Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Guidance for Industry; Availability, 4668-4670 [2020-01312]
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Federal Register / Vol. 85, No. 17 / Monday, January 27, 2020 / Notices
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Copies of the proposed collection may
be obtained by emailing infocollection@
acf.hhs.gov. 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: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The Trafficking Victims
Protection Act of 2000, as amended,
authorizes the Secretary of Health and
Human Services to establish a program
to assist United States citizens and
lawful permanent residents who are
victims of severe forms of trafficking (22
U.S.C. 7105(f)). OTIP will award
cooperative agreements to implement
the DVHT program, which will include:
(1) The Domestic Victims of Human
Trafficking and Services Outreach
Program, (2) Demonstration Grants to
Strengthen the Response to Victims of
Human Trafficking in Native
Communities Program, and (3) the
Strengthen the Health Care Response for
Victims of Human Trafficking Program.
Through the DVHT program, grantees
will provide comprehensive case
management to domestic survivors of
severe forms of human trafficking in a
traditional case management, Native
community, or health care setting. The
intent of the program is to connect
survivors with the services they need to
improve their lives and health
outcomes.
OTIP proposes to collect information
to measure grant project performance,
provide technical assistance to grantees,
assess program outcomes, improve
program evaluation, respond to
congressional inquiries and mandated
reports, and inform policy and program
development that is responsive to the
needs of victims.
The information collection captures
information on participant
demographics (e.g., age, sex, and
country of origin); types of trafficking
experienced (e.g., sex, labor, or both);
types of enrollment; types of services
requested and provided, along with
their cost; barriers to service delivery;
subrecipients enrolled into the grantee’s
network; victim outreach activities; and
the types of training provided to
subrecipient organizations or other
partners.
Respondents: Domestic Victims of
Human Trafficking and Services
Outreach Program grantees,
Demonstration Grants to Strengthen the
Response to Victims of Human
Trafficking in Native Communities
Program grantees, and the Strengthen
the Health Care Response for Victims of
Human Trafficking Program grantees.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Client Characteristics and Enrollment Form ........................
Client Service Use and Delivery Form ................................
Client Case Closure Form ...................................................
Barriers to Service Delivery and Monitoring Form ..............
DVHT Spending Form .........................................................
Partnership Development and Expansion: Enrollment
Form .................................................................................
Partnership Development and Expansion: Exit Form .........
Training Form .......................................................................
Victim Outreach Reporting Form .........................................
Estimated Total Annual Burden
Hours: 1,424.
Authority: 22 U.S.C. 7105(f).
BILLING CODE 4184–47–P
1,908
1,431
319
90
81
636
477
106
30
27
25
25
36
36
1
1
15
15
.25
.083
.5
.3
6
2
270
162
3
1
90
54
Hematologic Malignancies: Regulatory
Considerations for Use of Minimal
Residual Disease in Development of
Drug and Biological Products for
Treatment; Guidance for Industry;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Hematologic Malignancies: Regulatory
SUMMARY:
VerDate Sep<11>2014
16:54 Jan 24, 2020
Jkt 250001
PO 00000
Frm 00047
Annual
burden hours
1
.25
.167
.167
.75
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Total
burden hours
1
3
1
15
3
[Docket No. FDA–2018–D–3090]
[FR Doc. 2020–01265 Filed 1–24–20; 8:45 am]
Average
burden hours
per response
1,908
1,908
1,908
36
36
Food and Drug Administration
Mary B. Jones,
ACF/OPRE Certifying Officer.
khammond on DSKJM1Z7X2PROD with NOTICES
Total
number of
responses per
respondent
Fmt 4703
Sfmt 4703
Considerations for Use of Minimal
Residual Disease in Development of
Drug and Biological Products for
Treatment.’’ This guidance is intended
to help sponsors planning to use
minimal residual disease (MRD) as a
biomarker in clinical trials conducted
under an investigational new drug
application (IND) or to support
marketing approval of drugs and
biological products for treating specific
hematologic malignancies. An analysis
of marketing applications showed
inconsistent quality of MRD data. Based
on this analysis and discussion at
various public workshops on MRD, FDA
identified a need to provide guidance on
the use of MRD as a biomarker in
regulatory submissions. This guidance
finalizes the draft guidance of the same
title issued on October 16, 2018.
E:\FR\FM\27JAN1.SGM
27JAN1
Federal Register / Vol. 85, No. 17 / Monday, January 27, 2020 / Notices
The announcement of the
guidance is published in the Federal
Register on January 27, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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–D–3090 for ‘‘Hematologic
Malignancies: Regulatory
Considerations for Use of Minimal
Residual Disease in Development of
Drug and Biological Products for
Treatment.’’ 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
VerDate Sep<11>2014
16:54 Jan 24, 2020
Jkt 250001
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.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 this 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 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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
4669
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Nicole Gormley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2310,
Silver Spring, MD 20993–0002, 240–
402–0210; 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 final guidance for industry entitled
‘‘Hematologic Malignancies: Regulatory
Considerations for Use of Minimal
Residual Disease in Development of
Drug and Biological Products for
Treatment.’’ This guidance is intended
to help sponsors planning to use MRD
as a biomarker in clinical trials
conducted under an IND or to support
marketing approval of drugs and
biological products for treating specific
hematologic malignancies.
