Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control; Draft Guidance for Industry; Availability, 13903-13905 [2020-04877]
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Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices
Alternatively, copies can also be
obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: ACF is proposing data
collection as part of the study, ‘‘Survey
of Youth Transitioning from Foster
Care.’’ This Notice provides the
trafficking and other victimization
histories, internal and external assets,
and risk and protective factors.
Involvement with child welfare and
juvenile justice systems, and utilization
of other services will also be addressed
in the data collection.
Respondents: Youth aged 18 or 19
who were in foster care during their
17th year.
Annual Burden Estimates
Data collection is expected to take
place over 2 years.
Instrument
Total
number of
respondents
Annual
number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Annual burden
hours
Survey of Youth Transitioning from Foster Care .................
780
390
1
1.2
468
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
with type 2 diabetes. Publication of this
guidance is intended to provide clarity
on the expectations for the development
of drugs and biologics to improve
glycemic control and to serve as a focus
for commentary and feedback.
DATES: Submit either electronic or
written comments on the draft guidance
by June 8, 2020 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draft guidance before it begins work on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:
Food and Drug Administration
Electronic Submissions
[Docket No. FDA–2019–N–6084]
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’’).
Estimated Total Annual Burden
Hours: 468.
Authority: Section 476(a)(1–2) (42 U.S.C.
676) of the Social Security Act Part E—
Federal Payments for Foster Care and
Adoption Assistance.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–04805 Filed 3–9–20; 8:45 am]
BILLING CODE 4184–25–P
Type 2 Diabetes Mellitus: Evaluating
the Safety of New Drugs for Improving
Glycemic Control; 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 ‘‘Type 2
Diabetes Mellitus: Evaluating the Safety
of New Drugs for Improving Glycemic
Control.’’ This draft guidance replaces
the guidance for industry entitled
‘‘Diabetes Mellitus—Evaluating
Cardiovascular Risk in New
Antidiabetic Therapies to Treat Type 2
Diabetes’’ and the draft guidance for
industry ‘‘Diabetes Mellitus: Developing
Drugs and Therapeutic Biologics for
Treatment and Prevention,’’ both of
which are being withdrawn. This draft
guidance outlines the Agency’s current
recommendations on the evaluation of
safety for new drugs and biologics to
improve glycemic control in patients
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
opportunity to comment on a survey of
youth with current or recent
involvement in foster care.
Primary data collected includes a onetime survey with up to 780 youth aged
18 or 19 who were in foster care during
their 17th year. The survey will be
conducted in-person, with both field
interviewer-administered items and
Audio-Computer Assisted SelfInterview (ACASI) items that the youth
will complete privately for sensitive
topics. Survey questions will be focused
on the youths’ demographic data,
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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–
2019–N–6084 for ‘‘Type 2 Diabetes
Mellitus: Evaluating the Safety of New
Drugs for Improving Glycemic Control.’’
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.
• 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
E:\FR\FM\10MRN1.SGM
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13904
Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices
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.
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:
Silvana Borges, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3200,
Silver Spring, MD 20993–0002, 301–
796–0963.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Type 2 Diabetes Mellitus: Evaluating
the Safety of New Drugs for Improving
Glycemic Control.’’ This draft guidance
replaces the guidance for industry
entitled ‘‘Diabetes Mellitus—Evaluating
Cardiovascular Risk in New
Antidiabetic Therapies to Treat Type 2
Diabetes,’’ published in December 2008,
and the draft guidance for industry
‘‘Diabetes Mellitus: Developing Drugs
and Therapeutic Biologics for Treatment
and Prevention,’’ published in February
VerDate Sep<11>2014
17:20 Mar 09, 2020
Jkt 250001
2008, both of which are being
withdrawn.
In response to questions and concerns
about increased cardiovascular risk with
certain antidiabetic therapies, FDA
convened an advisory committee
meeting in July 2008 to discuss the role
of cardiovascular risk assessments for
the safety evaluation of drugs and
biologics developed for the treatment of
type 2 diabetes. Based, in part, on
comments expressed at that meeting, the
Agency issued a guidance for industry
in December 2008 outlining
recommendations on the evaluation of
cardiovascular risk for new antidiabetic
therapies. That guidance stated that
developers should demonstrate that new
antidiabetic drugs and biologics would
not result in an unacceptable increase in
cardiovascular risk.
