Nominations to the National Toxicology Program for the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information, 62513-62514 [2016-21698]

Download as PDF 62513 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Small Rural Hospital Transitions Project OMB No. 0906–xxxx—NEW Abstract: Under Section 330A of the Public Health Service Act (42 U.S.C. 254c(e)), the Federal Office of Rural Health Policy (FORHP) funds grant programs supporting expanding access to, and improving the quality of essential health care services in rural and frontier communities. Small rural hospitals are facing many challenges in the new health care environment, including the concurrent need to better measure and account for quality of care in all settings; improving transitions of care as patients move from one care setting to another; adopting new payment approaches such as valuebased purchasing; and tailoring operations to the new approaches to care delivery, such as accountable care organizations (ACO) and patientcentered medical homes. Success in this new environment will require bridging the gaps between the current system and the newly emerging system of healthcare delivery and payment. Because little is known about how these new models might impact rural communities, there is a need to help hospitals understand and consider those factors that would make them logical participants in health care systems that focus on value. The Small Rural Hospital Transitions (SRHT) Project will assist small rural hospitals in making the transition. The purpose of the project is to provide on-site technical assistance to nine small rural hospitals located in persistent poverty counties. Technical assistance will be provided in the areas of: (1) Financial assessments, (2) creating a quality-focused environment, (3) aligning services to community need, and, (4) to the extent that financial and quality core areas have been stabilized, assistance to help the hospitals consider factors that would make them logical participants in health care systems that focus on value (for example ACOs, shared savings programs, primary care medical homes). Need and Proposed Use of the Information: The information will be solicited in the form of the SRHT Project Technical Assistance Online Application form and the supporting hospital assessment, Performance Excellence for Rural Hospitals. All small rural hospitals desiring to apply for onsite technical assistance through SRHT will be required to complete the application and the survey. The applicant’s information will be scored and ranked to aid in the selection of nine small rural hospitals to receive onsite technical assistance. Both the application form and the hospital assessment are designed to ensure the selection of hospital applicants consistent with established eligibility criteria and hospitals readiness or ability to implement consultant’s recommendations. A 60-day Federal Register Notice was published in the Federal Register on June 24, 2016 (81 FR 41315). There were no public comments. Likely Respondents: Small rural hospitals located in a rural community, as defined by FORHP, persistent poverty county, or a rural census tract of a metro persistent poverty county; have 49 staffed beds or less as reported on the hospital’s most recently filed Medicare Cost Report. Hospitals; and for-profit or not-for-profit. 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 Number of respondents Form name Number of responses per respondent Average burden per response (in hours) Total responses Total burden hours SRHT Project Technical Assistance Online Application ..... Assessment: Performance Excellence for Rural Hospitals 30 30 38 29 1140 870 .50 .25 570 217.5 Total .............................................................................. * 30 ........................ 2010 ........................ 787.5 * The same individuals complete the SRHT Online Application and the Assessment for a total of 30 respondents. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016–21733 Filed 9–8–16; 8:45 am] asabaliauskas on DSK3SPTVN1PROD with NOTICES BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Nominations to the National Toxicology Program for the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information The National Toxicology Program (NTP) requests information on four nominations. Four substances are being considered for possible review for future editions of the Report on Carcinogens (RoC). Three of these four substances are also being considered for SUMMARY: VerDate Sep<11>2014 17:11 Sep 08, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 evaluation of non-cancer health outcomes by the Office of Health Assessment and Translation (OHAT). DATES: Receipt of information: Deadline is October 11, 2016. ADDRESSES: Information on substances for possible review should be submitted electronically at https:// ntp.niehs.nih.gov/go/778417. FOR FURTHER INFORMATION CONTACT: RoC Nominations: Dr. Ruth Lunn, Director, Office of RoC; telephone (919) 316–4637; lunn@niehs.nih.gov. OHAT Nominations: Dr. Windy Boyd, OHAT, telephone (919) 541–9810; boydw@ niehs.nih.gov. Address for Dr. Lunn and Dr. Boyd: Division of NTP, National E:\FR\FM\09SEN1.SGM 09SEN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES 62514 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, P.O. Box 12233, Research Triangle Park, NC 27709. SUPPLEMENTARY INFORMATION: Request for Information: NTP requests information on four substances that have been nominated for possible review for future editions of the RoC (see https://ntp.niehs.nih.gov/go/ rocnom); three of these four substances are also under consideration for evaluation of non-cancer health outcomes (see https://ntp.niehs.nih.gov/ go/763346). The four nominations are: • Consumption of red meat: cancer and non-cancer health hazard evaluations. • Consumption of processed meat: cancer and non-cancer health hazard evaluations. • Consumption of meat cooked at high temperatures: cancer and noncancer health hazard evaluations. • Antimony trioxide: cancer hazard evaluation. Cancer hazard evaluation of a substance for the RoC may seek to list a new substance in the report, reclassify the listing status of a substance already listed, or remove a listed substance. Specifically, NTP requests information on: (1) Current production, use patterns, and human exposure estimates for antimony trioxide; (2) data on dietary intake estimates of red meat, processed meat, or meat cooked at high temperatures; and for all four nominations (3) recently published, ongoing, or planned studies related to evaluating adverse health outcomes (e.g., cancer, development, reproductive, or immunological disorders); (4) scientific issues important for prioritizing and assessing adverse health outcomes; and (5) names of scientists with expertise or knowledge on any of these substances— please indicate the substance and include any bibliographic citations when available. NTP will use this information in determining which substances to propose for formal health hazard evaluations. Information on substances for possible review should be submitted electronically at https:// ntp.niehs.nih.gov/go/778417 or emailed to Dr. Lunn or Dr. Boyd (see FOR FURTHER INFORMATION CONTACT). Contact information for comments should include the submitter’s name, affiliation, sponsoring organization (if any), telephone, and email. Written information received in response to this notice will be posted on the NTP Web site, and the submitter identified by name, affiliation, and/or sponsoring VerDate Sep<11>2014 17:11 Sep 08, 2016 Jkt 238001 organization. Guidelines for public comments are at https:// ntp.niehs.nih.gov/ntp/about_ntp/ guidelines_public_comments_508.pdf. Responses to this request for information are voluntary. This request for information is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use. No proprietary, classified, confidential, or sensitive information should be included in your response. Background Information on ORoC: On behalf of NTP, ORoC prepares the RoC following an established, four-part process (https://ntp.niehs.nih.gov/go/ rocprocess). The RoC is a congressionally mandated, sciencebased, public health report that identifies agents, substances, mixtures, or exposures (collectively called ‘‘substances’’) in our environment that pose a cancer hazard for people in the United States. Published biennially, each edition of the RoC is cumulative and consists of substances newly reviewed in addition to those listed in previous editions. Newly reviewed substances with their recommended listing are reviewed and approved by the Secretary of Health and Human Services. The 13th RoC, the latest edition, was published on October 2, 2014 (available at https:// ntp.niehs.nih.gov/go/roc13). The 14th RoC is under development. Background Information on OHAT: On behalf of NTP, OHAT conducts literature-based evaluations to assess the evidence whether environmental chemicals, physical substances, or mixtures (collectively called ‘‘substances’’) cause adverse non-cancer health outcomes. As part of these evaluations, NTP may also provide opinions on whether these substances might be of concern for causing adverse effects on human health given what is known about toxicity and current human exposure levels. Information about OHAT can be found at https:// ntp.niehs.nih.gov/go/ohat. Dated: September 6, 2016. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2016–21698 Filed 9–8–16; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892–2479; telephone: 301–402–5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. SUMMARY: Reagent for Mapping Genome-Wide Enhancer-Promoter Interactions This invention is a research reagent named the ‘‘bivalent Tn5 complex’’ used in transposition-mediated analysis of chromatin looping (TrAC-looping) to determine genome-wide enhancerpromoter interactions during studies of 4D nucleomes in normal development and disease conditions. Enhancerpromoter interactions are key in temporospatial control of gene expression during normal development and pathological conditions. Currently available methods of analyzing genomewide enhancer-promoter interactions are insufficient in achieving necessary resolution, give rise to false positive artifacts due to in vitro ligation steps, or too expensive due to the necessity of sequencing over a billion reads. The instant reagent and associated TrAClooping technique effectively reduce false positive detection and achieve a 10 to 100-times higher resolution at lower cost for mapping genome-wide interactions between enhancers and promotes essential for the control of gene expression in normal development and pathological conditions. References —Lieberman-Aiden E et al., Science 2009 Oct 9;326(5950):289–93. E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62513-62514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21698]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Nominations to the National Toxicology Program for the Report on 
Carcinogens and Office of Health Assessment and Translation; Request 
for Information

