Attachment B 60 Day FRN 0386 Delta States

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Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Notices

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drugs because breast cancer in males is
rare. This has resulted in limited FDAapproved treatment options for males.
Clinical management of male breast
cancer is generally based on experience
with and data from females with breast
cancer, rather than on data from
prospective, randomized clinical trials.
The draft guidance recommends
sponsors discuss their breast cancer
drug development plan early in
development with CDER or CBER, as
applicable. The draft guidance
recommends that eligibility criteria for
clinical trials of breast cancer drugs
allow for inclusion of males. When
males have not been included or when
inclusion of males is very limited in
clinical trials for breast cancer drugs,
the guidance includes clinical
development recommendations for
when no difference in efficacy or safety
is anticipated between males and
females based on the drug’s mechanism
of action and for when there is a
concern for differential efficacy or safety
between males and females.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Male Breast Cancer: Developing
Drugs 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. 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This draft guidance refers to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 collections
of information in 21 CFR 312 have been
approved under OMB control number
0910–0014; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR part 601 have
been approved under 0910–0338; the
collections of information in 21 CFR
201.56 and 201.57 have been approved
under OMB control number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either

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https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://
www.regulations.gov.
Dated: August 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18363 Filed 8–26–19; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Delta States
Rural Development Network Grant
Program; OMB No. 0915–0386—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than October 28, 2019.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
SUMMARY:

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information, please include the ICR title
for reference.
Information Collection Request Title:
Delta States Rural Development
Network Grant Program, OMB No.
0915–0386—Extension
Abstract: The Delta States Rural
Development Network Grant (Delta)
Program is authorized by the Public
Health Service Act, Section 330A(f) (42
U.S.C. 254c(f)), as Public Law 114–53.
The Delta Program supports projects
that demonstrate evidence based and/or
promising approaches around
cardiovascular disease, diabetes, acute
ischemic stroke or obesity in order to
improve health status in rural
communities throughout the Delta
Region. Key features of Delta Programsupported projects are collaboration,
adoption of an evidence-based
approach, demonstration of health
outcomes, program replicability, and
sustainability.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data useful to the program and
to enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993 (Pub. L. 103–62).
These measures cover the principal
topic areas of interest to the Federal
Office of Rural Health Policy (FORHP)
including the following: (a) Access to
care, (b) population demographics, (c)
staffing, (d) sustainability, (e) project
specific domains, and (f) health related
clinical measures. These measures
speak to FORHP’s progress toward
meeting the goals set.
Likely Respondents: Recipients of the
Delta States Rural Development
Network Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.

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Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Total
responses

Average
burden per
response
(in hours)

Total
burden hours

Delta States Rural Development Network Program Performance Improvement Measurement System ................

12

1

12

1.66

* 20

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

12

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

12

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

20

* Number is rounded to the nearest whole number.

HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–18425 Filed 8–26–19; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Evidence-Based Telehealth
Network Program Measures, OMB No.
0906–xxxx—NEW
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

SUMMARY:

the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than September 26,
2019.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
[email protected] or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
[email protected] or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Evidence-Based Telehealth Network
Program Measures, OMB No. 0906–
xxxx—NEW.
Abstract: This ICR is for a new
approval of measures for the Federal
Office of Rural Health Policy’s Office of
Advancement of Telehealth programs.
Specifically, grants administered in
accordance with the following
legislative statute (ii) Section 711(b) of
the Social Security Act (42 U.S.C.
912(b)), as amended. The purpose of
these programs are to provide grants
that demonstrate how telehealth
programs and networks can improve
access to quality health care services in
rural, frontier, and underserved
communities. These grants will work to:
(a) Expand access to, coordinate, and
improve the quality of health care
services; (b) improve and expand the
training of health care providers; and (c)
expand and improve the quality of
health information available to health
care providers and patients and their

families for decision-making. In
addition, these grants will help HRSA
assess the effectiveness of evidence
based practices with the use of
telehealth for patients, providers, and
payers.
A 60-day notice was published in the
Federal Register on April 08, 2019, vol.
84, No. 67; pp. 13936. There were no
public comments.
Need and Proposed Use of the
Information: The measures will enable
HRSA and HRSA to capture awardeelevel and aggregate data that illustrate
the impact and scope of federal funding
along with assessing these efforts. The
measures cover the principal topic areas
of interest to HRSA including: (a)
Population demographics; (b) access to
health care; (c) cost savings and costeffectiveness; and (d) clinical outcomes.
Likely Respondents: Award recipients
of the Evidence Based Telehealth
Network Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.

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TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Evidence-Based Telehealth Network Program Report ........
Telehealth Performance Measurement Report ...................

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Number of
responses per
respondent

50
50

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Total
responses

12
1

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600
50

27AUN1

Average
burden per
response
(in hours)
14
5

Total
burden
hours
8,400
250