Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Health Workforce Connector, OMB No. 0906-0031-Extension, 48708-48709 [2020-17635]
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Federal Register / Vol. 85, No. 156 / Wednesday, August 12, 2020 / Notices
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drug development plan early in
development with CDER or CBER, as
applicable. The 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This guidance finalizes the draft
guidance entitled ‘‘Male Breast Cancer:
Developing Drugs for Treatment’’ issued
on August 27, 2019. FDA considered
comments received on the draft
guidance as the guidance was finalized.
Changes from the draft to the final
guidance include the addition of
examples of topics for early discussion
with FDA and expectations regarding
nonclinical studies.
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 ‘‘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.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved FDA collections of
information. 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
part 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
OMB control number 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 guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidance-
VerDate Sep<11>2014
16:37 Aug 11, 2020
Jkt 250001
compliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: August 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17575 Filed 8–11–20; 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: Health
Workforce Connector, OMB No. 0906–
0031—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 13, 2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 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 paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Health Workforce Connector, OMB No.
0906–0031—Extension.
Abstract: More than just a job search
portal, the goal of the Health Workforce
Connector is to help connect skilled
professionals to communities in need by
allowing approved Site Points of
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Contact (POCs), including National
Health Service Corps (NHSC) and Nurse
Corps, to post available opportunities
and update site profiles. The Health
Workforce Connector provides a central
platform to connect participants,
including those in both the NHSC and
Nurse Corps programs, and facilities
that are approved for performance of
their NHSC or Nurse Corps service
obligation. The Health Workforce
Connector has become a resource that
engages any health care professional or
student interested in providing primary
care services in underserved
communities and with facilities in need
of health care providers. The Health
Workforce Connector also allows users
to create a profile, search for NHSC and
Nurse Corps sites, find job and training
opportunities, search for other
clinicians who are similarly interested
in working with underserved
populations, and be searchable by Site
POCs. Individuals can use the Health
Workforce Connector’s search capability
with Google Maps.
Need and Proposed Use of the
Information: Information will be
collected from users in the following
two ways:
(1) Account Creation: Creating an
account is optional, but to create an
account the user will be required to
enter their first name, last name, and
email address. Those are the only
mandatory fields in the profile account
creation process and will be used to
send an automated email allowing the
user to validate their login credentials.
This information will also be used to
validate any users who already exist
within the Bureau of Health Workforce
Management Information Systems
Solution (BMISS) database and allow an
initial import of existing data at the
request of the user.
(2) Profile Completion: Users may fill
out a profile, but this function will be
completely optional and will include
fields such as location, discipline,
specialty, and languages spoken. The
information collected, if ‘published’ by
the user, will allow internal BMISS Site
POCs to search for anyone who may be
a potential candidate for job
opportunities at the site. Users also have
the ability to make their profiles
searchable by other end users through a
security and privacy setting and can
make their profiles private at any time.
All information collected will be stored
within existing secure BMISS databases
and will be used internally for report
generation on an as-needed basis.
Likely Respondents: Potential users
will include individuals searching for a
health care job opportunity or an NHSC
or Nurse Corps health care facility, and
E:\FR\FM\12AUN1.SGM
12AUN1
48709
Federal Register / Vol. 85, No. 156 / Wednesday, August 12, 2020 / Notices
health care facilities searching for
potential candidates to fill open health
care job opportunities at their sites.
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.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Account Creation .................................................................
Complete Profile ..................................................................
15,600
9,400
1
1
15,600
9,400
.08
1
1,248
9,400
Total ..............................................................................
1 15,600
........................
15,600
........................
10,648
1 The
9,400 respondents who complete their profiles are a subset of the 15,600 respondents who create accounts.
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, Executive Secretariat.
[FR Doc. 2020–17635 Filed 8–11–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
Findings of research
misconduct have been made against
Zhiwei Wang, M.D. (Respondent),
former postdoctoral fellow, Department
of Pathology, Karmanos Cancer
Institute, Wayne State University
(WSU). Dr. Wang engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically National Cancer Institute
(NCI), National Institutes of Health
(NIH), grants P20 CA101936, P30
CA022453, R01 CA075059, R01
CA083695, R01 CA101870, R01
CA109389, R01CA131151, R01
CA132794, and U19 CA113317. The
administrative actions, including
debarment for a period of ten (10) years,
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
VerDate Sep<11>2014
16:37 Aug 11, 2020
Jkt 250001
were implemented beginning on July 21,
2020, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Elisabeth A. Handley, Director, Office of
Research Integrity, 1101 Wootton
Parkway, Suite 240, Rockville, MD
20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Zhiwei Wang, M.D., Wayne State
University: Based on the report of an
investigation conducted by WSU and
additional analysis conducted by ORI in
its oversight review, ORI found that Dr.
Zhiwei Wang, former postdoctoral
fellow, Department of Pathology,
Karmanos Cancer Institute, WSU,
engaged in research misconduct in
research supported by PHS funds,
specifically NCI, NIH, grants P20
CA101936, P30 CA022453, R01
CA075059, R01 CA083695, R01
CA101870, R01 CA109389,
R01CA131151, R01 CA132794, and U19
CA113317.
