Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 67368-67369 [2013-27006]
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Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices
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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(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
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to
OIRA_submission@omb.eop.gov 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 the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Information Collection Request Title:
Advanced Education Nursing
Traineeship (AENT) Program
Application.
OMB No.: 0915–xxxx—NEW
Abstract: The Health Resources and
Services Administration (HRSA)
provides advanced education nursing
training grants to educational
institutions to increase the numbers of
advanced education nurses through the
AENT Program. The AENT Program is
governed by Title VIII, Section 811(a)(2)
of the Public Health Service Act (42
U.S.C. 296j(a)(2)). This new request
includes the Program Specific AENT
Tables. The proposed AENT Tables will
include data on the distribution of
graduates from the organization who are
working in rural, underserved, and
public health settings, as well as the
distribution of graduates who received
traineeship support and are working in
rural, underserved, and public health
settings; and the number of projected
students to receive traineeship support
by their enrollment status (full-time or
part-time), the degree program (master’s,
post-nursing master’s certificate, or
doctoral), and the specialty in which
they are enrolled (nurse practitioner or
nurse midwifery) by budget year one
and by budget year two.
Need and Proposed Use of the
Information: HRSA will use this
information gathered from the tables in
determining the amount of traineeship
support to be awarded per student, per
institution, and to succinctly capture
data for the number of projected
students for determining eligibility for
Special Consideration and Statutory
Funding Preference.
Likely Respondents: Eligible
applicants are schools of nursing,
nursing centers, academic health
centers, state or local governments, and
other public or private nonprofit entities
determined appropriate by the Secretary
that submit an application and are
accredited for the provision of primary
care nurse practitioner and nurse
midwifery programs accredited by a
national nurse education accrediting
agency recognized by the Secretary of
the U.S. Department of Education. The
school must be located in the 50 states,
the District of Columbia, the
Commonwealth of Puerto Rico, the
Northern Mariana Islands, American
Samoa, Guam, the U.S. Virgin Islands,
the Federated States of Micronesia, the
Republic of the Marshall Islands, or the
Republic of Palau.
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
burden per
response
(in hours)
Form name
Grantee ..........................
Table 1a: Rural, Underserved, or Public health
Practice Settings: Graduate Data.
Table 1b: Rural, Underserved, or Public health
Practice Settings: Graduates Supported Data.
Table 2a: Number of Projected Master’s Degree
and Post Nursing Master’s Certificate Student
To Receive Traineeship Support by Role
(budget year 1 and budget year 2).
Table 2b: Number of Projected Doctoral (PhD
and/or DNP) Degree Nursing Students To Receive Traineeship Support by Role (budget
year 1 and budget year 2).
70
1
3.19
223.3
70
1
3.19
223.3
70
1
3.11
217.7
70
1
3.11
217.7
..............................................................................
70
........................
........................
882
Grantee ..........................
Grantee ..........................
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Grantee ..........................
Total ........................
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Number of
respondent
Number
responses per
respondent
Type of
respondent
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E:\FR\FM\12NON1.SGM
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Total hour
burden
Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices
Dated: November 4, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–27006 Filed 11–8–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: Addition to the Vaccine
Injury Table to Include All Vaccines
Against Seasonal Influenza
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
Through this notice, the
Secretary of the U.S. Department of
Health and Human Services (the
Secretary) announces that all FDAapproved vaccines against seasonal
influenza are covered under the
National Vaccine Injury Compensation
Program (VICP), which provides a
system of no-fault compensation for
certain individuals who have been
injured by covered childhood vaccines.
Prior to this publication, trivalent
influenza vaccines were included under
Category XIV on the Vaccine Injury
Table (Table) and will continue to be
listed in that category. This notice
serves to include all vaccines against
seasonal influenza (not already covered
under Category XIV) as covered
vaccines under Category XVII of the
Table (new vaccines covered under the
VICP). This notice ensures that
petitioners may file petitions relating to
all vaccines against seasonal influenza
(not already covered under the VICP)
with the VICP even before such vaccines
are added as a separate and distinct
category to the Table through
rulemaking.
SUMMARY:
This notice is effective on
November 12, 2013. As described
below, all vaccines against seasonal
influenza (except trivalent influenza
vaccines, which are already covered
under the VICP) will be covered under
the VICP on November 12, 2013.
