Notice of Followup to Notice of Public Hearing and Request for Comments on Devices Proposed for a New Use With an Approved, Marketed Drug, 27419 [2020-09832]
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Notices
‘‘Cytomegalovirus in Transplantation:
Developing Drugs to Treat or Prevent
Disease.’’ The purpose of this final
guidance is to assist sponsors in the
clinical development of drugs to treat or
prevent 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 biological
products to support an indication for
treating or preventing CMV disease in
post-transplant populations. This
guidance does not address drug
development for treating or preventing
congenital CMV infection or CMV
infection in patients other than those
undergoing SOT or HSCT. This
guidance finalizes the draft guidance of
the same name issued on May 21, 2018
(83 FR 23463). Changes in this final
guidance compared with the previous
draft guidance include:
• Clarification of the use of CMV
DNAemia as a validated surrogate
endpoint for use in certain clinical
trials of CMV treatment or prevention
• Clarification that nonclinical
combination studies for drugs to be
used in combination are generally not
needed
• Inclusion of updated background
information to reflect the current
literature on preventing CMV in
transplant recipients
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Cytomegalovirus in
Transplantation: Developing Drugs to
Treat or Prevent Disease.’’ 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 collections of information in
21 CFR parts 312, 314, and 601 have
been approved under OMB control
numbers 0910–0014, 0910–0001, and
0910–0038, respectively.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidance-
VerDate Sep<11>2014
17:46 May 07, 2020
Jkt 250001
compliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: May 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09864 Filed 5–7–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5319]
Notice of Followup to Notice of Public
Hearing and Request for Comments on
Devices Proposed for a New Use With
an Approved, Marketed Drug
AGENCY:
Dated: May 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09832 Filed 5–7–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a followup on a
Federal Register document issued on
September 26, 2017, that announced a
public hearing and requested comments
on a potential approach to enable device
sponsors to obtain marketing
authorization for their products labeled
for a new use with an approved,
marketed drug when the sponsor for the
approved drug does not wish to pursue
or collaborate on the new use, referred
to in the notice as devices referencing
drugs (DRDs). After further
consideration and in light of the
comments received, FDA does not
intend to pursue the potential approach
described in the referenced Federal
Register document at this time.
FOR FURTHER INFORMATION CONTACT: John
Barlow Weiner, Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5130, Silver Spring,
MD 20993, 301–796–8941,
combination@fda.gov.
SUPPLEMENTARY INFORMATION: FDA
issued a Federal Register document on
September 26, 2017 (82 FR 44803),
entitled ‘‘Devices Proposed for a New
Use With an Approved, Marketed Drug;
Public Hearing; Request for Comments’’.
The document announced a public
hearing and requested comments on a
potential approach to enable device
sponsors to obtain marketing
authorization for their products labeled
for a new use with an approved,
marketed drug when the sponsor for the
approved drug does not wish to pursue
or collaborate on the new use. Such new
uses generally involve a change in how
SUMMARY:
PO 00000
the drug is used or administered, such
as a change in dose, route, or rate of
administration, or use of the approved
drug for an indication for which it is not
approved. As discussed in the
document, such DRDs raise unique
public health, scientific, regulatory, and
legal issues, which the potential
approach was intended to address.
However, after further consideration
and in light of the comments received
during the public hearing and submitted
to the docket, FDA does not intend to
pursue the potential approach described
in the document at this time.
Food and Drug Administration,
HHS.
ACTION:
27419
Frm 00068
Fmt 4703
Sfmt 4703
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: The Teaching Health
Center Graduate Medical Education
Program Reconciliation Tool, OMB No.
0915–0342—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than June 8, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
DATES:
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Notices]
[Page 27419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09832]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5319]
Notice of Followup to Notice of Public Hearing and Request for
Comments on Devices Proposed for a New Use With an Approved, Marketed
Drug
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a followup on a Federal Register document issued on
September 26, 2017, that announced a public hearing and requested
comments on a potential approach to enable device sponsors to obtain
marketing authorization for their products labeled for a new use with
an approved, marketed drug when the sponsor for the approved drug does
not wish to pursue or collaborate on the new use, referred to in the
notice as devices referencing drugs (DRDs). After further consideration
and in light of the comments received, FDA does not intend to pursue
the potential approach described in the referenced Federal Register
document at this time.
FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5130, Silver Spring, MD 20993, 301-796-8941,
[email protected].
SUPPLEMENTARY INFORMATION: FDA issued a Federal Register document on
September 26, 2017 (82 FR 44803), entitled ``Devices Proposed for a New
Use With an Approved, Marketed Drug; Public Hearing; Request for
Comments''. The document announced a public hearing and requested
comments on a potential approach to enable device sponsors to obtain
marketing authorization for their products labeled for a new use with
an approved, marketed drug when the sponsor for the approved drug does
not wish to pursue or collaborate on the new use. Such new uses
generally involve a change in how the drug is used or administered,
such as a change in dose, route, or rate of administration, or use of
the approved drug for an indication for which it is not approved. As
discussed in the document, such DRDs raise unique public health,
scientific, regulatory, and legal issues, which the potential approach
was intended to address. However, after further consideration and in
light of the comments received during the public hearing and submitted
to the docket, FDA does not intend to pursue the potential approach
described in the document at this time.
Dated: May 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09832 Filed 5-7-20; 8:45 am]
BILLING CODE 4164-01-P