ORI found that Respondent engaged
in research misconduct by knowingly,
intentionally, and/or recklessly
falsifying data that were included in
grant applications R01 CA120008, R01
CA131151, and R01 CA131456
submitted to NCI, NIH; his 2006 Ph.D.
dissertation (hereafter referred to as the
‘‘Dissertation’’); and the following
published papers:
• Activated K-Ras and INK4a/Arf
deficiency promote aggressiveness of
pancreatic cancer by induction of EMT
consistent with cancer stem cell
phenotype. J Cell Physiol. 2013
Mar;228(3):556–62 (hereafter referred to
as ‘‘J Cell Physiol. 2013’’). Erratum in: J
Cell Physiol. 2014 Aug;229(8):1118.
Retraction in: J Cell Physiol. 2016
Oct;231(10):2304.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
• Activated K-ras and INK4a/Arf
deficiency cooperate during the
development of pancreatic cancer by
activation of Notch and NF-kB signaling
pathways. PLoS One 2011;6(6):e20537
(hereafter referred to as ‘‘PLoS One
2011’’). Erratum in: PLoS One
2014;9(6):e101032. Retraction in: PLoS
One. 2018 Oct 2;13(10):e0205289.
• Down-regulation of Notch-1 is
associated with Akt and FoxM1 in
inducing cell growth inhibition and
apoptosis in prostate cancer cells. J Cell
Biochem. 2011 Jan;112(1):78–88
(hereafter referred to as ‘‘J Cell Biochem.
2011’’). Retraction in: J Cell Biochem.
2016 Aug;117(8):1962.
• Down-regulation of Notch-1 and
Jagged-1 inhibits prostate cancer cell
growth, migration and invasion, and
induces apoptosis via inactivation of
Akt, mTOR, and NF-kB signaling
pathways. J Cell Biochem. 2010 Mar
1;109(4):726–36 (hereafter referred to as
‘‘J Cell Biochem. 2010’’). Retraction in:
J Cell Biochem. 2016 Aug;117(8):1960.
• TW–37, a small-molecule inhibitor
of Bcl-2, inhibits cell growth and
invasion in pancreatic cancer. Int J
Cancer 2008 Aug 15;123(4):958–66
(hereafter referred to as ‘‘Int J Cancer
2008’’). Retraction in: Int J Cancer. 2016
Nov 1;139(9):2146.
• Induction of growth arrest and
apoptosis in human breast cancer cells
by 3,3-diindolylmethane is associated
with induction and nuclear localization
of p27kip. Mol Cancer Ther. 2008
Feb;7(2):341–9 (hereafter referred to as
‘‘Mol Cancer Ther. 2008’’).
• Down-regulation of platelet-derived
growth factor-D inhibits cell growth and
angiogenesis through inactivation of
Notch-1 and nuclear factor-kB signaling.
Cancer Res. 2007 Dec 1; 67(23):11377–
85 (hereafter referred to as ‘‘Cancer Res.
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Notices]
[Pages 48708-48709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17635]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Health
Workforce Connector, OMB No. 0906-0031--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 13,
2020.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 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
information, please include the information request collection title
for reference.
Information Collection Request Title: Health Workforce Connector,
OMB No. 0906-0031--Extension.
Abstract: More than just a job search portal, the goal of the
Health Workforce Connector is to help connect skilled professionals to
communities in need by allowing approved Site Points of Contact (POCs),
including National Health Service Corps (NHSC) and Nurse Corps, to post
available opportunities and update site profiles. The Health Workforce
Connector provides a central platform to connect participants,
including those in both the NHSC and Nurse Corps programs, and
facilities that are approved for performance of their NHSC or Nurse
Corps service obligation. The Health Workforce Connector has become a
resource that engages any health care professional or student
interested in providing primary care services in underserved
communities and with facilities in need of health care providers. The
Health Workforce Connector also allows users to create a profile,
search for NHSC and Nurse Corps sites, find job and training
opportunities, search for other clinicians who are similarly interested
in working with underserved populations, and be searchable by Site
POCs. Individuals can use the Health Workforce Connector's search
capability with Google Maps.
Need and Proposed Use of the Information: Information will be
collected from users in the following two ways:
(1) Account Creation: Creating an account is optional, but to
create an account the user will be required to enter their first name,
last name, and email address. Those are the only mandatory fields in
the profile account creation process and will be used to send an
automated email allowing the user to validate their login credentials.
This information will also be used to validate any users who already
exist within the Bureau of Health Workforce Management Information
Systems Solution (BMISS) database and allow an initial import of
existing data at the request of the user.
(2) Profile Completion: Users may fill out a profile, but this
function will be completely optional and will include fields such as
location, discipline, specialty, and languages spoken. The information
collected, if `published' by the user, will allow internal BMISS Site
POCs to search for anyone who may be a potential candidate for job
opportunities at the site. Users also have the ability to make their
profiles searchable by other end users through a security and privacy
setting and can make their profiles private at any time. All
information collected will be stored within existing secure BMISS
databases and will be used internally for report generation on an as-
needed basis.
Likely Respondents: Potential users will include individuals
searching for a health care job opportunity or an NHSC or Nurse Corps
health care facility, and
[[Page 48709]]
health care facilities searching for potential candidates to fill open
health care job opportunities at their sites.
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.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Account Creation................ 15,600 1 15,600 .08 1,248
Complete Profile................ 9,400 1 9,400 1 9,400
-------------------------------------------------------------------------------
Total....................... \1\ 15,600 .............. 15,600 .............. 10,648
----------------------------------------------------------------------------------------------------------------
\1\ The 9,400 respondents who complete their profiles are a subset of the 15,600 respondents who create
accounts.
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, Executive Secretariat.
[FR Doc. 2020-17635 Filed 8-11-20; 8:45 am]
BILLING CODE 4165-15-P
