30-day FRN

20698

Federal Register / Vol. 85, No. 72 / Tuesday, April 14, 2020 / Notices

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Developers whose approved companion
diagnostics may be appropriate for
broader labeling are encouraged to
contact CDRH or CBER, as appropriate
to discuss. Developers of the companion
diagnostics discussed in the guidance as
an example should see the ‘‘Other Issues
for Consideration’’ section of this notice
for information regarding broader
labeling for those companion
diagnostics.
This guidance finalizes the draft
guidance entitled ‘‘Developing and
Labeling In Vitro Companion Diagnostic
Devices for a Specific Group or Class of
Oncology Therapeutic Products’’ dated
December 2018 (83 FR 63166).
Comments received on the draft
guidance were taken into consideration
when finalizing the guidance. Based on
the comments received, clarifications
were made and information regarding
the content of broader labeling was
added.
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 ‘‘Developing and
Labeling In Vitro Companion Diagnostic
Devices for a Specific Group of
Oncology Therapeutic Products.’’ 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. Other Issues for Consideration
Based on publicly available
information, which includes valid
scientific evidence (i.e., clinical and
scientific experience) with specific
companion diagnostics and the
associated therapeutic products, FDA
has concluded that certain statements
set forth in the FDA-approved labels of
these companion diagnostics, related to
intended use with therapeutic products,
can be modified. The specific
companion diagnostics are those
discussed as an example in the guidance
announced in this notice (i.e.,
companion diagnostics that identify
patients with NSCLC whose tumors
have EGFR exon 19 deletions or exon 21
(L858R) substitution mutations and are
suitable for treatment with a tyrosine
kinase inhibitor approved by FDA for
that indication). FDA believes it is
appropriate for sponsors to consider
modifying the intended use of these
companion diagnostics to describe the
specific group of oncology therapeutic
products, rather than listing individual
therapeutic product(s). The guidance
states that, rather than listing individual
therapeutic product(s), the intended use

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for the indication for the specific
companion diagnostics would be,
‘‘identifying patients with NSCLC
whose tumors have EGFR exon 19
deletions or exon 21 (L858R)
substitution mutations and are suitable
for treatment with a tyrosine kinase
inhibitor approved by FDA for that
indication.’’ It is possible for the
companion diagnostics to also have
other indications, not captured by the
broader indication. FDA encourages the
submission of PMA supplements,
identifying the change and referring to
this notice as the reason for the change,
to request modification of the intended
use of these companion diagnostics.
This broader labeling may enable greater
flexibility for clinicians in choosing the
most appropriate therapeutic product
based on a patient’s biomarker status.
In the Federal Register document that
announced the availability of the draft
guidance, FDA requested feedback on
specific issues, including challenges
with developing the evidence needed to
support broader companion diagnostic
labeling, challenges with submitting a
PMA supplement to broaden the
labeling of an approved companion
diagnostic and actions FDA can take to
facilitate or encourage broader
companion diagnostic labeling in
oncology. Comments that stakeholders
submitted to the docket for the draft
guidance are generally supportive of the
concept of broader labeling for
companion diagnostics in oncology to
facilitate the treatment of patients with
cancer. To encourage implementation of
broader labeling of companion
diagnostics in oncology, FDA is
finalizing the guidance and encouraging
submission of PMA supplements
containing the needed information for
FDA review of the modified labeling of
the companion diagnostics discussed in
the guidance as an example.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations and guidance.
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 collections
of information in 21 CFR parts 801 and
809 have been approved under OMB
control number 0910–0485; the
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 814, subparts A through E, have
been approved under OMB control
number 0910–0231; the collections of
information in 21 CFR part 814, subpart

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H have been approved under OMB
control number 0910–0332; the
collections of information in the
guidance document ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program’’ have been approved under
OMB control number 0910–0756; and
the collections of information in the
guidance ‘‘De Novo Classification
Process (Evaluation of Automatic Class
III Designation)’’ have been approved
under OMB control number 0910–0844.
IV. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https://
www.regulations.gov.
Dated: April 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–07816 Filed 4–13–20; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Early Career
Reviewer Program Online Application
and Vetting System (Center for
Scientific Review)
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
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
SUMMARY:

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20699

Federal Register / Vol. 85, No. 72 / Tuesday, April 14, 2020 / Notices
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Dr. Hope
Cummings, Project Clearance Liaison,
Center for Scientific Review, NIH, Room
4134, 6701 Rockledge Drive, Bethesda,
Maryland, 20892 or call non-toll-free
number (301) 402–4706 or Email your
request, including your address to:
[email protected]. Formal
requests for additional plans and
instruments must be requested in
writing.

