’s manufacturer, if
the physician obtains permission from
that IND holder. If permission is
obtained, the physician should then
provide to FDA a letter of authorization
(LOA) from the existing IND holder that
permits FDA to reference that IND.
One of the requirements under
§ 312.305(b)(2) is that a ‘‘cover sheet’’
must be included ‘‘meeting the
requirements of § 312.23(a).’’ This
provision applies to several types of
submissions under part 312 (21 CFR
part 312), ranging from commercial
INDs under § 312.23 that involve large
groups of patients enrolled in clinical
trials to requests from physicians to use
an investigational drug for an individual
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Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
patient. Sponsors currently use Form
FDA 1571 for all types of IND
submissions to meet the requirements in
§ 312.23(a).
Concerned that physicians requesting
expanded access for an individual
patient may encounter difficulty in
completing Form FDA 1571 and the
associated documents because the form
is not tailored to requests for individual
patient expanded access, we developed
Form FDA 3926 to comply with the IND
submission requirements in §§ 312.23,
312.305(b), and 312.310(b). Form FDA
3926 provides a streamlined means to
request expanded access and is
available for licensed physicians. FDA
considers a completed Form FDA 3926
with the box in Field 10 checked and
the form signed by the physician to be
a request in accordance with § 312.10
for a waiver of any additional
requirements in part 312 for an IND
submission, including additional
information currently provided in Form
FDA 1571 and Form FDA 1572
(Statement of Investigator, which
provides the identity and qualifications
of the investigator conducting the
clinical investigation).
Under § 312.310(d), in an emergency
situation that requires the patient to be
treated before a written submission can
be made, the request to use the
investigational drug for individual
patient expanded access may be made
by telephone (or other rapid means of
communication) to the appropriate FDA
review division. Authorization of the
emergency use may be given by an FDA
official over the telephone, provided the
physician explains how the expanded
access use will meet the requirements of
§§ 312.305 and 312.310 and agrees to
submit an expanded access application
within 15 working days of FDA’s initial
authorization of the expanded access
use (§ 312.310(d)). The physician may
choose to use Form FDA 3926 for the
expanded access application.
As explained in the instructions for
Form FDA 3926 and discussed in the
guidance document, the following
information is submitted to FDA:
• Initials for the patient and date of
submission.
• Type of submission (initial or
follow-up submission).
• Clinical information, including
indication, brief clinical history of the
patient (age, gender, weight, allergies,
diagnosis, prior therapy, response to
prior therapy), and the reason for
requesting the proposed treatment,
including an explanation of why the
patient lacks other therapeutic options.
• 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 the treatment plan. This
should include the planned dose, route
and schedule of administration, planned
duration of treatment, monitoring
procedures, and planned modifications
to the treatment plan in the event of
toxicity.
• LOA, generally obtained from the
entity that is the sponsor of the IND
(e.g., commercial sponsor/drug
manufacturer) being referenced, if
applicable.
• Physician’s qualification statement.
An appropriate statement includes
medical school attended, year of
graduation, medical specialty, State
medical license number, current
employment, and job title.
Alternatively, the relevant portion of the
physician’s curriculum vitae may be
attached.
• Physician’s contact information,
including name, physical address, email
address, telephone number, facsimile
number, and physician’s IND number, if
previously issued by FDA.
• Contents of submission (for followup/additional submissions), including
the type of submission being made. FDA
55725
accepts Form FDA 3926 for certain
follow-up/additional submissions,
which include the following: Initial
Written IND Safety Report (§ 312.32(c));
Followup to a Written IND Safety
Report (§ 312.32(d)); Annual Report
(§ 312.33); Summary of Expanded
Access Use (treatment completed)
(§ 312.310(c)(2)); Change in Treatment
Plan (§ 312.30); General Correspondence
or Response to FDA Request for
Information (§ 312.41); and Response to
Clinical Hold (§ 312.42(e)).
• Request for authorization to use
Form FDA 3926 for individual patient
expanded access application.
• Signature of the physician
certifying that treatment will not begin
until 30 days after FDA receives the
completed application and all required
material unless the submitting
physician receives earlier notification
from FDA that the treatment may
proceed. The physician agrees not to
begin or continue clinical investigations
covered by the IND if those studies are
placed on clinical hold. The physician
also certifies that informed consent will
be obtained in compliance with Federal
requirements (including FDA’s
regulations in 21 CFR part 50) and that
an institutional review board (IRB) that
complies with all Federal requirements
(including FDA’s regulations in 21 CFR
part 56) will be responsible for initial
and continuing review and approval of
the expanded access use. The physician
also acknowledges that in the case of an
emergency request, treatment may begin
without prior IRB approval, provided
the IRB is notified of the emergency
treatment within 5 working days of
treatment. The physician agrees to
conduct the investigation in accordance
with all other applicable regulatory
requirements.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance on Individual Patient
Expanded Access
Applications: Form FDA 3926
Number of
respondents
Expanded access submission elements included in
Form FDA 3926.
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1 There
Number of
responses per
respondent
790
Average
burden per
response
Total annual
responses
3.03
2,394
0.75 (45 mins.) ......
