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 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. Approval is withdrawn as of June 11, 2020.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 Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 11, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table.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