80 FR 15218 - Submission for OMB Review; 30-Day Comment Request Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil (NHLBI)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 55 (March 23, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 55 (March 23, 2015)
| Page Range | 15218-15220 | |
| FR Document | 2015-06565 |
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)] [Notices] [Pages 15218-15220] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06565] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil (NHLBI) SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), 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. This proposed information collection was previously published in the FR in Volume 79 on December 31, 2014 on page 78876 and allowed 60-days for public comment. One public comment was received that was a personal opinion regarding conducting research about the Brazil blood donation system. The purpose of this notice is to allow an additional 30 days for public comment. The 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. Direct Comments To Omb: 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, [email protected] or by fax to 202-395-6974, Attention: Desk Officer for NIH. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge [[Page 15219]] Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301-435-0065, or Email your request, including your address to: [email protected]. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Prevalence, Incidence, Epidemiology and Molecular Variants of HIV, in Blood Donors in Brazil 0925-0597, Expiration Date, July 31, 2015, Extension, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) Need and Use of Information Collection: Establishing and monitoring viral prevalence and incidence rates, and identifying behavioral risk behaviors for HIV infection among donors are critical steps to assessing and reducing risk of HIV transmission through blood transfusion. Detecting donors with recently acquired HIV infection is particularly critical as it enables characterization of the viral subtypes currently transmitted within the screened population. In addition to characterizing genotypes of recently infected donors for purposes of blood safety, molecular surveillance of incident HIV infections in blood donors serves important public health roles by identifying new HIV infections for anti-retroviral treatment, and enabling documentation of the rates of primary transmission of anti- viral drug resistant strains in the community. This study is a continuation of the current protocol that is approved by OMB, which expires on July 31, 2015, includes both a prospective surveillance and a case study designed to enroll eligible HIV seropositives detected at four participating blood centers in Brazil. This project is being conducted at the same four blood centers in Brazil, located in the cities of Sao Paulo, Recife, Rio de Janeiro and Belo Horizonte, but this time restricted to the study of HIV-positive subjects. The primary study aims are to continue monitoring HIV molecular variants and risk behaviors in blood donors in Brazil, and to evaluate HIV subtype and drug resistance profiles among HIV-positive donors according to HIV infection status (recent versus long-standing infection), year of donation, and site of collection. Additional study objectives include determining trends in HIV molecular variants and risk factors associated with HIV infection by combining data collected in the previous REDS-II project with that which will be obtained in the planned research activities. Given the initiation of NAT testing for HIV (and HCV) in Brazil, it will be important to continue to collect molecular surveillance and risk factor data on HIV infections. especially now that infections that might not have been identified by serology testing alone could be recognized through the use of NAT. NAT-only infections represent very recently acquired infections. The NAT assay will continue to be used at the four REDS-III blood centers in Brazil during the research activities. In addition, in order to distinguish between recent seroconversion and long-standing infection, samples from all HIV antibody dual reactive donations and/or NAT positive donations will continue to be tested by the Recent Infection Testing Algorithm (RITA) which is based on use of a sensitive/less-sensitive enzyme immunoassay (``detuned'' Enzyme Immunoassay). RITA testing will continue to be performed by the Blood Systems Research Institute, San Francisco, California, USA, which is the REDS-III Central Laboratory. Since Dec 2012, the study has enrolled 223 HIV-positive donors (51 at Hemorio-Rio de Janeiro, 38 at Hemominas-Minas Gerais, 67 at Hemope- Pernambuco and 67 at Fundacao Pro-Sangue-Sao Paulo) with a target enrollment of 500 by 2017. It is important to continue the study and enroll more HIV infected donors to inform trend analyses. Preliminary evaluation of data has shown that respondent donors are completing the entire questionnaire including information about their risk behaviors. According to the Brazilian guidelines, blood donors are requested to return to the blood bank for HIV confirmatory testing and HIV counseling. Donors are invited to participate in the study through administration of informed consent when they return for HIV counseling. Once informed consent has been administered and enrollment has occurred, participants are asked to complete a confidential self- administered risk factor questionnaire by computer. In addition, a small blood sample is collected from each HIV-positive participant to be used for the genotyping and drug resistance testing. The results of the drug resistance testing are communicated back to the HIV-positive participants during an in-person counseling session at the blood center. For those individuals who do not return for confirmatory testing, the samples will be anonymized and sent to the REDS-III Central Laboratory to perform the recent infection