Agency Information Collection Activities: Proposed Collection: Public Comment Request, 6732-6733 [2015-02314]
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Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices
Pharmaceutical companies may
submit proposed agendas to the Agency
by April 7, 2015.
FOR FURTHER INFORMATION CONTACT: Dan
Brum, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5480, Silver Spring,
MD 20993–0002, 301–796–0578,
dan.brum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
primary goal, CDER has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) Firsthand exposure to
industry’s drug development processes,
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
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management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
III. Site Selection
All travel expenses associated with
the Site Tours Program will be the
responsibility of CDER; therefore,
selection will be based on the
availability of funds and resources for
each fiscal year. Selection will also be
based on firms having a favorable
facility status as determined by FDA’s
Office of Regulatory Affairs District
Offices in the firms’ respective regions.
Firms interested in offering a site tour
or learning more about this training
opportunity should respond by
submitting a proposed agenda to Dan
Brum (see DATES and FOR FURTHER
INFORMATION CONTACT).
Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02426 Filed 2–5–15; 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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (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 Information
Collection Request must be received no
later than April 7, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10C–03, Parklawn
SUMMARY:
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Building, 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 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:
Nurse Corps Scholarship Program, OMB
No. 0915–0301—Revision.
Abstract: The Nurse Corps
Scholarship Program (Nurse Corps SP)
is a competitive Federal program, which
awards scholarships to individuals for
attendance at accredited schools of
nursing. The Bureau of Health
Workforce (BHW) in HRSA administers
the program. The scholarship consists of
payment of tuition, fees, other
reasonable educational costs, and a
monthly support stipend. In return, the
students agree to provide a minimum of
2 years of full-time clinical service (or
an equivalent part-time commitment, as
approved by the Nurse Corps SP) at a
health care facility with a critical
shortage of nurses as defined by the
program. Nurse Corps SP recipients
must be willing to (and are required to)
fulfill their Nurse Corps SP service
commitment at a health care facility
with a critical shortage of nurses in the
United States, which includes, in
addition to the several states, only: The
District of Columbia, Guam, the
Commonwealth of Puerto Rico, the
Northern Mariana Islands, the U.S.
Virgin Islands, American Samoa, the
Federated States of Micronesia, the
Republic of the Marshall Islands, and
the Republic of Palau.
Students who are uncertain of their
commitment to provide nursing care in
a health care facility with a critical
shortage of nurses in the United States
or these territories are advised not to
participate in the program.
Need and Proposed Use of the
Information: The Nurse Corps
Scholarship Program needs to collect
data to determine an applicant’s
eligibility for the program, to monitor a
participant’s continued enrollment in a
school of nursing, to monitor the
participant’s compliance with the Nurse
Corps Scholarship Program service
obligation, and to obtain data on its
program to ensure compliance with
statutory mandates and prepare annual
reports to Congress. The following
information will be collected: (1) From
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06FEN1
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Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices
the applicants and/or the schools—
general applicant and nursing school
data such as full name, location, tuition/
fees, and enrollment status; (2) from the
schools, on an annual basis—data
concerning tuition/fees and student
enrollment status; and (3) from the
participants and their health care
facilities with a critical shortage of
nurses, on a biannual basis—data
concerning the participant’s
employment status, work schedule and
leave usage. BHW enters the cost
information into its data system, along
with the projected amount for the
monthly stipend, to determine the
amount of each scholarship award.
Likely Respondents: Nurse Corps
Scholarship Program scholars in school
and graduates.
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
Number of
respondents
Form name
Number of
responses per
respondent
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 Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Eligible Applications .............................................................
In-School Monitoring ............................................................
In-Service Monitoring ...........................................................
2,600
500
500
1
2
2
2,600
1,000
1,000
2
2
1
5,200
2,000
1,000
Total ..............................................................................
3,600
........................
4,600
........................
8,200
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.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–02314 Filed 2–5–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of Dietary Supplements 2015–
2020 Strategic Plan Request for
Comments
The Office of Dietary
Supplements (ODS) at the National
Institutes of Health (NIH) has initiated
a strategic planning process that will
culminate in the ODS Strategic Plan for
2015–2020. To assist with this process,
the ODS requests input from research
communities—academic, government,
and industry—and from other interested
parties.
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SUMMARY:
In order to ensure full
consideration, all responses must be
submitted by midnight, March 6, 2015.
DATES:
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ADDRESSES:
Interested individuals and
organizations should submit their
responses to ODSplan@od.nih.gov.