This guidance finalizes the draft
guidance of the same title issued on
October 16, 2018 (83 FR 52225). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include editorial changes
and clarifications throughout the
document and the addition of
definitions for individual-level and
trial-level associations.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the current
thinking of FDA on ‘‘Hematologic
Malignancies: Regulatory
Considerations for Use of Minimal
Residual Disease in Development of
Drug and Biological Products for
Treatment.’’ 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
This guidance refers to previously
approved collections of information
found in FDA regulations. 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–
3520). The collection of information in
21 CFR part 312 for submitting INDs has
been approved under OMB control
E:\FR\FM\27JAN1.SGM
27JAN1
4670
Federal Register / Vol. 85, No. 17 / Monday, January 27, 2020 / Notices
number 0910–0014. The collection of
information in 21 CFR part 314 for the
submission of new drug applications
has been approved under OMB control
number 0910–0001. The submission of
special protocol assessments has been
approved under OMB control number
0910–0470. The submission of biologics
license applications has been approved
under OMB control number 0910–0338.
The submission of investigational
device exemptions has been approved
under OMB control number 0910–0078.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: January 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01312 Filed 1–24–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4964]
Demonstrating Substantial Evidence of
Effectiveness for Human Drug and
Biological Products; Draft Guidance
for Industry; Availability; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice entitled ‘‘Demonstrating
Substantial Evidence of Effectiveness for
Human Drug and Biological Products;
Draft Guidance for Industry;
Availability’’ that appeared in the
Federal Register of December 20, 2019.
The Agency is taking this action in
response to requests for an extension to
allow interested persons additional time
to submit comments.
DATES: FDA is extending the comment
period for the notice published on
December 20, 2019 (84 FR 70196).
Submit either electronic or written
comments on the draft guidance by
March 19, 2020, to ensure that the
Agency considers your comment on this
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:54 Jan 24, 2020
Jkt 250001
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit either
electronic or written comments 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–D–4964 for ‘‘Demonstrating
Substantial Evidence of Effectiveness for
Human Drug and Biological Products.’’
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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.’’ We
will review this copy, including the
claimed confidential information, in our
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.
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 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 or
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:
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
E:\FR\FM\27JAN1.SGM
27JAN1
]]>Agencies
[Federal Register Volume 85, Number 17 (Monday, January 27, 2020)]
[Notices]
[Pages 4668-4670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3090]
Hematologic Malignancies: Regulatory Considerations for Use of
Minimal Residual Disease in Development of Drug and Biological Products
for Treatment; 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 final guidance for industry entitled
``Hematologic Malignancies: Regulatory Considerations for Use of
Minimal Residual Disease in Development of Drug and Biological Products
for Treatment.'' This guidance is intended to help sponsors planning to
use minimal residual disease (MRD) as a biomarker in clinical trials
conducted under an investigational new drug application (IND) or to
support marketing approval of drugs and biological products for
treating specific hematologic malignancies. An analysis of marketing
applications showed inconsistent quality of MRD data. Based on this
analysis and discussion at various public workshops on MRD, FDA
identified a need to provide guidance on the use of MRD as a biomarker
in regulatory submissions. This guidance finalizes the draft guidance
of the same title issued on October 16, 2018.
[[Page 4669]]
DATES: The announcement of the guidance is published in the Federal
Register on January 27, 2020.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2018-D-3090 for ``Hematologic Malignancies: Regulatory
Considerations for Use of Minimal Residual Disease in Development of
Drug and Biological Products for Treatment.'' 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 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 this 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 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: Nicole Gormley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2310, Silver Spring, MD 20993-0002, 240-
402-0210; 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 final guidance for industry
entitled ``Hematologic Malignancies: Regulatory Considerations for Use
of Minimal Residual Disease in Development of Drug and Biological
Products for Treatment.'' This guidance is intended to help sponsors
planning to use MRD as a biomarker in clinical trials conducted under
an IND or to support marketing approval of drugs and biological
products for treating specific hematologic malignancies.
This guidance finalizes the draft guidance of the same title issued
on October 16, 2018 (83 FR 52225). FDA considered comments received on
the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include editorial changes and
clarifications throughout the document and the addition of definitions
for individual-level and trial-level associations.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on ``Hematologic Malignancies: Regulatory
Considerations for Use of Minimal Residual Disease in Development of
Drug and Biological Products for Treatment.'' 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
This guidance refers to previously approved collections of
information found in FDA regulations. 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. 3501-3520). The
collection of information in 21 CFR part 312 for submitting INDs has
been approved under OMB control
[[Page 4670]]
number 0910-0014. The collection of information in 21 CFR part 314 for
the submission of new drug applications has been approved under OMB
control number 0910-0001. The submission of special protocol
assessments has been approved under OMB control number 0910-0470. The
submission of biologics license applications has been approved under
OMB control number 0910-0338. The submission of investigational device
exemptions has been approved under OMB control number 0910-0078.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or
https://www.regulations.gov.
Dated: January 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01312 Filed 1-24-20; 8:45 am]
BILLING CODE 4164-01-P
