83 FR 52225 - Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 200 (October 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 200 (October 16, 2018)
| Page Range | 52225-52226 | |
| FR Document | 2018-22436 |
[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)] [Notices] [Pages 52225-52226] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22436] [[Page 52225]] ----------------------------------------------------------------------- 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Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.'' This draft guidance is intended to assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug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 the treatment of specific hematologic malignancies. DATES: Submit either electronic or written comments on the draft guidance by December 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or 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 draft guidance for industry entitled ``Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.'' This draft guidance is intended to assist 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 the treatment of specific hematologic malignancies. 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 [[Page 52226]] on regulatory considerations for use of MRD in drug and biological products in development for hematologic malignancies. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information 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 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 collection of information in the draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm590547.pdf) has been approved under OMB control number 0910-0429. 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 draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: October 10, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22436 Filed 10-15-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Notices 52225
DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: https://www.gpo.gov/
HUMAN SERVICES public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the 23389.pdf.
Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
[Docket No. FDA–2018–D–3090] Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
Written/Paper Submissions
Hematologic Malignancies: Regulatory received, go to https://
Considerations for Use of Minimal Submit written/paper submissions as www.regulations.gov and insert the
Residual Disease in Development of follows: docket number, found in brackets in the
Drug and Biological Products for • Mail/Hand delivery/Courier (for heading of this document, into the
Treatment; Draft Guidance for written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Industry; Availability Management Staff (HFA–305), Food and and/or go to the Dockets Management
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
HHS. • For written/paper comments You may submit comments on any
ACTION: Notice of availability. submitted to the Dockets Management guidance at any time (see 21 CFR
Staff, FDA will post your comment, as 10.115(g)(5)).
SUMMARY: The Food and Drug well as any attachments, except for
Administration (FDA or Agency) is Submit written requests for single
information submitted, marked and copies of the draft guidance to the
announcing the availability of a draft identified, as confidential, if submitted
guidance for industry entitled Division of Drug Information, Center for
as detailed in ‘‘Instructions.’’ Drug Evaluation and Research, Food
‘‘Hematologic Malignancies: Regulatory Instructions: All submissions received
Considerations for Use of Minimal and Drug Administration, 10001 New
must include the Docket No. FDA–
Residual Disease in Development of Hampshire Ave., Hillandale Building,
2018–D–3090 for ‘‘Hematologic
Drug and Biological Products for Malignancies: Regulatory 4th Floor, Silver Spring, MD 20993–
Treatment.’’ This draft guidance is Considerations for Use of Minimal 0002, or Office of Communication,
intended to assist sponsors planning to Residual Disease in Development of Outreach, and Development, Center for
use minimal residual disease (MRD) as Drug and Biological Products for Biologics Evaluation and Research,
a biomarker in clinical trials conducted Treatment.’’ Received comments will be Food and Drug Administration, 10903
under an investigational new drug placed in the docket and, except for New Hampshire Ave., Bldg. 71, Rm.
application (IND) or to support those submitted as ‘‘Confidential 3128, Silver Spring, MD 20993–0002.
marketing approval of drugs and Submissions,’’ publicly viewable at Send one self-addressed adhesive label
biological products for the treatment of https://www.regulations.gov or at the to assist that office in processing your
specific hematologic malignancies. Dockets Management Staff between 9 requests. See the SUPPLEMENTARY
a.m. and 4 p.m., Monday through INFORMATION section for electronic
DATES: Submit either electronic or
Friday. access to the draft guidance document.
written comments on the draft guidance
by December 17, 2018 to ensure that the • Confidential Submissions—To FOR FURTHER INFORMATION CONTACT:
Agency considers your comment on this submit a comment with confidential Nicole Gormley, Center for Drug
draft guidance before it begins work on information that you do not wish to be Evaluation and Research, Food and
the final version of the guidance. made publicly available, submit your Drug Administration, 10903 New
ADDRESSES: You may submit comments comments only as a written/paper Hampshire Ave., Bldg. 22, Rm. 2310,
on any guidance at any time as follows: submission. You should submit two Silver Spring, MD 20993–0002, 240–
copies total. One copy will include the 402–0210; or Stephen Ripley, Center for
Electronic Submissions information you claim to be confidential Biologics Evaluation and Research,
Submit electronic comments in the with a heading or cover note that states Food and Drug Administration, 10903
following way: ‘‘THIS DOCUMENT CONTAINS New Hampshire Ave., Bldg. 71, Rm.
