Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Nurse Faculty Loan Program-Program Specific Data Form and Annual Performance Report Financial Data Form OMB No. 0915-0314-Revision, 28017-28018 [2020-10134]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
applicants notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
Approval is withdrawn as of
June 11, 2020.
DATES:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
Application No.
Drug
Applicant
ANDA 065232 ......................
Ceftriaxone Sodium for Injection, Equivalent to (EQ) 10
grams (g) base/vial.
Amitriptyline Hydrochloride (HCl) Tablets, 10 milligrams
(mg).
Amitriptyline HCl Tablets, 25 mg ....................................
Amitriptyline HCl Tablets, 50 mg ....................................
Amitriptyline HCl Tablets, 75 mg ....................................
Amitriptyline HCl Tablets, 100 mg ..................................
Amitriptyline HCl Tablets, 150 mg ..................................
Hospira Inc., 275 North Field Dr., Building H1, Lake
Forest, IL 60045.
Par Pharmaceutical Inc., One Ram Ridge Rd., Spring
Valley, NY 10977.
Par Pharmaceutical Inc.
Do.
Do.
Do.
Do.
ANDA 088697 ......................
ANDA
ANDA
ANDA
ANDA
ANDA
088698
088699
088700
088701
088702
......................
......................
......................
......................
......................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of June 11, 2020.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
from the table. Introduction or delivery
for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in the table that
are in inventory on June 11, 2020, may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10082 Filed 5–11–20; 8:45 am]
BILLING CODE 4164–01–P
jbell on DSKJLSW7X2PROD with NOTICES
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
28017
VerDate Sep<11>2014
18:47 May 11, 2020
Jkt 250001
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; Nurse Faculty Loan
Program—Program Specific Data Form
and Annual Performance Report
Financial Data Form OMB No. 0915–
0314–Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
SUMMARY: In compliance with 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 have been 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.
DATES: Comments on this ICR should be
received no later than June 11, 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Public Comments’’ or by using the
search function.
To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Nurse Faculty Loan Program—Program
Specific Data Form and Annual
Performance Report Financial Data
Form OMB No. 0915–0314–Revision.
Abstract: This clearance request is for
approval of both the Nurse Faculty Loan
Program (NFLP) Program Specific Data
Form and the Annual Performance
Report (APR) Financial Data Form. The
APR Financial Data Form is currently
approved under OMB Approval No.
0915–0314 and the Program Specific
Data Form is currently approved under
OMB Approval No. 0915–0378, both
with the expiration date of July 31,
2020. The APR Form was previously
titled as the Nurse Faculty Loan
Program, Annual Operating Report. For
program efficiency, HRSA is combining
these previously separate ICRs under
OMB No. 0915–0314 and will be
discontinuing OMB No. 0915–0378.
A 60-day notice published in the
Federal Register on February 7, 2020,
vol. 85, No. 26; pp. 7315–7316. There
were no public comments.
Need and Proposed Use of the
Information: Section 846A of the Public
Health Service Act provides the
Secretary of HHS with the authority to
enter into an agreement with schools of
nursing for the establishment and
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\12MYN1.SGM
12MYN1
28018
Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
operation of a student loan fund to
increase the number of qualified nurse
faculty.
Under the agreement, HRSA makes
awards to the school for the NFLP loan
fund, which must be maintained in a
distinct account. The school of nursing
makes loans from the NFLP account to
students enrolled full-time or, at the
discretion of the Secretary, part-time, in
a master’s or doctoral nursing education
program that will prepare them to
become qualified nursing faculty.
Following graduation from the NFLP
lending school, loan recipients may
receive up to 85 percent NFLP loan
cancellation over a four-year period in
exchange for service as full-time faculty
at a school of nursing. The NFLP
lending school collects any portion of
the loan that is not cancelled and any
loans that go into repayment due to
default, and deposits these monies into
the NFLP loan fund to make additional
NFLP loans.
The NFLP—Program Specific Data
Form is a required electronic attachment
within the NFLP application materials.
The data provided in the form is
essential for the formula-based criteria
used to determine the award amount to
the applicant schools. The form will
collect application related data from
applicants such as the amount
requested, number of students to be
funded, tuition information, and
projected unused loan fund balance.
Approval of the NFLP—Program
Specific Data Form will allow HRSA to
continue to efficiently capture data to
generate the formula-based awards for
the NFLP program. This data collection
assists HRSA in streamlining the
application submission process,
enabling an efficient award
determination process, and facilitating
reporting on the use of funds and
analysis of program outcomes.
HRSA is also seeking public comment
on the NFLP–APR Financial Data Form.
The NFLP–APR Financial Data Form is
an online form that exists in the HRSA
Electronic Handbooks (EHBs)
Performance Report module. The NFLP–
APR Financial Data Form will collect
outcome and financial data to capture
the NFLP loan fund account activity
related to financial receivables,
disbursements, and borrower account
data related to employment status, loan
cancellation, loan repayment and
collections. Participating schools will
provide HHS with current and
cumulative information on: (1) NFLP
loan funds received, (2) number and
amount of NFLP loans made, (3) number
and amount of loans cancelled, (4)
number and amount of loans in
repayment, (5) loan default rate percent,
(6) number of NFLP graduates employed
as nurse faculty, and (7) other related
loan fund costs and activities.
The school of nursing must keep
records of all NFLP loan fund
transactions. The NFLP–APR Financial
Data Form is used to monitor grantee
performance by collecting information
related to the NFLP loan fund
operations and financial activities for a
specified reporting period (July 1
through June 30 of the academic year).
Participating schools are required to
complete and submit the NFLP–APR
Financial Data Form annually.