FOR FURTHER INFORMATION CONTACT:

This
proposed information collection was
previously published in the Federal
Register on January 31, 2020, pages
5677–5678 (85 FR 21) and allowed 60
days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The Center
for Scientific Review (CSR), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.

SUPPLEMENTARY INFORMATION:

not had prior CSR review experience.
The goals of the program are to expose
these early career scientists to the peer
review experience so that they become
more competitive as applicants as well
as to enrich the existing pool of NIH
reviewers. Currently, the online
application software, the Early Career
Reviewer Application and Vetting
System, is accessed online by applicants
to the Early Career Reviewer Program
who provide information such as their
name, contact information, a description
of their areas of expertise, their study
section preferences, and their
professional Curriculum Vitae. This
Information Collection Request (ICR) is
to revise the Early Career Reviewer
Application and Vetting System to
include additional questions and be
more user friendly. Additional
questions are in line with NIH’s
renewed Interest in Diversity (NOT–
OD–20–031) and include questions such
as applicants’ race, ethnicity, gender,
disability, and disadvantage
backgrounds. Applicants can choose if
they would like to answer these
additional questions (i.e. optional).
Applicants are also now able to check
their eligibility before applying to the
program.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
505.

In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Early Career
Reviewer Program Online Application
and Vetting System—0925–0695,
REVISION—expiration date 05/31/2020,
Center for Scientific Review (CSR),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The Center for Scientific
Review (CSR) is the portal for NIH grant
applications and their review for
scientific merit. Our mission is to see
that all NIH grant applications receive
fair, independent, expert, and timely
reviews—free from inappropriate
influences—so NIH can fund the most
promising research. To accomplish this
goal, Scientific Review Officers (SRO)
form study sections consisting of
scientists who have the technical and
scientific expertise to evaluate the merit
of grant applications. Study section
members are generally scientists who
have established independent programs
of research as demonstrated by their
publications and their grant award
experiences.
The CSR Early Career Reviewer
program was developed to identify and
train qualified scientists who are early
in their scientific careers and who have

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondent

Average time
per response
(in hours)

Total annual
burden hour

Research scientists ..........................................................................................

1212

1

25/60

505

Total ..........................................................................................................

........................

1212

........................

505

Dated: March 30, 2020.
Hope M. Cummings,
Project Clearance Liaison, Center for
Scientific Review (CSR), National Institutes
of Health.

DEPARTMENT OF HOMELAND
SECURITY

[FR Doc. 2020–07708 Filed 4–13–20; 8:45 am]

[Internal Agency Docket No. FEMA–4485–
DR; Docket ID FEMA–2020–0001]

BILLING CODE 4140–01–P

Federal Emergency Management
Agency

Texas; Major Disaster and Related
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
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Number of
responses per
respondent

This is a notice of the
Presidential declaration of a major
disaster for the State of Texas (FEMA–
4485–DR), dated March 25, 2020, and
related determinations.

SUMMARY:

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The declaration was issued
March 25, 2020.

DATES:

FOR FURTHER INFORMATION CONTACT:

Dean Webster, Office of Response and
Recovery, Federal Emergency
Management Agency, 500 C Street SW,
Washington, DC 20472, (202) 646–2833.
Notice is
hereby given that, in a letter dated
March 25, 2020, the President issued a
major disaster declaration under the
authority of the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq.
(the ‘‘Stafford Act’’), as follows:

SUPPLEMENTARY INFORMATION:

I have determined that the emergency
conditions in the State of Texas resulting
from the Coronavirus Disease 2019 (COVID–
19) pandemic beginning on January 20, 2020,

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