Since that time, FDA has reviewed the
results of several cardiovascular
outcome trials (CVOTs) conducted to
meet the December 2008 guidance
recommendations. None of the CVOTs
to date have identified an increased risk
of ischemic cardiovascular events; some
of the CVOTs have instead
demonstrated a reduced risk for
cardiovascular events. In light of the
CVOT results, FDA is revisiting the
recommendations of the December 2008
guidance and is now proposing an
updated approach to evaluating the
safety of new drugs and biologics to
improve glycemic control. In addition,
FDA is withdrawing the February 2008
guidance because its recommendations
for safety assessment have become
outdated.
FDA is establishing this docket to
solicit input from stakeholders on all
aspects of these issues, including
comments on specific questions posed
in section II, Additional Issues for
Consideration.
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 ‘‘Type 2 Diabetes Mellitus:
Evaluating the Safety of New Drugs for
Improving Glycemic Control.’’ 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. Additional Issues for Consideration
FDA is soliciting comments from
stakeholders regarding the issues
described in this notice and the draft
guidance. In addition to any other
aspects of the guidance that
stakeholders may care to comment
upon, FDA is interested in answers to
PO 00000
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the following questions/topics in
particular:
A. Size of Population and Exposure to
the Investigational Drug/Biologic
1. Is it more important to emphasize
the number of patients exposed or the
amount of exposure (i.e., number of
patient-years)? Or should there be
expectations set for both parameters?
2. What would constitute a minimally
acceptable database (either in number of
patients, number of patient-years, or
both) in terms of exposure to
investigational drug/biologic at time of
filing of the marketing application?
B. Demographic Characteristics of the
Population
1. What are the important comorbid
conditions to include?
2. What would be a minimally
acceptable number of patients or
number of patient-years to include for
each important comorbid condition?
C. Necessary Safety Evaluations
1. Are there specific safety concerns
for patients with type 2 diabetes that
should be rigorously evaluated?
2. If there are specific safety concerns
that should be rigorously evaluated,
how should that assessment be
conducted?
3. Is the adjudication of adverse
events related to a specific safety
concern a necessary part of the safety
assessment? If so, should it be
conducted by an independent, blinded
adjudication committee or would other
means of adjudication be adequate?
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved FDA collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collection of information in 21 CFR part
312 has been approved under OMB
control number 0910–0014; the
collection of information in 21 CFR part
314 has been approved under OMB
control number 0910–0001; and the
collection of information for clinical
trial data monitoring committees has
been approved under OMB control
number 0910–0581.
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
E:\FR\FM\10MRN1.SGM
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Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices
Dated: March 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04877 Filed 3–9–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Advisory Committee; Gastrointestinal
Drugs Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Gastrointestinal Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Gastrointestinal
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until March 3, 2022.
DATES: Authority for the Gastrointestinal
Drugs Advisory Committee will expire
on March 3, 2022, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Jay
Fajiculay, Division of Advisory
Committee and Consultant
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
GIDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3, FDA is announcing
the renewal of the Gastrointestinal
Drugs Advisory Committee (the
Committee). The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of gastrointestinal
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SUMMARY:
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17:20 Mar 09, 2020
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diseases and makes appropriate
recommendations to the Commissioner.
Pursuant to its Charter, the Committee
shall consist of a core of 11 voting
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of gastroenterology, endocrinology,
surgery, clinical pharmacology,
physiology, pathology, liver function,
motility, esophagitis, and statistics.
Members will be invited to serve for
overlapping terms of up to 4 years.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
gastrointestinal-drugs-advisorycommittee or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: March 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04778 Filed 3–9–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6644]
Fiscal Year 2020 Generic Drug
Regulatory Science Initiatives; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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13905
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘FY 2020 Generic
Drug Regulatory Science Initiatives.’’
The purpose of the public workshop is
to provide an overview of the status of
regulatory science initiatives for generic
drugs and an opportunity for public
input on these initiatives. FDA is
seeking this input from a variety of
stakeholders—industry, academia,
patient advocates, professional societies,
and other interested parties—as it
fulfills its commitment under the
Generic Drug User Fee Amendments of
2017 (GDUFA II) to develop an annual
list of regulatory science initiatives
specific to generic drugs. FDA will take
the information it obtains from the
public workshop into account in
developing its fiscal year (FY) 2021
regulatory science initiatives.
DATES: The public workshop will be
held on May 4, 2020, from 8:30 a.m. to
4:30 p.m. Submit either electronic or
written comments on this public
workshop by June 4, 2020. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (Rm.
