Submission for OMB Review; 30-Day Comment Request: Application Process for Clinical Research Training and Medical Education at the NIH Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness (Clinical Center), 23010-23012 [2017-10205]

Download as PDF 23010 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices Estimated Total Annual Burden Hours: 15,114. In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2017–10150 Filed 5–18–17; 8:45 am] BILLING CODE 4184–40–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Community Services Block Grant (CSBG) Model State Plan (Revision). OMB No.: 0970–0382. Description: Section 676 of the Community Services Block Grant (CSBG) Act requires States, including the District of Columbia and the Commonwealth of Puerto Rico, and U.S. territories applying for CSBG funds to submit an application and plan (Model State Plan). The CSBG State Plan submitted by States must meet statutory requirements prior to being funded with CSBG funds. Applicants have the option to submit a detailed plan annually or biannually. Entities that submit a biannual plan must provide an abbreviated plan the following year if substantial changes to the initial plan will occur. In 2015, the Model State Plan was substantially revised by automating the form, streamlining the information, and incorporating accountability measures that include customer satisfaction information from eligible entities that receive a proportional share of CSBG funding through State CSBG lead agencies along with technical assistance, monitoring, and other programmatic support. In fall 2015, the Office of Community Services (OCS) used the American Customer Satisfaction Index (ACSI) to obtain feedback from CSBG eligible entities about services provided by the state CSBG Lead Agencies, as detailed in the new State Accountability Measures. OCS also obtained feedback from state CSBG Lead Agencies on services provided by the federal agency, as outlined in the new Federal Accountability Measures. Both OCS and state CSBG Directors received their state survey results in February 2016. To support ongoing implementation of state accountability measures related to customer satisfaction from eligible entities, OCS plans to survey eligible entities using the ACSI survey instrument. No changes are planned from the content of the 2015 survey. Respondents: CSBG eligible entities. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours ACSI CSBG Eligible Entity Survey .................................................................. asabaliauskas on DSK3SPTVN1PROD with NOTICES Instrument 1035 1 .5 517.5 Estimated Total Annual Burden Hours: 517.5. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2017–10209 Filed 5–18–17; 8:45 am] BILLING CODE 4184–27–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Application Process for Clinical Research Training and Medical Education at the NIH Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness (Clinical Center) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information SUMMARY: Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 23011 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices collection listed below. This proposed information collection was previously published in the Federal Register on March 9, 2017, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Robert M. Lembo, Deputy Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center, ADDRESSES: application process is to allow the Office of Clinical Research Training and Medical Education (OCRTME) at the NIH Clinical Center to evaluate applicants’ qualifications to determine applicants’ eligibility for courses and training programs managed by the Office. Applicants must provide the required information requested in the respective applications to be considered a candidate for participation. Information submitted by candidates for training programs is reviewed initially by OCRTME administrative staff to establish eligibility for participation. Eligible candidates are then referred to the designated training program director/administrator or training program selection committee for review and decisions regarding acceptance for participation. A secondary objective of the application process is to track enrollment in courses and training programs over time. Building 10, Room 1N252, MSC–1158, Bethesda, Maryland, 20892 or call nontoll-free number (301) 594–4193 or Email your request, including your address to: Robert.Lembo@nih.gov. SUPPLEMENTARY INFORMATION: The NIH Clinical Center (CC), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Application Process for Clinical Research Training and Medical Education at the NIH Clinical Center, Revision OMB #0925– 0698, Expiration date May 31, 2017, National Institutes of Health Clinical Center (CC), National Institutes of Health (NIH). Need and Use of Information Collection: The primary objective of the OMB approval is requested for 3 years. There is no cost to respondents other than their time. There are capital, operating, and/or maintenance costs of $64,448. The total estimated annualized burden hours are 4,148. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents per year Average burden per response (in hours) Number of responses per respondent Total annual burden hours Type of respondents Form name Pre-Doctoral (MD, DDS, DVM, PhD) Students, Post-Doctoral Students, Physicians/Surgeons, Other Health Care Practitioners/Technicians. MRSP ................................... 140 1 20/60 47 IPPCR ................................... NIH-Duke .............................. PCP ...................................... PhD Summer Course ........... Sabbatical ............................. GME ...................................... 