83_FR_23561 83 FR 23463 - Cytomegalovirus in Transplantation: Developing Drugs To Treat or Prevent Disease; Draft Guidance for Industry; Availability

83 FR 23463 - Cytomegalovirus in Transplantation: Developing Drugs To Treat or Prevent Disease; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 98 (May 21, 2018)

Page Range23463-23464
FR Document2018-10733

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.'' The purpose of this guidance is to assist sponsors in all phases of development of drugs and biologics for the treatment or prevention of cytomegalovirus (CMV) disease in patients who have undergone solid organ transplantation (SOT) or hematopoietic stem cell transplantation (HSCT).

Federal Register, Volume 83 Issue 98 (Monday, May 21, 2018) 
[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23463-23464]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2018-D-1711]


Cytomegalovirus in Transplantation: Developing Drugs To Treat or 
Prevent Disease; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Cytomegalovirus in Transplantation: Developing Drugs to Treat or 
Prevent Disease.'' The purpose of this guidance is to assist sponsors 
in all phases of development of drugs and biologics for the treatment 
or prevention of cytomegalovirus (CMV) disease in patients who have 
undergone solid organ transplantation (SOT) or hematopoietic stem cell 
transplantation (HSCT).

DATES: Submit either electronic or written comments on the draft 
guidance by July 20, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-1711 for ``Cytomegalovirus in Transplantation: Developing 
Drugs to Treat or Prevent Disease; Draft Guidance for Industry; 
Availability.'' 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. 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: Jeffrey Murray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Cytomegalovirus in Transplantation: Developing Drugs to 
Treat or Prevent

[[Page 23464]]

Disease.'' The purpose of this guidance is to assist sponsors in the 
clinical development of drugs for the treatment or prevention of CMV 
disease in patients who have undergone SOT or HSCT. Specifically, this 
guidance addresses FDA's current thinking regarding the overall 
development program and clinical trial designs for the development of 
drugs and biologics to support an indication for the treatment or 
prevention of CMV disease in post-transplant populations. This guidance 
does not address drug development for the prevention or treatment of 
congenital CMV infection or CMV infection in patients other than those 
undergoing SOT or HSCT.
    This guidance also discusses the use of CMV DNAemia (CMV 
deoxyribonucleic acid in blood determined by polymerase chain reaction, 
an indirect measure of CMV viremia) as a surrogate endpoint in trials 
designed to support accelerated approval.
    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 developing 
drugs to treat or prevent CMV disease in transplantation. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

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 or 
https://www.regulations.gov.

    Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10733 Filed 5-18-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices 23463 practices regulation (21 CFR 10.115). Electronic Submissions with a heading or cover note that states The guidance represents the current Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS thinking of FDA on establishing following way: CONFIDENTIAL INFORMATION.’’ The effectiveness for drugs intended to treat • Federal eRulemaking Portal: Agency will review this copy, including male hypogonadotropic hypogonadism https://www.regulations.gov. Follow the the claimed confidential information, in attributed to nonstructural disorders. It instructions for submitting comments. its consideration of comments. The does not establish any rights for any Comments submitted electronically, second copy, which will have the person and is not binding on FDA or the including attachments, to https:// claimed confidential information public. You can use an alternative www.regulations.gov will be posted to redacted/blacked out, will be available approach if it satisfies the requirements the docket unchanged. Because your for public viewing and posted on of the applicable statutes and comment will be made public, you are https://www.regulations.gov. Submit regulations. This guidance is not subject solely responsible for ensuring that your both copies to the Dockets Management to Executive Order 12866. comment does not include any Staff. If you do not wish your name and confidential information that you or a contact information to be made publicly II. Electronic Access third party may not wish to be posted, available, you can provide this Persons with access to the internet such as medical information, your or information on the cover sheet and not may obtain the guidance at either anyone else’s Social Security number, or in the body of your comments and you https://www.fda.gov/Drugs/Guidance confidential business information, such must identify this information as ComplianceRegulatoryInformation/ as a manufacturing process. Please note ‘‘confidential.’’ Any information marked Guidances/default.htm or https:// that if you include your name, contact as ‘‘confidential’’ will not be disclosed www.regulations.gov. information, or other information that except in accordance with 21 CFR 10.20 Dated: May 15, 2018. identifies you in the body of your and other applicable disclosure law. For comments, that information will be more information about FDA’s posting Leslie Kux, posted on https://www.regulations.gov. of comments to public dockets, see 80 Associate Commissioner for Policy. • If you want to submit a comment FR 56469, September 18, 2015, or access [FR Doc. 2018–10732 Filed 5–18–18; 8:45 am] the information at: https://www.gpo.gov/ with confidential information that you BILLING CODE 4164–01–P do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- public, submit the comment as a 23389.pdf. written/paper submission and in the Docket: For access to the docket to DEPARTMENT OF HEALTH AND read background documents or the HUMAN SERVICES manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments Food and Drug Administration received, go to https:// Written/Paper Submissions www.regulations.gov and insert the Submit written/paper submissions as docket number, found in brackets in the [Docket No. FDA 2018–D–1711] heading of this document, into the follows: • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts Cytomegalovirus in Transplantation: written/paper submissions): Dockets and/or go to the Dockets Management Developing Drugs To Treat or Prevent Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, Disease; Draft Guidance for Industry; Drug Administration, 5630 Fishers Rockville, MD 20852. Availability Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any AGENCY: Food and Drug Administration, • For written/paper comments guidance at any time (see 21 CFR HHS. submitted to the Dockets Management 10.115(g)(5)). Staff, FDA will post your comment, as Submit written requests for single ACTION: Notice of availability. copies of the draft guidance to the well as any attachments, except for information submitted, marked and Division of Drug Information, Center for SUMMARY: The Food and Drug Drug Evaluation and Research, Food Administration (FDA or Agency) is identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New announcing the availability of a draft Hampshire Ave., Hillandale Building, guidance for industry entitled Instructions: All submissions received must include the Docket No. FDA 2018– 4th Floor, Silver Spring, MD 20993– ‘‘Cytomegalovirus in Transplantation: 0002. Send one self-addressed adhesive Developing Drugs to Treat or Prevent D–1711 for ‘‘Cytomegalovirus in Transplantation: Developing Drugs to label to assist that office in processing Disease.’’ The purpose of this guidance your requests. See the SUPPLEMENTARY is to assist sponsors in all phases of Treat or Prevent Disease; Draft Guidance for Industry; Availability.’’ Received INFORMATION section for electronic development of drugs and biologics for comments will be placed in the docket access to the draft guidance document. the treatment or prevention of cytomegalovirus (CMV) disease in and, except for those submitted as FOR FURTHER INFORMATION CONTACT: patients who have undergone solid ‘‘Confidential Submissions,’’ publicly Jeffrey Murray, Center for Drug organ transplantation (SOT) or viewable at https://www.regulations.gov Evaluation and Research, Food and hematopoietic stem cell transplantation or at the Dockets Management Staff Drug Administration, 10903 New (HSCT). between 9 a.m. and 4 p.m., Monday Hampshire Ave., Bldg. 22, Rm. 6360, through Friday. Silver Spring, MD 20993–0002, 301– DATES: Submit either electronic or • Confidential Submissions—To 796–1500. sradovich on DSK3GMQ082PROD with NOTICES written comments on the draft guidance submit a comment with confidential SUPPLEMENTARY INFORMATION: by July 20, 2018 to ensure that the information that you do not wish to be Agency considers your comment on this made publicly available, submit your I. Background draft guidance before it begins work on comments only as a written/paper FDA is announcing the availability of the final version of the guidance. submission. You should submit two a draft guidance for industry entitled ADDRESSES: You may submit comments copies total. One copy will include the ‘‘Cytomegalovirus in Transplantation: on any guidance at any time as follows: information you claim to be confidential Developing Drugs to Treat or Prevent VerDate Sep<11>2014 18:20 May 18, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1