testing algorithm (RITA). This research effort will allow for an evaluation of trends in the trafficking of non-B HIV subtypes and rates of transmission of drug resistant viral strains in low risk blood donors. These data could also be compared with data from similar studies in higher risk populations. Monitoring drug resistance strains is extremely important in a country that provides free anti-retroviral therapy for HIV infected individuals, many of whom have low level education and modest resources, thus making compliance with drug regimens and hence the risk of drug resistant HIV a serious problem. It is worth noting that Brazil is the first developing country to implement early treatment initiation for all individuals living with HIV/AIDS irrespective of CD4 count; this new universal treatment policy went into effect in 2014. Findings from this study will be compared to trends in prevalence, incidence, and molecular variants from studies of the general population and high risk populations in Brazil, thus allowing for broader and more effective monitoring of the HIV epidemic in Brazil, as well as assessment of the impact of donor selection criteria on these parameters. We also propose to continue to examine trends in risk behaviors by comparing the data previously collected to the data we plan to collect for the next three year period. This will allow for extended trend analyses over a 10-year period that complements similar monitoring of HIV prevalence, incidence, transfusion risk and molecular variants in the USA and other funded international REDS-III sites in South Africa and China, thus allowing direct comparisons of these parameters on a global level. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 40. ---------------------------------------------------------------------------------------------------------------- Number of Average burden Total Form name Type of Number of responses per per response annual respondent respondents respondent (in hours) burden hour ---------------------------------------------------------------------------------------------------------------- Risk Factor Informed Consent....... Adult Donors 100 1 5/60 8 [[Page 15220]] Risk Factor Assessment............. Adult Donors 100 1 19/60 40 ---------------------------------------------------------------------------------------------------------------- Dated: March 11, 2015. Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2015-06565 Filed 3-20-15; 8:45 am] BILLING CODE 4141-01-P
![15218 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
Dated: March 17, 2015. letter, which finds Licensee’s kit to be a Freedom of Information Act, 5 U.S.C.
Leslie Kux, medical device substantially equivalent to 552.
Associate Commissioner for Policy. one or more similar legally marketed devices,
and states that the Licensee’s device can be Dated: March 17, 2015.
[FR Doc. 2015–06498 Filed 3–20–15; 8:45 am] marketed in the U.S. (i.e., 510(k) cleared), Richard U. Rodriguez,
BILLING CODE 4164–01–P such test kit to be distributed in commerce Acting Director, Office of Technology
for the purpose of predicting survival, Transfer, National Institutes of Health.
response to therapy, or cancer recurrence in [FR Doc. 2015–06487 Filed 3–20–15; 8:45 am]
DEPARTMENT OF HEALTH AND breast cancer patients.’’
BILLING CODE 4140–01–P
HUMAN SERVICES Upon the expiration or termination of
National Institutes of Health the exclusive evaluation option license,
ProVivoX, Inc., will have the exclusive DEPARTMENT OF HEALTH AND
Prospective Grant of Exclusive right to execute an exclusive HUMAN SERVICES
License: The Development of commercialization license which will
supersede and replace the exclusive National Institutes of Health
Theranostic Kits for mTOR Analog-
based Chemotherapy evaluation option license with no Submission for OMB Review; 30-Day
greater field of use and territory than Comment Request Prevalence,
AGENCY: National Institutes of Health, granted in the exclusive evaluation
HHS. Incidence, Epidemiology and
option license. Molecular Variants of HIV in Blood
ACTION: Notice.
DATES: Only written comments or Donors in Brazil (NHLBI)
SUMMARY: This is notice, in accordance applications for a license (or both)
which are received by the NIH Office of SUMMARY: Under the provisions of
with 35 U.S.C. 209 and 37 CFR part 404,
Technology Transfer on or before April Section 3507(a)(1)(D) of the Paperwork
that the National Institutes of Health,
7, 2015 will be considered. Reduction Act of 1995, the National
Department of Health and Human
Heart, Lung, and Blood Institute
Services, is contemplating the grant to ADDRESSES: Requests for copies of the
(NHLBI), the National Institutes of
ProVivoX, Inc., of an exclusive patent application, inquiries, comments,
Health (NIH) has submitted to the Office
evaluation option license to practice the and other materials relating to the of Management and Budget (OMB) a
inventions embodied in the following contemplated exclusive evaluation request for review and approval of the
US Patent, US Patent Application, and option license should be directed to: information collection listed below.
International Patent Application (and all Patrick McCue, Ph.D., Licensing and This proposed information collection
foreign counterparts): US Provisional Patenting Manager, Office of was previously published in the FR in
Patent Application Serial No. 61/ Technology Transfer, National Institutes Volume 79 on December 31, 2014 on
144,501, filed 14 January 2009, entitled: of Health, 6011 Executive Boulevard, page 78876 and allowed 60-days for
‘‘Ratio-based Biomarker of Survival Suite 325, Rockville, MD 20852–3804; public comment. One public comment
Utilizing PTEN and Phospho-AKT’’ Telephone: (301) 435–5560; Facsimile: was received that was a personal
[HHS Reference No. E–025–2009/0–US– (301) 402–0220; Email: mccuepat@ opinion regarding conducting research
01]; International Application No. PCT/ mail.nih.gov. about the Brazil blood donation system.