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The 7301, Silver Spring, MD 20993–0002,
https://www.regulations.gov. Follow the Agency will review this copy, including 240–402–7911.
instructions for submitting comments. the claimed confidential information, in SUPPLEMENTARY INFORMATION:
Comments submitted electronically, its consideration of comments. The
second copy, which will have the I. Background
including attachments, to https://
www.regulations.gov will be posted to claimed confidential information FDA is announcing the availability of
the docket unchanged. Because your redacted/blacked out, will be available a draft guidance for industry entitled
comment will be made public, you are for public viewing and posted on ‘‘Hematologic Malignancies: Regulatory
solely responsible for ensuring that your https://www.regulations.gov. Submit Considerations for Use of Minimal
comment does not include any both copies to the Dockets Management Residual Disease in Development of
confidential information that you or a Staff. If you do not wish your name and Drug and Biological Products for
third party may not wish to be posted, contact information to be made publicly Treatment.’’ This draft guidance is
such as medical information, your or available, you can provide this intended to assist sponsors planning to
anyone else’s Social Security number, or information on the cover sheet and not use MRD as a biomarker in clinical trials
confidential business information, such in the body of your comments and you conducted under an IND or to support
as a manufacturing process. Please note must identify this information as marketing approval of drugs and
amozie on DSK3GDR082PROD with NOTICES1
that if you include your name, contact ‘‘confidential.’’ Any information marked biological products for the treatment of
information, or other information that as ‘‘confidential’’ will not be disclosed specific hematologic malignancies.
identifies you in the body of your except in accordance with 21 CFR 10.20 This draft guidance is being issued
comments, that information will be and other applicable disclosure law. For consistent with FDA’s good guidance
posted on https://www.regulations.gov. more information about FDA’s posting practices regulation (21 CFR 10.115).
• If you want to submit a comment of comments to public dockets, see 80 The draft guidance, when finalized, will
with confidential information that you FR 56469, September 18, 2015, or access represent the current thinking of FDA
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![52226 Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Notices
on regulatory considerations for use of DEPARTMENT OF HEALTH AND supplemental activities pertaining to
MRD in drug and biological products in HUMAN SERVICES opioids currently undertaken by the
development for hematologic state agency or territory and will
malignancies. It does not establish any Performance Review Board Members support a comprehensive response to
rights for any person and is not binding the opioid epidemic.
Title 5, U.S.C. Section 4314(c)(4) of SAMHSA received approval from
on FDA or the public. You can use an the Civil Service Reform Act of 1978,
alternative approach if it satisfies the OMB in September 2017 to collect
Public Law 95–454, requires that the performance data from Opioid State
requirements of the applicable statutes appointment of Performance Review Targeted Response (STR) grantees (OMB
and regulations. This guidance is not Board Members be published in the No. 0930–0378). However, SAMHSA
subject to Executive Order 12866. Federal Register. The following persons omitted a data collection table (Table E)
II. Paperwork Reduction Act of 1995 may be named to serve on the in the original OMB request. This data
Performance Review Boards or Panels, table is currently in use by Opioid STR
This draft guidance refers to which oversee the evaluation of grantees, who are reporting Table E data
previously approved collections of performance appraisals of Senior to SAMHSA on a semi-annual basis. In
information found in FDA regulations. Executive Service members of the order to correct this violation, SAMHSA
These collections of information are Department of Health and Human is now seeking OMB approval for a new
subject to review by the Office of Services. data collection package that includes
Management and Budget (OMB) under not only the instruments originally
Employee last name Employee first name approved by OMB in September 2017,
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of Alvarez Karl
but also this additional data collection
information in 21 CFR part 312 for Bush Laina table. It is important for SAMHSA to
submitting INDs has been approved Cash Lester continue to collect this information in
under OMB control number 0910–0014. Hoffman Darrell order to assess the impact of funding
The collection of information in 21 CFR Kerr Lawrence from the Opioid STR program on
Walker Edwin increasing access to prevention
part 314 for the submission of new drug
strategies, as well as treatment and
applications has been approved under
Dated: October 10, 2018. recovery services that address the
OMB control number 0910–0001. The opioid crisis. Additionally, this data
collection of information in the draft Charles H. McEnerney III,
will provide SAMHSA with critical
guidance for industry entitled ‘‘Formal Director, Executive and Scientific Resources
Division. information to effectively manage the
Meetings Between the FDA and Opioid STR program, to help states and
Sponsors or Applicants of PDUFA [FR Doc. 2018–22491 Filed 10–15–18; 8:45 am]
territories adopt, or scale-up, effective
Products’’ (available at https:// BILLING CODE 4151–17–P
practices and policies, and to help
www.fda.gov/ucm/groups/fdagov- prepare to implement the new State
public/@fdagov-drugs-gen/documents/ Opioid Response grant program.