Dated: January 30, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–02370 Filed 2–5–15; 8:45 am]
Anne L. Thurn, Ph.D., Office of Dietary
Supplements, National Institutes of
Health, 6100 Executive Boulevard,
Room 3B01, Bethesda, MD 20892–7517,
Phone: 301–435–2920, Fax: 301–480–
1845, Email: ODSplan@od.nih.gov.
BILLING CODE 4140–01–P
The
overall purpose of the strategic planning
effort is to identify both new
opportunities and emerging needs for
incorporation in the programmatic
efforts of the Office. A background
paper, ODS Strategic Plan 2010–2014
Progress Report, summarizes progress in
five key areas of ODS activities. The
background paper and related
information are available on the ODS
Web site at https://ods.od.nih.gov/
strategicplan.
Guidance is being requested from all
interested parties on these important
issues.
• Are the current strategic goals
adequate?
• Is ODS meeting its stakeholders’
needs?
• In the future, should some of ODS’s
current programs or activities be given
higher (or lower) priority?
• How can ODS more effectively
provide useful information to the ODS
user community, including consumers,
investigators, practitioners, industry,
media, policy makers, government, and
other interested parties?
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2014–0973; OMB Control Number
1625–0077]
Collection of Information Under
Review by Office of Management and
Budget
Coast Guard, DHS.
Thirty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding
Information Collection Requests (ICRs),
abstracted below, to the Office of
Management and Budget (OMB), Office
of Information and Regulatory Affairs
(OIRA), requesting approval of an
extension of a currently approved
collection of information: 1625–0077,
Security Plans for Ports, Vessels,
Facilities, Outer Continental Shelf
Facilities and Other Security-Related
Requirements. Review and comments by
OIRA ensure we only impose paperwork
burdens commensurate with our
performance of duties.
DATES: Comments must reach the Coast
Guard and OIRA on or before April 7,
2015.
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 25 (Friday, February 6, 2015)]
[Notices]
[Pages 6732-6733]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02314]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (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 Information Collection Request must be received
no later than April 7, 2015.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10C-03, Parklawn
Building, 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 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: Nurse Corps Scholarship
Program, OMB No. 0915-0301--Revision.
Abstract: The Nurse Corps Scholarship Program (Nurse Corps SP) is a
competitive Federal program, which awards scholarships to individuals
for attendance at accredited schools of nursing. The Bureau of Health
Workforce (BHW) in HRSA administers the program. The scholarship
consists of payment of tuition, fees, other reasonable educational
costs, and a monthly support stipend. In return, the students agree to
provide a minimum of 2 years of full-time clinical service (or an
equivalent part-time commitment, as approved by the Nurse Corps SP) at
a health care facility with a critical shortage of nurses as defined by
the program. Nurse Corps SP recipients must be willing to (and are
required to) fulfill their Nurse Corps SP service commitment at a
health care facility with a critical shortage of nurses in the United
States, which includes, in addition to the several states, only: The
District of Columbia, Guam, the Commonwealth of Puerto Rico, the
Northern Mariana Islands, the U.S. Virgin Islands, American Samoa, the
Federated States of Micronesia, the Republic of the Marshall Islands,
and the Republic of Palau.
Students who are uncertain of their commitment to provide nursing
care in a health care facility with a critical shortage of nurses in
the United States or these territories are advised not to participate
in the program.
Need and Proposed Use of the Information: The Nurse Corps
Scholarship Program needs to collect data to determine an applicant's
eligibility for the program, to monitor a participant's continued
enrollment in a school of nursing, to monitor the participant's
compliance with the Nurse Corps Scholarship Program service obligation,
and to obtain data on its program to ensure compliance with statutory
mandates and prepare annual reports to Congress. The following
information will be collected: (1) From
[[Page 6733]]
the applicants and/or the schools--general applicant and nursing school
data such as full name, location, tuition/fees, and enrollment status;
(2) from the schools, on an annual basis--data concerning tuition/fees
and student enrollment status; and (3) from the participants and their
health care facilities with a critical shortage of nurses, on a
biannual basis--data concerning the participant's employment status,
work schedule and leave usage. BHW enters the cost information into its
data system, along with the projected amount for the monthly stipend,
to determine the amount of each scholarship award.
Likely Respondents: Nurse Corps Scholarship Program scholars in
school and graduates.
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 Information Collection Request 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
----------------------------------------------------------------------------------------------------------------
Eligible Applications........... 2,600 1 2,600 2 5,200
In-School Monitoring............ 500 2 1,000 2 2,000
In-Service Monitoring........... 500 2 1,000 1 1,000
-------------------------------------------------------------------------------
Total....................... 3,600 .............. 4,600 .............. 8,200
----------------------------------------------------------------------------------------------------------------
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.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-02314 Filed 2-5-15; 8:45 am]
BILLING CODE 4165-15-P