US2010/020944, filed on 13 January SUPPLEMENTARY INFORMATION: The The purpose of this notice is to allow an
2010, entitled: ‘‘Ratio-based Biomarkers technology describes a method of additional 30 days for public comment.
and Methods of Use Thereof’’ [HHS identifying cancer patients that may The National Institutes of Health may
Reference No. E–025–2009/0–PCT–02]; benefit from mTOR analog-based not conduct or sponsor, and the
US Patent Application Serial No. 13/ chemotherapy or agents directed against respondent is not required to respond
144,474, filed 13 July 2011 [HHS the AKT pathway. to, an information collection that has
Reference No. E–025–2009/0–US–02]; The prospective exclusive evaluation been extended, revised, or implemented
and Canadian Patent Application No. license is being considered under the on or after October 1, 1995, unless it
2,749,601, filed on 13 January 2010 small business initiative launched on 1 displays a currently valid OMB control
[HHS Reference No. E–025–2009/0–CA– October 2011, and will comply with the number.
05]. The patent rights in this invention terms and conditions of 35 U.S.C. 209 Direct Comments To Omb: Written
have been assigned to the Government and 37 CFR part 404. The prospective comments and/or suggestions regarding
of the United States of America. exclusive evaluation option license, and the item(s) contained in this notice,
The prospective exclusive evaluation especially regarding the estimated
a subsequent exclusive
option license territory may be United public burden and associated response
commercialization license, may be
States and Canada, and the field of use time, should be directed to the: Office
granted unless the NIH receives written
may be limited to: of Management and Budget, Office of
evidence and argument that establishes
a. ‘‘Exclusive use of the Licensed Patent that the grant of the license would not Regulatory Affairs, OIRA_submission@
Rights to develop an immunohistochemistry be consistent with the requirements of omb.eop.gov or by fax to 202–395–6974,
(IHC)- or tissue microarray-based test kit for Attention: Desk Officer for NIH.
use with human tissue samples and approved
35 U.S.C. 209 and 37 CFR part 404
in the United States and Canada as a Class within fifteen (15) days from the date of Comments Due Date: Comments
III medical device, such test kit to be this published notice. regarding this information collection are
distributed in commerce for the for the Complete applications for a license in best assured of having their full effect if
received within 30 days of the date of
mstockstill on DSK4VPTVN1PROD with NOTICES
purpose of predicting survival, response to the field of use filed in response to this
therapy, or cancer recurrence in breast cancer notice will be treated as objections to this publication.
patients.’’ the grant of the contemplated exclusive FOR FURTHER INFORMATION CONTACT: To
b. ‘‘Non-exclusive use of the Licensed evaluation option license. Comments obtain a copy of the data collection
Patent Rights to develop an
immunohistochemistry (IHC)- or tissue and objections submitted to this notice plans and instruments or request more
microarray-based test kit for use with human will not be made available for public information on the proposed project
tissue samples and for which the United inspection and, to the extent permitted contact: Simone Glynn, MD, Project
States FDA issues an order, in the form of a by law, will not be released under the Officer/ICD Contact, Two Rockledge
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![15220 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
Average Total
Number of
Type of Number of burden per annual
Form name responses per
respondent respondents response burden
respondent (in hours) hour
Risk Factor Assessment .......................................................... Adult Donors 100 1 19/60 40
Dated: March 11, 2015. Improvement and Patient Safety, AHRQ, DEPARTMENT OF HEALTH AND
Lynn Susulske, 540 Gaither Road, Rockville, MD 20850; HUMAN SERVICES
NHLBI Project Clearance Liaison, National Telephone (toll free): (866) 403–3697;
Institutes of Health. Telephone (local): (301) 427–1111; TTY National Institutes of Health
[FR Doc. 2015–06565 Filed 3–20–15; 8:45 am] (toll free): (866) 438–7231; TTY (local):
Prospective Grant of an Exclusive
BILLING CODE 4141–01–P (301) 427–1130; Email: PSO@
Commercial License Agreement:
AHRQ.hhs.gov.
Development of 5T4 Antibody-Drug
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: Conjugates for the Treatment of
HUMAN SERVICES Human Cancers
Background
AGENCY: National Institutes of Health,
Agency for Healthcare Research and The Patient Safety Act authorizes the HHS.
Quality
listing of PSOs, which are entities or ACTION: Notice.