SUMMARY: The National Toxicology Program (NTP) requests information on 
four nominations. Four substances are being considered for possible 
review for future editions of the Report on Carcinogens (RoC). Three of 
these four substances are also being considered for evaluation of non-
cancer health outcomes by the Office of Health Assessment and 
Translation (OHAT).

DATES: Receipt of information: Deadline is October 11, 2016.

ADDRESSES: Information on substances for possible review should be 
submitted electronically at https://ntp.niehs.nih.gov/go/778417.

FOR FURTHER INFORMATION CONTACT: 
    RoC Nominations: Dr. Ruth Lunn, Director, Office of RoC; telephone 
(919) 316-4637; lunn@niehs.nih.gov. OHAT Nominations: Dr. Windy Boyd, 
OHAT, telephone (919) 541-9810; boydw@niehs.nih.gov. Address for Dr. 
Lunn and Dr. Boyd: Division of NTP, National

[[Page 62514]]

Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, 
P.O. Box 12233, Research Triangle Park, NC 27709.

SUPPLEMENTARY INFORMATION: 
    Request for Information: NTP requests information on four 
substances that have been nominated for possible review for future 
editions of the RoC (see https://ntp.niehs.nih.gov/go/rocnom); three of 
these four substances are also under consideration for evaluation of 
non-cancer health outcomes (see https://ntp.niehs.nih.gov/go/763346). 
The four nominations are:
     Consumption of red meat: cancer and non-cancer health 
hazard evaluations.
     Consumption of processed meat: cancer and non-cancer 
health hazard evaluations.
     Consumption of meat cooked at high temperatures: cancer 
and non-cancer health hazard evaluations.
     Antimony trioxide: cancer hazard evaluation.
    Cancer hazard evaluation of a substance for the RoC may seek to 
list a new substance in the report, reclassify the listing status of a 
substance already listed, or remove a listed substance.
    Specifically, NTP requests information on: (1) Current production, 
use patterns, and human exposure estimates for antimony trioxide; (2) 
data on dietary intake estimates of red meat, processed meat, or meat 
cooked at high temperatures; and for all four nominations (3) recently 
published, ongoing, or planned studies related to evaluating adverse 
health outcomes (e.g., cancer, development, reproductive, or 
immunological disorders); (4) scientific issues important for 
prioritizing and assessing adverse health outcomes; and (5) names of 
scientists with expertise or knowledge on any of these substances--
please indicate the substance and include any bibliographic citations 
when available. NTP will use this information in determining which 
substances to propose for formal health hazard evaluations.
    Information on substances for possible review should be submitted 
electronically at https://ntp.niehs.nih.gov/go/778417 or emailed to Dr. 
Lunn or Dr. Boyd (see FOR FURTHER INFORMATION CONTACT). Contact 
information for comments should include the submitter's name, 
affiliation, sponsoring organization (if any), telephone, and email. 
Written information received in response to this notice will be posted 
on the NTP Web site, and the submitter identified by name, affiliation, 
and/or sponsoring organization. Guidelines for public comments are at 
https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
    Responses to this request for information are voluntary. This 
request for information is for planning purposes only and is not a 
solicitation for applications or an obligation on the part of the U.S. 
Government to provide support for any ideas identified in response to 
it. Please note that the U.S. Government will not pay for the 
preparation of any information submitted or for its use. No 
proprietary, classified, confidential, or sensitive information should 
be included in your response.
    Background Information on ORoC: On behalf of NTP, ORoC prepares the 
RoC following an established, four-part process (https://ntp.niehs.nih.gov/go/rocprocess). The RoC is a congressionally 
mandated, science-based, public health report that identifies agents, 
substances, mixtures, or exposures (collectively called ``substances'') 
in our environment that pose a cancer hazard for people in the United 
States. Published biennially, each edition of the RoC is cumulative and 
consists of substances newly reviewed in addition to those listed in 
previous editions. Newly reviewed substances with their recommended 
listing are reviewed and approved by the Secretary of Health and Human 
Services. The 13th RoC, the latest edition, was published on October 2, 
2014 (available at https://ntp.niehs.nih.gov/go/roc13). The 14th RoC is 
under development.
    Background Information on OHAT: On behalf of NTP, OHAT conducts 
literature-based evaluations to assess the evidence whether 
environmental chemicals, physical substances, or mixtures (collectively 
called ``substances'') cause adverse non-cancer health outcomes. As 
part of these evaluations, NTP may also provide opinions on whether 
these substances might be of concern for causing adverse effects on 
human health given what is known about toxicity and current human 
exposure levels. Information about OHAT can be found at https://ntp.niehs.nih.gov/go/ohat.

    Dated: September 6, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-21698 Filed 9-8-16; 8:45 am]
BILLING CODE 4140-01-P
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