Total hours
1,795
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we are retaining the
currently approved burden estimate.
The estimates for ‘‘number of
respondents,’’ ‘‘number of responses per
respondent,’’ and ‘‘total annual
responses’’ were obtained from reports
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and data management systems from the
Center for Drug Evaluation and Research
(CDER) and from other sources familiar
with the number of submissions
received for individual patient
expanded access use under part 312.
The estimates for ‘‘average burden per
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response’’ were based on information
CDER provided and personnel of the
U.S. Department of Health and Human
Services familiar with preparing and
reviewing expanded access submissions
by practicing physicians.
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Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
Based on data from the Document
Archiving, Reporting and Regulatory
Tracking System for the number of
submissions to FDA using FDA Form
3926 during fiscal years 2015, 2016, and
2017, we estimate that approximately
790 licensed physicians would use FDA
Form 3926 to submit 1.46 requests per
physician (respondent) for individual
patient expanded access, for a total of
1,153 responses annually. Based on
these estimates, FDA calculates the total
annual responses to be 2,394 (1,153
requests for individual patient
expanded access and 1,241 follow-up
submissions) by 790 physicians for an
average of 3.03 responses per
respondent. FDA estimates the average
burden per response to be 45 minutes
(0.75 hour). Based on this estimate, FDA
calculates the total burden to be 1,795
hours.
Dated: October 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24321 Filed 11–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4130]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recordkeeping
Requirements for Microbiological
Testing and Corrective Measures for
Bottled Water
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 the procedure by
which both domestic and foreign bottled
water manufacturers that sell bottled
water in the United States maintain
records of microbiological testing and
corrective measures, in addition to
existing recordkeeping requirements.
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
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17:46 Nov 06, 2018
Jkt 247001
Submit either electronic or
written comments on the collection of
information by January 7, 2019.
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 January 7,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 7, 2019. 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.
DATES:
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–4130 for ‘‘Agency Information
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Fmt 4703
Sfmt 4703
Collection Activities; Proposed
Collection; Comment Request;
Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water.’’ 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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]]>Agencies
[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55723-55726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24321]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3758]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Individual Patient Expanded Access Applications: Form
FDA 3926
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 individual patient expanded
access applications.
DATES: Submit either electronic or written comments on the collection
of information by January 7, 2019.
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 January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 7, 2019. 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
[[Page 55724]]
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; Guidance for Industry on
Individual Patient Expanded Access Applications: Form FDA 3926.''
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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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.
Guidance for Industry on Individual Patient Expanded Access
Applications: Form FDA 3926
OMB Control Number 0910-0814--Extension
This information collection supports Agency regulations, associated
guidance, and Form FDA 3926 concerning individual patient expanded
access. Individual patient expanded access allows an individual patient
who has a serious or immediately life-threatening disease or condition
and there is no comparable or satisfactory alternative therapy to
diagnose, monitor, or treat the disease or condition, the use of an
investigational new drug (IND) outside of a clinical investigation, or
the use of an approved drug where availability is limited by a risk
evaluation and mitigation strategy. When applicable criteria in Sec.
312.305(a) (21 CFR 312.305(a)) (which apply to all types of expanded
access) and the criteria in Sec. 312.310(a) (21 CFR 312.310(a)) (which
apply specifically to individual patient expanded access, including for
emergency use) are met, FDA may permit expanded access.
Section 312.305(b) sets forth the submission requirements for all
types of expanded access requests. To assist respondents with
requirements in Sec. 312.305 we developed Form FDA 3926 (Individual
Patient Expanded Access Investigational New Drug Application) and the
guidance document entitled, ``Individual Patient Expanded Access
Applications: Form FDA 3926.''
The physician may satisfy some of the submission requirements by
referring to information in an existing IND, ordinarily the one held by
the investigational drug's manufacturer, if the physician obtains
permission from that IND holder. If permission is obtained, the
physician should then provide to FDA a letter of authorization (LOA)
from the existing IND holder that permits FDA to reference that IND.
One of the requirements under Sec. 312.305(b)(2) is that a ``cover
sheet'' must be included ``meeting the requirements of Sec.
312.23(a).'' This provision applies to several types of submissions
under part 312 (21 CFR part 312), ranging from commercial INDs under
Sec. 312.23 that involve large groups of patients enrolled in clinical
trials to requests from physicians to use an investigational drug for
an individual
[[Page 55725]]
patient. Sponsors currently use Form FDA 1571 for all types of IND
submissions to meet the requirements in Sec. 312.23(a).
Concerned that physicians requesting expanded access for an
individual patient may encounter difficulty in completing Form FDA 1571
and the associated documents because the form is not tailored to
requests for individual patient expanded access, we developed Form FDA
3926 to comply with the IND submission requirements in Sec. Sec.
312.23, 312.305(b), and 312.310(b). Form FDA 3926 provides a
streamlined means to request expanded access and is available for
licensed physicians. FDA considers a completed Form FDA 3926 with the
box in Field 10 checked and the form signed by the physician to be a
request in accordance with Sec. 312.10 for a waiver of any additional
requirements in part 312 for an IND submission, including additional
information currently provided in Form FDA 1571 and Form FDA 1572
(Statement of Investigator, which provides the identity and
qualifications of the investigator conducting the clinical
investigation).