1503, sections B and C), Silver Spring,
MD 20993–0002. Entrance for the public
workshop participants (non-FDA
employees) is through Bldg. 1, where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/Workingat
FDA/BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
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 June 4, 2020. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
June 4, 2020. 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,
E:\FR\FM\10MRN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Pages 13903-13905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04877]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-6084]
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for
Improving Glycemic Control; 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 ``Type 2
Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving
Glycemic Control.'' This draft guidance replaces the guidance for
industry entitled ``Diabetes Mellitus--Evaluating Cardiovascular Risk
in New Antidiabetic Therapies to Treat Type 2 Diabetes'' and the draft
guidance for industry ``Diabetes Mellitus: Developing Drugs and
Therapeutic Biologics for Treatment and Prevention,'' both of which are
being withdrawn. This draft guidance outlines the Agency's current
recommendations on the evaluation of safety for new drugs and biologics
to improve glycemic control in patients with type 2 diabetes.
Publication of this guidance is intended to provide clarity on the
expectations for the development of drugs and biologics to improve
glycemic control and to serve as a focus for commentary and feedback.
DATES: Submit either electronic or written comments on the draft
guidance by June 8, 2020 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.
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-2019-N-6084 for ``Type 2 Diabetes Mellitus: Evaluating the Safety
of New Drugs for Improving Glycemic Control.'' 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.
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
[[Page 13904]]
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.
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: Silvana Borges, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3200, Silver Spring, MD 20993-0002, 301-
796-0963.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs
for Improving Glycemic Control.'' This draft guidance replaces the
guidance for industry entitled ``Diabetes Mellitus--Evaluating
Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2
Diabetes,'' published in December 2008, and the draft guidance for
industry ``Diabetes Mellitus: Developing Drugs and Therapeutic
Biologics for Treatment and Prevention,'' published in February 2008,
both of which are being withdrawn.
In response to questions and concerns about increased
cardiovascular risk with certain antidiabetic therapies, FDA convened
an advisory committee meeting in July 2008 to discuss the role of
cardiovascular risk assessments for the safety evaluation of drugs and
biologics developed for the treatment of type 2 diabetes. Based, in
part, on comments expressed at that meeting, the Agency issued a
guidance for industry in December 2008 outlining recommendations on the
evaluation of cardiovascular risk for new antidiabetic therapies. That
guidance stated that developers should demonstrate that new
antidiabetic drugs and biologics would not result in an unacceptable
increase in cardiovascular risk.
Since that time, FDA has reviewed the results of several
cardiovascular outcome trials (CVOTs) conducted to meet the December
2008 guidance recommendations. None of the CVOTs to date have
identified an increased risk of ischemic cardiovascular events; some of
the CVOTs have instead demonstrated a reduced risk for cardiovascular
events. In light of the CVOT results, FDA is revisiting the
recommendations of the December 2008 guidance and is now proposing an
updated approach to evaluating the safety of new drugs and biologics to
improve glycemic control. In addition, FDA is withdrawing the February
2008 guidance because its recommendations for safety assessment have
become outdated.
FDA is establishing this docket to solicit input from stakeholders
on all aspects of these issues, including comments on specific
questions posed in section II, Additional Issues for Consideration.
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 ``Type 2
Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving
Glycemic Control.'' 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. Additional Issues for Consideration
FDA is soliciting comments from stakeholders regarding the issues
described in this notice and the draft guidance. In addition to any
other aspects of the guidance that stakeholders may care to comment
upon, FDA is interested in answers to the following questions/topics in
particular:
A. Size of Population and Exposure to the Investigational Drug/Biologic
1. Is it more important to emphasize the number of patients exposed
or the amount of exposure (i.e., number of patient-years)? Or should
there be expectations set for both parameters?
2. What would constitute a minimally acceptable database (either in
number of patients, number of patient-years, or both) in terms of
exposure to investigational drug/biologic at time of filing of the
marketing application?
B. Demographic Characteristics of the Population
1. What are the important comorbid conditions to include?
2. What would be a minimally acceptable number of patients or
number of patient-years to include for each important comorbid
condition?
C. Necessary Safety Evaluations
1. Are there specific safety concerns for patients with type 2
diabetes that should be rigorously evaluated?
2. If there are specific safety concerns that should be rigorously
evaluated, how should that assessment be conducted?
3. Is the adjudication of adverse events related to a specific
safety concern a necessary part of the safety assessment? If so, should
it be conducted by an independent, blinded adjudication committee or
would other means of adjudication be adequate?
III. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved FDA collections
of information. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521). The collection of
information in 21 CFR part 312 has been approved under OMB control
number 0910-0014; the collection of information in 21 CFR part 314 has
been approved under OMB control number 0910-0001; and the collection of
information for clinical trial data monitoring committees has been
approved under OMB control number 0910-0581.
IV. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
[[Page 13905]]
Dated: March 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04877 Filed 3-9-20; 8:45 am]
BILLING CODE 4164-01-P
