Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; Availability, 34020-34022 [2021-13684]
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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated July 14, 2020, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of Smallpox and Monkeypox
Vaccine, Live represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
khammond on DSKJM1Z7X2PROD with NOTICES
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
Smallpox and Monkeypox Vaccine, Live
is 5,650 days. Of this time, 5,315 days
occurred during the testing phase of the
regulatory review period, while 335
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: April 7, 2004. The
applicant claims March 8, 2004, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was April 7, 2004,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): October 25, 2018. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
Smallpox and Monkeypox Vaccine, Live
(BLA 125678) was initially submitted on
October 25, 2018.
3. The date the application was
approved: September 24, 2019. FDA has
verified the applicant’s claim that BLA
125678 was approved on September 24,
2019.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,825 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
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17:39 Jun 25, 2021
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regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13686 Filed 6–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2099]
Sponsor Responsibilities—Safety
Reporting Requirements and Safety
Assessment for Investigational New
Drug Application and Bioavailability/
Bioequivalence Studies; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Sponsor
Responsibilities—Safety Reporting
Requirements and Safety Assessment for
Investigational New Drug Application
and Bioavailability/Bioequivalence
Studies.’’ The draft guidance provides
recommendations for sponsors and
sponsor-investigators to comply with
the requirements of investigational new
drug application (IND) safety reporting
and safety reporting for bioavailability
(BA) and bioequivalence (BE) studies. In
doing so, the guidance provides
recommendations related to the two IND
safety reporting provisions that require
assessment of aggregate data to facilitate
appropriate IND safety reporting
SUMMARY:
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Fmt 4703
Sfmt 4703
practices. An earlier draft guidance for
industry entitled ‘‘Safety Assessment for
IND Safety Reporting’’ (December 2015)
(the 2015 draft guidance) has been
incorporated into this draft guidance.
However, this content was revised to
address feedback from stakeholders and
comments received on the 2015 draft
guidance. Concurrent with the
publication of this draft guidance, we
are withdrawing the 2015 draft
guidance. Additionally, this draft
guidance incorporates content from the
final guidance for industry and
investigators entitled ‘‘Safety Reporting
Requirements for INDs and BA/BE
Studies’’ (December 2012) (the 2012
final guidance). This incorporated
content remains largely unchanged in
this draft guidance.
DATES: Submit either electronic or
written comments on the draft guidance
by September 27, 2021 to ensure that
the Agency considers your comment on
this draft guidance before it begins work
on the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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.
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices
• 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–
2020–D–2099 for ‘‘Sponsor
Responsibilities—Safety Reporting
Requirements and Safety Assessment for
Investigational New Drug Application
and Bioavailability/Bioequivalence
Studies.’’ Received comments 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-201509-18/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.
VerDate Sep<11>2014
17:39 Jun 25, 2021
Jkt 253001
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. 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: Paul
Gouge, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6328, Silver Spring,
MD 20993–0002, CDEROMP@
fda.hhs.gov; 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:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Sponsor Responsibilities—Safety
Reporting Requirements and Safety
Assessment for Investigational New
Drug Application and Bioavailability/
Bioequivalence Studies.’’ The draft
guidance provides recommendations for
sponsors and sponsor-investigators to
facilitate compliance with the
requirements of IND safety reporting
and safety reporting for BA and BE
studies under §§ 312.32 and
320.31(d)(3) (21 CFR 312.32 and
320.31(d)(3)). In doing so, the draft
guidance provides recommendations for
sponsors related to the two IND safety
reporting provisions (§ 312.32(c)(1)(i)(C)
and (iv)) that require assessment of
aggregate data to facilitate appropriate
IND safety reporting practices. More
generally, it provides sponsors and
sponsor-investigators recommendations
regarding expedited safety reporting
requirements for human drug and
biological products that are being
investigated under an IND and for drugs
that are the subject of BA and BE studies
that are exempt from the IND
requirements.
In the Federal Register of December
17, 2015 (80 FR 78743), FDA announced
the availability of the 2015 draft
guidance entitled ‘‘Safety Assessment
for IND Safety Reporting.’’ FDA received
numerous comments on the 2015 draft
guidance, and these comments were
carefully considered and addressed by
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34021
FDA in this draft guidance. Noteworthy
changes include revised
recommendations on the following: (1)
Planned unblinding of safety data and
implications for trial integrity, (2)
increased flexibility regarding the party
reviewing safety information across a
development program for IND safety
reporting purposes, (3) clarification
regarding the scope and methodology
for aggregate analyses, and (4)
clarification regarding the plan for
safety surveillance, including what
elements should be included in the
plan. Accordingly, concurrent with the
publication of this draft guidance, we
are withdrawing the 2015 draft
guidance.
Further, this draft guidance
incorporates content from the 2012 final
guidance entitled ‘‘Safety Reporting
Requirements for INDs and BA/BE
Studies’’. The content from the 2012
final guidance remains largely
unchanged in this draft guidance;
however, this draft guidance does not
incorporate the investigator provisions
of the 2012 final guidance. FDA intends
to publish a separate draft guidance on
investigator’s responsibilities for safety
reporting for human drug and biological
products that are being investigated
under an IND.
When this draft guidance and the
draft guidance on investigator’s
responsibilities for IND safety reporting
are finalized, FDA plans to withdraw
the 2012 final guidance. However, until
FDA finalizes these two draft guidances,
the 2012 final guidance remains in
effect and represents FDA’s current
thinking.