23464 Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices Disease.’’ The purpose of this guidance DEPARTMENT OF HEALTH AND that if you include your name, contact is to assist sponsors in the clinical HUMAN SERVICES information, or other information that development of drugs for the treatment identifies you in the body of your or prevention of CMV disease in Food and Drug Administration comments, that information will be patients who have undergone SOT or [Docket No. FDA–2018–N–0821] posted on https://www.regulations.gov. HSCT. Specifically, this guidance • If you want to submit a comment addresses FDA’s current thinking Agency Information Collection with confidential information that you regarding the overall development Activities; Proposed Collection; do not wish to be made available to the program and clinical trial designs for Comment Request; Investigation of public, submit the comment as a the development of drugs and biologics Consumer Perceptions of Expressed written/paper submission and in the to support an indication for the Modified Risk Claims manner detailed (see ‘‘Written/Paper treatment or prevention of CMV disease Submissions’’ and ‘‘Instructions’’). AGENCY: Food and Drug Administration, in post-transplant populations. This HHS. Written/Paper Submissions guidance does not address drug ACTION: Notice. Submit written/paper submissions as development for the prevention or follows: treatment of congenital CMV infection SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for or CMV infection in patients other than Administration (FDA or Agency) is written/paper submissions): Dockets those undergoing SOT or HSCT. announcing an opportunity for public Management Staff (HFA–305), Food and This guidance also discusses the use comment on the proposed collection of Drug Administration, 5630 Fishers of CMV DNAemia (CMV certain information by the Agency. Lane, Rm. 1061, Rockville, MD 20852. deoxyribonucleic acid in blood Under the Paperwork Reduction Act of • For written/paper comments 1995 (PRA), Federal Agencies are submitted to the Dockets Management determined by polymerase chain required to publish notice in the Staff, FDA will post your comment, as reaction, an indirect measure of CMV Federal Register concerning each well as any attachments, except for viremia) as a surrogate endpoint in trials proposed collection of information and information submitted, marked and designed to support accelerated to allow 60 days for public comment in identified, as confidential, if submitted approval. response to the notice. This notice as detailed in ‘‘Instructions.’’ This draft guidance is being issued solicits comments on the investigation Instructions: All submissions received consistent with FDA’s good guidance of consumer perceptions of expressed must include the Docket No. FDA– practices regulation (21 CFR 10.115). modified risk claims. 2018–N–0821 for ‘‘Investigation of The draft guidance, when finalized, will DATES: Submit either electronic or Consumer Perceptions of Expressed represent the current thinking of FDA written comments on the collection of Modified Risk Claims.’’ Received on developing drugs to treat or prevent information by July 20, 2018. comments, those filed in a timely CMV disease in transplantation. It does ADDRESSES: You may submit comments manner (see ADDRESSES), will be placed not establish any rights for any person as follows. Please note that late, in the docket and, except for those and is not binding on FDA or the public. untimely filed comments will not be submitted as ‘‘Confidential You can use an alternative approach if considered. Electronic comments must Submissions,’’ publicly viewable at it satisfies the requirements of the be submitted on or before July 20, 2018. https://www.regulations.gov or at the applicable statutes and regulations. This The https://www.regulations.gov Dockets Management Staff between 9 guidance is not subject to Executive electronic filing system will accept a.m. and 4 p.m., Monday through Order 12866. comments until midnight Eastern Time Friday. at the end of July 20, 2018. Comments • Confidential Submissions—To II. Paperwork Reduction Act of 1995 submit a comment with confidential received by mail/hand delivery/courier (for written/paper submissions) will be information that you do not wish to be This draft guidance refers to considered timely if they are made publicly available, submit your previously approved collections of postmarked or the delivery service comments only as a written/paper information that are subject to review by acceptance receipt is on or before that submission. You should submit two the Office of Management and Budget date. copies total. One copy will include the (OMB) under the Paperwork Reduction information you claim to be confidential Act of 1995 (44 U.S.C. 3501–3520). The Electronic Submissions with a heading or cover note that states collections of information in 21 CFR ‘‘THIS DOCUMENT CONTAINS Submit electronic comments in the parts 312 and 314 have been approved CONFIDENTIAL INFORMATION.’’ The following way: under OMB control numbers 0910–0014 • Federal eRulemaking Portal: Agency will review this copy, including and 0910–0001, respectively. https://www.regulations.gov. Follow the the claimed confidential information, in III. Electronic Access instructions for submitting comments. its consideration of comments. The Comments submitted electronically, second copy, which will have the Persons with access to the internet including attachments, to https:// claimed confidential information may obtain the draft guidance at either www.regulations.gov will be posted to redacted/blacked out, will be available https://www.fda.gov/Drugs/Guidance the docket unchanged. Because your for public viewing and posted on ComplianceRegulatoryInformation/ comment will be made public, you are https://www.regulations.gov. Submit Guidances/default.htm or https:// solely responsible for ensuring that your both copies to the Dockets Management sradovich on DSK3GMQ082PROD with NOTICES www.regulations.gov. comment does not include any Staff. If you do not wish your name and Dated: May 15, 2018. confidential information that you or a contact information to be made publicly third party may not wish to be posted, available, you can provide this Leslie Kux, such as medical information, your or information on the cover sheet and not Associate Commissioner for Policy. anyone else’s Social Security number, or in the body of your comments and you [FR Doc. 2018–10733 Filed 5–18–18; 8:45 am] confidential business information, such must identify this information as BILLING CODE 4164–01–P as a manufacturing process. Please note ‘‘confidential.’’ Any information marked VerDate Sep<11>2014 18:20 May 18, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1


Document Created: 2018-11-02 11:07:15
Document Modified: 2018-11-02 11:07:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on the draft guidance by July 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactJeffrey Murray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301- 796-1500.
FR Citation83 FR 23463 
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