The data provided in the form is
essential for HRSA to effectively
monitor the school’s use of NFLP funds
in accordance with the statute and
program guidelines. Approval of the
NFLP–APR Financial Data Form
extension will allow HRSA to continue
to monitor program performance and
program outcome.
Likely Respondents: Participating
NFLP schools and applicants to the
NFLP 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.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
respondents per
respondent
Total burden
hours
Nurse Faculty Loan Program—Program Specific Data
Form .............................................................................
Nurse Faculty Loan Program—Annual Performance Report Financial Data Form .............................................
90
1
90
8
720
260
1
260
6
1,560
Total Burden ....................................................................
350
............................
350
........................
2,280
Maria G. Button,
Director, Executive Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2020–10134 Filed 5–11–20; 8:45 am]
BILLING CODE 4165–15–P
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
jbell on DSKJLSW7X2PROD with NOTICES
Average
burden per
response
(in hours)
Total
responses
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
VerDate Sep<11>2014
18:47 May 11, 2020
Jkt 250001
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Vascular and
Hematology Integrated Review Group;
Hemostasis and Thrombosis Study Section.
Date: June 12, 2020.
Time: 8:00 a.m. to 6:00 p.m.
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[Federal Register Volume 85, Number 92 (Tuesday, May 12, 2020)]
[Notices]
[Pages 28017-28018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10134]
-----------------------------------------------------------------------
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; Nurse Faculty Loan
Program--Program Specific Data Form and Annual Performance Report
Financial Data Form OMB No. 0915-0314-Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with 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 have been 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.
DATES: Comments on this ICR should be received no later than June 11,
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.
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: Nurse Faculty Loan Program--
Program Specific Data Form and Annual Performance Report Financial Data
Form OMB No. 0915-0314-Revision.
Abstract: This clearance request is for approval of both the Nurse
Faculty Loan Program (NFLP) Program Specific Data Form and the Annual
Performance Report (APR) Financial Data Form. The APR Financial Data
Form is currently approved under OMB Approval No. 0915-0314 and the
Program Specific Data Form is currently approved under OMB Approval No.
0915-0378, both with the expiration date of July 31, 2020. The APR Form
was previously titled as the Nurse Faculty Loan Program, Annual
Operating Report. For program efficiency, HRSA is combining these
previously separate ICRs under OMB No. 0915-0314 and will be
discontinuing OMB No. 0915-0378.
A 60-day notice published in the Federal Register on February 7,
2020, vol. 85, No. 26; pp. 7315-7316. There were no public comments.
Need and Proposed Use of the Information: Section 846A of the
Public Health Service Act provides the Secretary of HHS with the
authority to enter into an agreement with schools of nursing for the
establishment and
[[Page 28018]]
operation of a student loan fund to increase the number of qualified
nurse faculty.
Under the agreement, HRSA makes awards to the school for the NFLP
loan fund, which must be maintained in a distinct account. The school
of nursing makes loans from the NFLP account to students enrolled full-
time or, at the discretion of the Secretary, part-time, in a master's
or doctoral nursing education program that will prepare them to become
qualified nursing faculty. Following graduation from the NFLP lending
school, loan recipients may receive up to 85 percent NFLP loan
cancellation over a four-year period in exchange for service as full-
time faculty at a school of nursing. The NFLP lending school collects
any portion of the loan that is not cancelled and any loans that go
into repayment due to default, and deposits these monies into the NFLP
loan fund to make additional NFLP loans.
The NFLP--Program Specific Data Form is a required electronic
attachment within the NFLP application materials. The data provided in
the form is essential for the formula-based criteria used to determine
the award amount to the applicant schools. The form will collect
application related data from applicants such as the amount requested,
number of students to be funded, tuition information, and projected
unused loan fund balance. Approval of the NFLP--Program Specific Data
Form will allow HRSA to continue to efficiently capture data to
generate the formula-based awards for the NFLP program. This data
collection assists HRSA in streamlining the application submission
process, enabling an efficient award determination process, and
facilitating reporting on the use of funds and analysis of program
outcomes.
HRSA is also seeking public comment on the NFLP-APR Financial Data
Form. The NFLP-APR Financial Data Form is an online form that exists in
the HRSA Electronic Handbooks (EHBs) Performance Report module. The
NFLP-APR Financial Data Form will collect outcome and financial data to
capture the NFLP loan fund account activity related to financial
receivables, disbursements, and borrower account data related to
employment status, loan cancellation, loan repayment and collections.
Participating schools will provide HHS with current and cumulative
information on: (1) NFLP loan funds received, (2) number and amount of
NFLP loans made, (3) number and amount of loans cancelled, (4) number
and amount of loans in repayment, (5) loan default rate percent, (6)
number of NFLP graduates employed as nurse faculty, and (7) other
related loan fund costs and activities.
The school of nursing must keep records of all NFLP loan fund
transactions. The NFLP-APR Financial Data Form is used to monitor
grantee performance by collecting information related to the NFLP loan
fund operations and financial activities for a specified reporting
period (July 1 through June 30 of the academic year). Participating
schools are required to complete and submit the NFLP-APR Financial Data
Form annually.
The data provided in the form is essential for HRSA to effectively
monitor the school's use of NFLP funds in accordance with the statute
and program guidelines. Approval of the NFLP-APR Financial Data Form
extension will allow HRSA to continue to monitor program performance
and program outcome.
Likely Respondents: Participating NFLP schools and applicants to
the NFLP 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.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents respondents per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Nurse Faculty Loan Program-- 90 1 90 8 720
Program Specific Data Form...
Nurse Faculty Loan Program-- 260 1 260 6 1,560
Annual Performance Report
Financial Data Form..........
---------------------------------------------------------------------------------
Total Burden.................. 350 ................ 350 .............. 2,280
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-10134 Filed 5-11-20; 8:45 am]
BILLING CODE 4165-15-P