FOR FURTHER INFORMATION CONTACT: Vito
Caserta, M.D., M.P.H., Acting Director,
Division of Vaccine Injury
Compensation, Healthcare Systems
Bureau, Health Resources and Services
Administration, Parklawn Building,
Room 11C–26, 5600 Fishers Lane,
Rockville, Maryland 20857; telephone
number (301) 443–5287.
emcdonald on DSK67QTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
17:41 Nov 08, 2013
Jkt 232001
The
statute authorizing the VICP provides
for the inclusion of additional vaccines
in the VICP when they are
recommended by the Centers for Disease
Control and Prevention (CDC) to the
Secretary for routine administration to
children. See section 2114(e)(2) of the
Public Health Service (PHS) Act, 42
U.S.C. 300aa–14(e)(2). Consistent with
section 13632(a)(3) of Public Law 103–
66, the regulations governing the VICP
provide that such vaccines will be
included as covered vaccines in the
Table as of the effective date of an
excise tax to provide funds for the
payment of compensation with respect
to such vaccines (42 CFR 100.3(c)(5)).
By way of background, trivalent
influenza vaccines (meaning they each
contain three vaccine virus strains
which are thought most likely to cause
disease outbreaks during the influenza
season) are routinely given to millions
of individuals in the United States each
year. Trivalent influenza vaccines
include an inactivated (killed) virus
vaccine administered using a syringe as
well as a live, attenuated product
administered in a nasal spray. All
trivalent vaccines have been covered
under the VICP since July 1, 2005. On
April 12, 2005, the Health Resources
and Services Administration (HRSA)
published a notice in the Federal
Register announcing that such vaccines
were covered under the category for
new vaccines on the Table. See 70 FR
19092. Subsequently, the Secretary
engaged in rulemaking to add trivalent
influenza vaccines as a separate
category on the Table (category XIV on
the Table). See 76 FR 36367.
Since that time, quadrivalent
influenza vaccines (meaning that they
contain four vaccine virus strains which
are thought most likely to cause disease
outbreaks during the influenza season)
have been approved by the Food and
Drug Administration (FDA), and such
vaccines are expected to be
administered as an alternative to
trivalent influenza vaccines during the
upcoming and future flu seasons. On
June 25, 2013, Public Law 113–15 was
enacted, extending the applicable excise
tax on trivalent influenza vaccines to
also include any other vaccines against
seasonal influenza. See Public Law 113–
15 (amending 26 U.S.C. § 4132(a)(1)(N)).
The amendment included in Public
Law 113–15 ensures that all FDAapproved seasonal influenza vaccines,
including quadrivalent influenza
vaccines, and other new seasonal
influenza vaccines are covered under
the VICP. Under the regulations
governing the VICP, Category XVII of
the Table specifies that ‘‘[a]ny new
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
67369
vaccine recommended by CDC for
routine administration to children, after
publication by the Secretary of a notice
of coverage’’ is a covered vaccine under
the Table (42 CFR 100.3(a), Item XVII).
As explained in HRSA’s notice of
coverage with respect to the coverage of
trivalent influenza vaccines, the CDC
recommended in its May 28, 2004, issue
of the Morbidity and Mortality Weekly
Report (MMWR) that influenza vaccines
be routinely administered to children
between 6 and 23 months of age because
children in this age group are at an
increased risk for complications from
influenza. That recommendation
extends to seasonal influenza vaccines
beyond trivalent vaccines. The latest
CDC update of its annual influenza
vaccination recommendation was
published in the MMWR on September
20, 2013. MMWR 2013;62, No. 7. This
report updated the 2012
recommendations by the CDC and its
Advisory Committee on Immunization
Practices regarding the use of influenza
vaccines for the prevention and control
of seasonal influenza. Routine annual
influenza vaccination is recommended
for all persons aged 6 months and older.
For the 2013–14 influenza season, it is
expected that trivalent live attenuated
influenza vaccine (LAIV3) will be
replaced by a quadrivalent LAIV
formulation (LAIV4). Inactivated
influenza vaccines (IIVs) will be
available in both trivalent (IIV3) and
quadrivalent (IIV4) formulations. No
preferential recommendation was made
for one influenza vaccine product over
another for persons for whom more than
one product is otherwise appropriate.