6700 16 800 70 10 2500 1 1 1 1 1 1 20/60 20/60 20/60 20/60 20/60 20/60 2233 5 267 23 3 833 CEP ...................................... REP ...................................... Bioethics ............................... Clinical Research Course ..... 300 90 262 1560 1 1 1 1 20/60 20/60 20/60 20/60 100 30 87 520 ............................................... 12,448 ........................ ........................ 4148 Pre-Doctoral (MD, DDS, DVM, PhD) Students, Post-Doctoral Students, Physicians/Surgeons, Other Health Care Practitioners/Technicians. asabaliauskas on DSK3SPTVN1PROD with NOTICES Totals ..................................................... Dated: May 9, 2017. Laura M. Lee, Project Clearance Liaison, NIH Clinical Center, National Institutes of Health. [FR Doc. 2017–10205 Filed 5–18–17; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 20:24 May 18, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 23012 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Chimeric L1/L2 Protein and Virus-Like Particles Based Human Papillomavirus Vaccines National Institutes of Health, Department of Health and Human Services. ACTION: Notice. AGENCY: The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to PathoVax, LLC located in Baltimore, MD. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before June 5, 2017 will be considered. SUMMARY: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Kevin W. Chang, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702 Telephone: (240)-276–6910; Facsimile: (240)-276–5504 Email: changke@mail.nih.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: asabaliauskas on DSK3SPTVN1PROD with NOTICES Intellectual Property United States Provisional Patent Application No. 60/649,249 filed February 1, 2005 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Reference No. E–103–2005/0–US–01]; United States Provisional Patent Application No. 60/697,655 filed July 7, 2005 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies’’ [HHS Reference No. E– 103–2005/1–US–01]; United States Provisional Patent Application No. 60/ 752,268 filed December 21, 2005 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly VerDate Sep<11>2014 20:24 May 18, 2017 Jkt 241001 Cross-neutralizing Antibodies’’ [HHS Reference No. E–103–2005/2–US–01]; International PCT Application No. PCT/ US2006/003601 filed February 1, 2006, and entitled, ‘‘Papillomavirus L2 Nterminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies’’ [HHS Reference No. E–103–2005/3– PCT–01]; United States Patent No. 8,404,244, issued March 26, 2013 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–US–02]; United States Patent No. 9,388,221 issued July 12, 2016 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies’’ [HHS Ref. No. E–103–2005/ 3–US–10]; Canadian Patent Application No. 2,596,698 filed February 1, 2006 and entitled, ‘‘Papillomavirus L2 Nterminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–CA–03]; Australian Patent No. 2006210792 issued November 8, 2012 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–AU–04]; Japanese Patent No. 5224821 issued March 22, 2013 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–JP–05]; Brazilian Patent Application No. PI0607097–3 filed February 1, 2006 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–BR–06]; Chinese Patent No. 200680011079.1 issued March 27, 2013 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–CN–07]; Indian Patent No. 263255 issued October 16, 2014 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–IN–08]; European Patent No. 1853307 issued December 14, 2016 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–EP–09]; German Patent No. 1853307 issued December 14, 2016 and entitled, ‘‘Papillomavirus L2 Nterminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–DE–11]; French Patent No. 1853307 issued PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 December 14, 2016 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–FR–12]; and United Kingdom Patent No. 1853307 issued December 14, 2016 and entitled, ‘‘Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–GB–13]. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘Use of Human Papillomavirus Virus (HPV) L1/L2 chimeric proteins and Virus Like Particles (VLPs) for the prevention and/ or treatment of cutaneous, mucosal HPV infections and diseases.’’ The subject technologies are papillomavirus L2 capsid protein based vaccines against HPV. The L2 protein is the minor papillomavirus capsid protein for papillomaviruses. It is known that antibodies to this protein can neutralize homologous infection. Furthermore, L2 proteins can induce cross-neutralizing antibodies. Specifically, epitopes at the N-terminus of L2 shared by cutaneous and mucosal types of papillomavirus types and by types that infect divergent species are broadly cross-neutralizing. These epitopes at the N-terminus of L2 can be used to elicit cross-neutralizing antibodies against different types of HPV. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23010-23012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10205]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request: Application 
Process for Clinical Research Training and Medical Education at the NIH 
Clinical Center and Its Impact on Course and Training Program 
Enrollment and Effectiveness (Clinical Center)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information

[[Page 23011]]

collection listed below. This proposed information collection was 
previously published in the Federal Register on March 9, 2017, and 
allowed 60 days for public comment. No public comments were received. 
