Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 67368-67369 [2013-27006]

Download as PDF 67368 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 .......................... emcdonald on DSK67QTVN1PROD with NOTICES Grantee .......................... Total ........................ VerDate Mar<15>2010 17:41 Nov 08, 2013 Jkt 232001 PO 00000 Frm 00038 Number of respondent Number responses per respondent Type of respondent Fmt 4703 Sfmt 4703 E:\FR\FM\12NON1.SGM 12NON1 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]]

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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