Under Sec. 312.310(d), in an emergency situation that requires the
patient to be treated before a written submission can be made, the
request to use the investigational drug for individual patient expanded
access may be made by telephone (or other rapid means of communication)
to the appropriate FDA review division. Authorization of the emergency
use may be given by an FDA official over the telephone, provided the
physician explains how the expanded access use will meet the
requirements of Sec. Sec. 312.305 and 312.310 and agrees to submit an
expanded access application within 15 working days of FDA's initial
authorization of the expanded access use (Sec. 312.310(d)). The
physician may choose to use Form FDA 3926 for the expanded access
application.
As explained in the instructions for Form FDA 3926 and discussed in
the guidance document, the following information is submitted to FDA:
Initials for the patient and date of submission.
Type of submission (initial or follow-up submission).
Clinical information, including indication, brief clinical
history of the patient (age, gender, weight, allergies, diagnosis,
prior therapy, response to prior therapy), and the reason for
requesting the proposed treatment, including an explanation of why the
patient lacks other therapeutic options.
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
the treatment plan. This should include the planned dose, route and
schedule of administration, planned duration of treatment, monitoring
procedures, and planned modifications to the treatment plan in the
event of toxicity.
LOA, generally obtained from the entity that is the
sponsor of the IND (e.g., commercial sponsor/drug manufacturer) being
referenced, if applicable.
Physician's qualification statement. An appropriate
statement includes medical school attended, year of graduation, medical
specialty, State medical license number, current employment, and job
title. Alternatively, the relevant portion of the physician's
curriculum vitae may be attached.
Physician's contact information, including name, physical
address, email address, telephone number, facsimile number, and
physician's IND number, if previously issued by FDA.
Contents of submission (for follow-up/additional
submissions), including the type of submission being made. FDA accepts
Form FDA 3926 for certain follow-up/additional submissions, which
include the following: Initial Written IND Safety Report (Sec.
312.32(c)); Followup to a Written IND Safety Report (Sec. 312.32(d));
Annual Report (Sec. 312.33); Summary of Expanded Access Use (treatment
completed) (Sec. 312.310(c)(2)); Change in Treatment Plan (Sec.
312.30); General Correspondence or Response to FDA Request for
Information (Sec. 312.41); and Response to Clinical Hold (Sec.
312.42(e)).
Request for authorization to use Form FDA 3926 for
individual patient expanded access application.
Signature of the physician certifying that treatment will
not begin until 30 days after FDA receives the completed application
and all required material unless the submitting physician receives
earlier notification from FDA that the treatment may proceed. The
physician agrees not to begin or continue clinical investigations
covered by the IND if those studies are placed on clinical hold. The
physician also certifies that informed consent will be obtained in
compliance with Federal requirements (including FDA's regulations in 21
CFR part 50) and that an institutional review board (IRB) that complies
with all Federal requirements (including FDA's regulations in 21 CFR
part 56) will be responsible for initial and continuing review and
approval of the expanded access use. The physician also acknowledges
that in the case of an emergency request, treatment may begin without
prior IRB approval, provided the IRB is notified of the emergency
treatment within 5 working days of treatment. The physician agrees to
conduct the investigation in accordance with all other applicable
regulatory requirements.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Guidance on Individual Patient Expanded Number of responses per Total annual Average burden per response Total hours
Access Applications: Form FDA 3926 respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expanded access submission elements included 790 3.03 2,394 0.75 (45 mins.).......................... 1,795
in Form FDA 3926.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection, we are retaining
the currently approved burden estimate. The estimates for ``number of
respondents,'' ``number of responses per respondent,'' and ``total
annual responses'' were obtained from reports and data management
systems from the Center for Drug Evaluation and Research (CDER) and
from other sources familiar with the number of submissions received for
individual patient expanded access use under part 312. The estimates
for ``average burden per response'' were based on information CDER
provided and personnel of the U.S. Department of Health and Human
Services familiar with preparing and reviewing expanded access
submissions by practicing physicians.
[[Page 55726]]
Based on data from the Document Archiving, Reporting and Regulatory
Tracking System for the number of submissions to FDA using FDA Form
3926 during fiscal years 2015, 2016, and 2017, we estimate that
approximately 790 licensed physicians would use FDA Form 3926 to submit
1.46 requests per physician (respondent) for individual patient
expanded access, for a total of 1,153 responses annually. Based on
these estimates, FDA calculates the total annual responses to be 2,394
(1,153 requests for individual patient expanded access and 1,241
follow-up submissions) by 790 physicians for an average of 3.03
responses per respondent. FDA estimates the average burden per response
to be 45 minutes (0.75 hour). Based on this estimate, FDA calculates
the total burden to be 1,795 hours.
Dated: October 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24321 Filed 11-6-18; 8:45 am]
BILLING CODE 4164-01-P