DEPARTMENT OF HEALTH AND
document/ucm590547.pdf) has been The primary purpose of the Opioid
HUMAN SERVICES
approved under OMB control number STR program is to address the opioid
0910–0429. The submission of special Substance Abuse and Mental Health crisis by increasing access to treatment,
protocol assessments has been approved Services Administration reducing unmet treatment need, and
under OMB control number 0910–0470. reducing opioid overdose related deaths
Agency Information Collection through the provision of prevention,
The submission of biologics license treatment and recovery activities for
applications has been approved under Activities: Submission for Office of
Management and Budget (OMB) opioid use disorder (OUD) (including
OMB control number 0910–0338. The prescription opioids as well as illicit
Review; Comment Request
submission of investigational device drugs such as heroin).
exemptions has been approved under Periodically, the Substance Abuse and There are 57 (states and jurisdictions)
OMB control number 0910–0078. Mental Health Services Administration award recipients in this program. All
(SAMHSA) will publish a summary of funded states and jurisdictions are
III. Electronic Access information collection requests under asked to report on their implementation
Persons with access to the internet OMB review, in compliance with the and performance through an online data
may obtain the draft guidance at either Paperwork Reduction Act (44 U.S.C. collection system. Award recipients
https://www.fda.gov/Drugs/Guidance Chapter 35). To request a copy of these report performance on the following
ComplianceRegulatoryInformation/ documents, call the SAMHSA Reports measures specific to this program:
Guidances/default.htm, https:// Clearance Officer on (240) 276–1243. Number of people who receive OUD
treatment, number of people who
www.fda.gov/BiologicsBloodVaccines/ Project: State Targeted Response to the
receive OUD recovery services, number
GuidanceComplianceRegulatory Opioid Crisis Grant Program Mid-Year
of providers implementing medication-
Information/Guidances/default.htm, or and End-Year Performance Reports—
assisted treatment, and the number of
https://www.regulations.gov. (OMB No. 0930–0378)—in Use Without OUD prevention and treatment
OMB Approval providers trained, to include nurse
Dated: October 10, 2018.
Leslie Kux, The Substance Abuse and Mental practitioners, physician assistants, as
amozie on DSK3GDR082PROD with NOTICES1
Associate Commissioner for Policy.
Health Services Administration well as physicians, nurses, counselors,
(SAMHSA) is authorized under Section social workers, case managers, etc. This
[FR Doc. 2018–22436 Filed 10–15–18; 8:45 am]
1003 of the 21st Century Cures Act, as information is collected at the mid-point
BILLING CODE 4164–01–P amended, to support a grant program, and conclusion of each grant award
for up to 2 years, that addresses the year. Additionally, each award recipient
VerDate Sep<11>2014 18:44 Oct 15, 2018 Jkt 247001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1](https://thefederalregister.org/doc/83_FR_52425/page/2.svg)
Document Created: 2018-10-15 23:42:13
Document Modified: 2018-10-15 23:42:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by December 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| 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. | |
| FR Citation | 83 FR 52225 |
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