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 ‘‘Sponsor Responsibilities—Safety
Reporting Requirements and Safety
Assessment for Investigational New
Drug Application and Bioavailability/
Bioequivalence Studies.’’ 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices
OMB under the PRA. The collections of
information in 21 CFR parts 312 and
320 have been approved under OMB
control number 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13684 Filed 6–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–E–0029]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TAZVERIK
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for TAZVERIK 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
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.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 27, 2021.
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
December 27, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:39 Jun 25, 2021
Jkt 253001
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 August 27,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 27, 2021.
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.
ADDRESSES:
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–
2021–E–0029 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; TAZVERIK.’’
Received comments, those filed in a
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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 § 10.20 (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-201509-18/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:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
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]]>Agencies
[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Notices]
[Pages 34020-34022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-2099]
Sponsor Responsibilities--Safety Reporting Requirements and
Safety Assessment for Investigational New Drug Application and
Bioavailability/Bioequivalence Studies; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Sponsor
Responsibilities--Safety Reporting Requirements and Safety Assessment
for Investigational New Drug Application and Bioavailability/
Bioequivalence Studies.'' The draft guidance provides recommendations
for sponsors and sponsor-investigators to comply with the requirements
of investigational new drug application (IND) safety reporting and
safety reporting for bioavailability (BA) and bioequivalence (BE)
studies. In doing so, the guidance provides recommendations related to
the two IND safety reporting provisions that require assessment of
aggregate data to facilitate appropriate IND safety reporting
practices. An earlier draft guidance for industry entitled ``Safety
Assessment for IND Safety Reporting'' (December 2015) (the 2015 draft
guidance) has been incorporated into this draft guidance. However, this
content was revised to address feedback from stakeholders and comments
received on the 2015 draft guidance. Concurrent with the publication of
this draft guidance, we are withdrawing the 2015 draft guidance.
Additionally, this draft guidance incorporates content from the final
guidance for industry and investigators entitled ``Safety Reporting
Requirements for INDs and BA/BE Studies'' (December 2012) (the 2012
final guidance). This incorporated content remains largely unchanged in
this draft guidance.
DATES: Submit either electronic or written comments on the draft
guidance by September 27, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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.
[[Page 34021]]
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-2020-D-2099 for ``Sponsor Responsibilities--Safety Reporting
Requirements and Safety Assessment for Investigational New Drug
Application and Bioavailability/Bioequivalence Studies.'' Received
comments 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.
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. 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: Paul Gouge, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6328, Silver Spring, MD 20993-0002, [email protected];
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:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Sponsor Responsibilities--Safety Reporting Requirements and
Safety Assessment for Investigational New Drug Application and
Bioavailability/Bioequivalence Studies.'' The draft guidance provides
recommendations for sponsors and sponsor-investigators to facilitate
compliance with the requirements of IND safety reporting and safety
reporting for BA and BE studies under Sec. Sec. 312.32 and
320.31(d)(3) (21 CFR 312.32 and 320.31(d)(3)). In doing so, the draft
guidance provides recommendations for sponsors related to the two IND
safety reporting provisions (Sec. 312.32(c)(1)(i)(C) and (iv)) that
require assessment of aggregate data to facilitate appropriate IND
safety reporting practices. More generally, it provides sponsors and
sponsor-investigators recommendations regarding expedited safety
reporting requirements for human drug and biological products that are
being investigated under an IND and for drugs that are the subject of
BA and BE studies that are exempt from the IND requirements.
In the Federal Register of December 17, 2015 (80 FR 78743), FDA
announced the availability of the 2015 draft guidance entitled ``Safety
Assessment for IND Safety Reporting.'' FDA received numerous comments
on the 2015 draft guidance, and these comments were carefully
considered and addressed by FDA in this draft guidance. Noteworthy
changes include revised recommendations on the following: (1) Planned
unblinding of safety data and implications for trial integrity, (2)
increased flexibility regarding the party reviewing safety information
across a development program for IND safety reporting purposes, (3)
clarification regarding the scope and methodology for aggregate
analyses, and (4) clarification regarding the plan for safety
surveillance, including what elements should be included in the plan.
Accordingly, concurrent with the publication of this draft guidance, we
are withdrawing the 2015 draft guidance.
Further, this draft guidance incorporates content from the 2012
final guidance entitled ``Safety Reporting Requirements for INDs and
BA/BE Studies''. The content from the 2012 final guidance remains
largely unchanged in this draft guidance; however, this draft guidance
does not incorporate the investigator provisions of the 2012 final
guidance. FDA intends to publish a separate draft guidance on
investigator's responsibilities for safety reporting for human drug and
biological products that are being investigated under an IND.
When this draft guidance and the draft guidance on investigator's
responsibilities for IND safety reporting are finalized, FDA plans to
withdraw the 2012 final guidance. However, until FDA finalizes these
two draft guidances, the 2012 final guidance remains in effect and
represents FDA's current thinking.
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 ``Sponsor
Responsibilities--Safety Reporting Requirements and Safety Assessment
for Investigational New Drug Application and Bioavailability/
Bioequivalence Studies.'' 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by
[[Page 34022]]
OMB under the PRA. The collections of information in 21 CFR parts 312
and 320 have been approved under OMB control number 0910-0014.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13684 Filed 6-25-21; 8:45 am]
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