Patient Safety Organizations: Expired component organizations whose
mission and primary activity are to SUMMARY: This is notice, in accordance
Listing From Premerus PSO, LLC with 35 U.S.C. 209 and 37 CFR part 404,
conduct activities to improve patient
AGENCY: Agency for Healthcare Research that the National Institutes of Health,
safety and the quality of health care
and Quality (AHRQ), Department of Department of Health and Human
delivery.
Health and Human Services (HHS). Services, is contemplating the grant of
HHS issued the Patient Safety Rule to an start-up exclusive commercial
ACTION: Notice of delisting.
implement the Patient Safety Act. license to practice the inventions
SUMMARY: The Patient Safety and AHRQ administers the provisions of the embodied in U.S. Patent Application
Quality Improvement Act of 2005, 42 Patient Safety Act and Patient Safety No. 62/034,995 entitled ‘‘Human
U.S.C. 299b–21 to b–26, (Patient Safety Rule relating to the listing and operation Monoclonal Antibodies Specific for 5T4
Act) and the related Patient Safety and of PSOs. The Patient Safety Rule and Methods of Their Use’’ filed August
Quality Improvement Final Rule, 42 authorizes AHRQ to list as a PSO an 8, 20014 [HHS Ref. E–158–2014/0–US–
CFR part 3 (Patient Safety Rule), entity that attests that it meets the 01] and all related continuing and
published in the Federal Register on statutory and regulatory requirements foreign patents/patent applications for
November 21, 2008, (73 FR 70732– for listing. A PSO can be ‘‘delisted’’ if the technology family to Concortis, Inc.
70814), provide for the formation of it is found to no longer meet the The patent rights in these inventions
Patient Safety Organizations (PSOs), requirements of the Patient Safety Act have been assigned to the Government
which collect, aggregate, and analyze and Patient Safety Rule, when a PSO of the United States of America. The
confidential information regarding the chooses to voluntarily relinquish its prospective start-up exclusive
quality and safety of healthcare status as a PSO for any reason, or when commercial license territory may be
delivery. The Patient Safety Rule the PSO’s listing expires. Section worldwide and the field of use may be
authorizes AHRQ, on behalf of the limited to the development of 5T4
3.108(d) of the Patient Safety Rule
Secretary of HHS, to list as a PSO an antibody drug conjugate therapeutics for
requires AHRQ to provide public notice
entity that attests that it meets the the treatment of human cancers using
when it removes an organization from Concortis’ proprietary conjugation
statutory and regulatory requirements
the list of federally approved PSOs. technologies.
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer Premerus PSO, LLC, PSO number
P0120, a component entity of Premerus, DATES: Only written comments and/or
meet the requirements of the Patient applications for a license which are
Safety Act and Patient Safety Rule, Inc., chose to let its listing expire by not
seeking continued listing. Accordingly, received by the NIH Office of
when a PSO chooses to voluntarily Technology Transfer on or before April
relinquish its status as a PSO for any Premerus PSO, LLC was delisted
7, 2015 will be considered.
reason, or when a PSO’s listing expires. effective at 12:00 Midnight ET (2400) on
ADDRESSES: Requests for copies of the
The listing from the Premerus PSO, LLC January 10, 2015.
patent applications, inquiries,
has expired and AHRQ has delisted the More information on PSOs can be comments, and other materials relating
PSO accordingly. obtained through AHRQ’s PSO Web site to the contemplated exclusive
DATES: The directories for both listed at http://www.pso.AHRQ.gov/ evaluation option license should be
and delisted PSOs are ongoing and index.html. directed to: Whitney Hastings, Ph.D.,
reviewed weekly by AHRQ. The Dated: March 17, 2015. Senior Licensing and Patenting
delisting was effective at 12:00 Midnight Manager, Office of Technology Transfer,
mstockstill on DSK4VPTVN1PROD with NOTICES
ET (2400) on January 10, 2015. Sharon B. Arnold,
National Institutes of Health, 6011
ADDRESSES: Both directories can be Deputy Director, AHRQ.
Executive Boulevard, Suite 325,
accessed electronically at the following [FR Doc. 2015–06454 Filed 3–20–15; 8:45 am] Rockville, MD 20852–3804; Telephone:
HHS Web site: http:// BILLING CODE 4160–90–P (301) 451–7337; Facsimile: (301) 402–
www.pso.AHRQ.gov/index.html. 0220; Email: hastingw@mail.nih.gov.
FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: 5T4 is an
Eileen Hogan, Center for Quality antigen expressed in a number of
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Document Created: 2018-02-21 09:47:25
Document Modified: 2018-02-21 09:47:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| Contact | To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call | |
| FR Citation | 80 FR 15218 |
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