The purpose of this notice is to allow an additional 30 days for public 
comment.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: Written comments and/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Dr. Robert M. Lembo, Deputy Director, Office of 
Clinical Research Training and Medical Education, NIH Clinical Center, 
Building 10, Room 1N252, MSC-1158, Bethesda, Maryland, 20892 or call 
non-toll-free number (301) 594-4193 or Email your request, including 
your address to: Robert.Lembo@nih.gov.

SUPPLEMENTARY INFORMATION: The NIH Clinical Center (CC), National 
Institutes of Health, may not conduct or sponsor, and the respondent is 
not required to respond to, an information collection that has been 
extended, revised, or implemented on or after October 1, 1995, unless 
it displays a currently valid OMB control number.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health (NIH) has submitted to 
the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below.
    Proposed Collection: Application Process for Clinical Research 
Training and Medical Education at the NIH Clinical Center, Revision OMB 
#0925-0698, Expiration date May 31, 2017, National Institutes of Health 
Clinical Center (CC), National Institutes of Health (NIH).
    Need and Use of Information Collection: The primary objective of 
the application process is to allow the Office of Clinical Research 
Training and Medical Education (OCRTME) at the NIH Clinical Center to 
evaluate applicants' qualifications to determine applicants' 
eligibility for courses and training programs managed by the Office. 
Applicants must provide the required information requested in the 
respective applications to be considered a candidate for participation. 
Information submitted by candidates for training programs is reviewed 
initially by OCRTME administrative staff to establish eligibility for 
participation. Eligible candidates are then referred to the designated 
training program director/administrator or training program selection 
committee for review and decisions regarding acceptance for 
participation. A secondary objective of the application process is to 
track enrollment in courses and training programs over time.
    OMB approval is requested for 3 years. There is no cost to 
respondents other than their time. There are capital, operating, and/or 
maintenance costs of $64,448. The total estimated annualized burden 
hours are 4,148.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of       Number of    Average burden
           Type of respondents                               Form name                      respondents    responses per   per response    Total annual
                                                                                             per year       respondent      (in hours)     burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-Doctoral (MD, DDS, DVM, PhD)          MRSP..........................................             140               1           20/60              47
 Students, Post-Doctoral Students,
 Physicians/Surgeons, Other Health Care
 Practitioners/Technicians.
                                          IPPCR.........................................            6700               1           20/60            2233
                                          NIH-Duke......................................              16               1           20/60               5
                                          PCP...........................................             800               1           20/60             267
                                          PhD Summer Course.............................              70               1           20/60              23
                                          Sabbatical....................................              10               1           20/60               3
Pre-Doctoral (MD, DDS, DVM, PhD)          GME...........................................            2500               1           20/60             833
 Students, Post-Doctoral Students,
 Physicians/Surgeons, Other Health Care
 Practitioners/Technicians.
                                          CEP...........................................             300               1           20/60             100
                                          REP...........................................              90               1           20/60              30
                                          Bioethics.....................................             262               1           20/60              87
                                          Clinical Research Course......................            1560               1           20/60             520
                                                                                         ---------------------------------------------------------------
    Totals..............................  ..............................................          12,448  ..............  ..............            4148
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: May 9, 2017.
Laura M. Lee,
Project Clearance Liaison, NIH Clinical Center, National Institutes of 
Health.
[FR Doc. 2017-10205 Filed 5-18-17; 8:45 am]
 BILLING CODE 4140-01-P