This notice serves to satisfy the
regulation’s publication requirement.
Through this notice, all vaccines against
seasonal influenza (beyond trivalent
influenza vaccines, which are already
covered under Category XIV on the
Table) are included as covered vaccines
under Category XVII of the Table (new
vaccines).
Under section 2114(e) of the PHS Act,
as amended by section 13632(a) of the
Omnibus Budget Reconciliation Act of
1993, coverage for a vaccine
recommended by the CDC for routine
administration to children shall take
effect upon the effective date of the tax
enacted to provide funds for
compensation with respect to the
vaccine included as a covered vaccine
in the Table. Under Public Law 113–15,
the excise tax for vaccines against
seasonal influenza (beyond trivalent
influenza vaccines) ‘‘shall apply to sales
and uses on or after the later of: (A) The
first day of the first month which begins
more than 4 weeks after the date of the
enactment of this Act [i.e., Pub. L. 113–
E:\FR\FM\12NON1.SGM
12NON1
]]>Agencies
[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67368-67369]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27006]
[[Page 67368]]
-----------------------------------------------------------------------
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
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(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 the public during the
review and approval period.
DATES: Comments on this ICR should be received within 30 days of this
notice.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 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 the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Advanced Education Nursing
Traineeship (AENT) Program Application.
OMB No.: 0915-xxxx--NEW
Abstract: The Health Resources and Services Administration (HRSA)
provides advanced education nursing training grants to educational
institutions to increase the numbers of advanced education nurses
through the AENT Program. The AENT Program is governed by Title VIII,
Section 811(a)(2) of the Public Health Service Act (42 U.S.C.
296j(a)(2)). This new request includes the Program Specific AENT
Tables. The proposed AENT Tables will include data on the distribution
of graduates from the organization who are working in rural,
underserved, and public health settings, as well as the distribution of
graduates who received traineeship support and are working in rural,
underserved, and public health settings; and the number of projected
students to receive traineeship support by their enrollment status
(full-time or part-time), the degree program (master's, post-nursing
master's certificate, or doctoral), and the specialty in which they are
enrolled (nurse practitioner or nurse midwifery) by budget year one and
by budget year two.
Need and Proposed Use of the Information: HRSA will use this
information gathered from the tables in determining the amount of
traineeship support to be awarded per student, per institution, and to
succinctly capture data for the number of projected students for
determining eligibility for Special Consideration and Statutory Funding
Preference.
Likely Respondents: Eligible applicants are schools of nursing,
nursing centers, academic health centers, state or local governments,
and other public or private nonprofit entities determined appropriate
by the Secretary that submit an application and are accredited for the
provision of primary care nurse practitioner and nurse midwifery
programs accredited by a national nurse education accrediting agency
recognized by the Secretary of the U.S. Department of Education. The
school must be located in the 50 states, the District of Columbia, the
Commonwealth of Puerto Rico, the Northern Mariana Islands, American
Samoa, Guam, the U.S. Virgin Islands, the Federated States of
Micronesia, the Republic of the Marshall Islands, or the Republic of
Palau.
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 burden per Total hour
Type of respondent Form name respondent responses per response (in burden
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grantee........................................ Table 1a: Rural, Underserved, or Public 70 1 3.19 223.3
health Practice Settings: Graduate
Data.
Grantee........................................ Table 1b: Rural, Underserved, or Public 70 1 3.19 223.3
health Practice Settings: Graduates
Supported Data.
Grantee........................................ Table 2a: Number of Projected Master's 70 1 3.11 217.7
Degree and Post Nursing Master's
Certificate Student To Receive
Traineeship Support by Role (budget
year 1 and budget year 2).
Grantee........................................ Table 2b: Number of Projected Doctoral 70 1 3.11 217.7
(PhD and/or DNP) Degree Nursing
Students To Receive Traineeship
Support by Role (budget year 1 and
budget year 2).
--------------------------------------------------------------------------------------------------------
Total...................................... ....................................... 70 .............. .............. 882
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 67369]]
Dated: November 4, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-27006 Filed 11-8-13; 8:45 am]
BILLING CODE 4165-15-P
