Request for Public Comment; 60 Day Proposed Information Collection: Mashpee Wampanoag Indian Health Service Unit Community Health Assessment, 11361-11362 [2017-03407]

Download as PDF 11361 Federal Register / Vol. 82, No. 34 / Wednesday, February 22, 2017 / Notices respondents’ time to submit their data. The cost burden is estimated to be $11,222 annually. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents/ POCs Form name Number of responses per POC Hours per response Total burden hours Eligibility and Registration Form ...................................................................... Data Use Agreement ....................................................................................... Pharmacy Site Information Form ..................................................................... Data Files Submission ..................................................................................... 150 150 150 150 1 1 3 1 5/60 3/60 5/60 1 13 8 38 150 Total .......................................................................................................... NA NA NA 209 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents/ POCs Form name Total burden hours Average hourly wage rate * Total cost burden Eligibility and Registration Form ...................................................................... Data Use Agreement ....................................................................................... Pharmacy Site Information Form ..................................................................... Data Files Submission ..................................................................................... 150 150 150 150 13 8 38 150 $53.69 53.69 53.69 53.69 $698 430 2,040 8,054 Total .......................................................................................................... NA 209 NA 11,222 * Based on the weighted average hourly wage in community pharmacies for 100 General and Operations Managers (11–1021; $49.26) and 50 General and Operations Managers (11–1021; $62.56) obtained from the May 2015 National Industry-Specific Occupational Employment and Wage Estimates: NAICS 446110—Pharmacies and Drug Stores (located at http://www.bls.gov/oes/current/naics5_446110.htm) and NAICS 622000—Hospitals (located at http://www.bls.gov/oes/current/naics3_622000.htm). sradovich on DSK3GMQ082PROD with NOTICES Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501–3521, AHRQ invites the public to comment on this proposed information collection. This is a second review opportunity. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All VerDate Sep<11>2014 16:05 Feb 21, 2017 Jkt 241001 comments will become a matter of public record. Sharon B. Arnold, Acting Director. [FR Doc. 2017–03463 Filed 2–21–17; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request for Public Comment; 60 Day Proposed Information Collection: Mashpee Wampanoag Indian Health Service Unit Community Health Assessment AGENCY: Indian Health Service, HHS. Notice and request for comments. ACTION: In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the new information collection Office of Management and Budget (OMB) Control Number 0917– NEW, titled, ‘‘Mashpee Wampanoag Community Health Assessment.’’ The purpose of this notice is to allow 60 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is SUMMARY: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 available at www.regulations.gov (see Docket ID [IHS–2017–0001]). DATES: April 24, 2017. Your comments regarding this information collection are best assured of having full effect if received within 60 days of the date of this publication. ADDRESSES: Send your written comments, requests for more information on the collection, or requests to obtain a copy of the data collection instrument and instructions to Rita Gonsalves by one of the following methods: • Mail: Ms. Rita Gonsalves, CEO, Mashpee Wampanoag Health Service Unit, Indian Health Service, 483B Great Neck Rd. South, Mashpee, MA 02346. • Phone: 508–477–6913. • Email: Rita.Gonsalves@ihs.gov. • Fax: 508–477–0156. SUPPLEMENTARY INFORMATION: The Indian Health Service Mashpee Wampanoag Service Unit is submitting the proposed information collection to OMB for review, as required by section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995. This notice is soliciting comments from members of the public and affected agencies as required by 44 U.S.C. 3506(c)(2)(A) concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have E:\FR\FM\22FEN1.SGM 22FEN1 11362 Federal Register / Vol. 82, No. 34 / Wednesday, February 22, 2017 / Notices practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques of other forms of information technology, e.g., permitting electronic submission of responses. Title of Proposal: Mashpee Wampanoag Indian Health Service Unit Community Health Assessment. Type of Information Collection Request: Three year approval of this new information collection. OMB Control Number: To be assigned. Need and Use of Information Collection: The Mashpee Wampanoag Indian Health Service (IHS) Unit seeks to conduct a health assessment of the Mashpee Wampanoag Tribe. The collection of information will be used to evaluate the health care needs of the Mashpee Wampanoag Tribal community. As a healthcare organization, the Mashpee Wampanoag Health Service Unit has questions regarding a respondent’s health status, behavior and social practices as well as environmental concerns. These answers will help the organization assess healthcare needs of the community and guide the implementation of programs. The Mashpee Wampanoag Health Service Unit will be able to assess the community’s needs and plan our Number of responses per respondent programs accordingly to improve the health and well-being of the community. Status of the Proposed Information Collection: New request. Form(s): IHS Mashpee Wampanoag Community Health Assessment Questionnaire. Agency Form Numbers: None. Members of Affected Public: The Mashpee Wampanoag Tribal community members in the Mashpee Wampanoag Tribal service area. The table below provides: Type of data collection instrument, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s). Total annual response Average burden per response (hours) Estimated burden hours Data collection instrument Type of respondents Community Health Assessment ........ Individuals ........................................ 1 469 25/60 195 Total ........................................... ........................................................... 1 469 25/60 195 received by the National Cancer Institute’s Technology Transfer Center on or before March 9, 2017 will be considered. There are no direct costs to respondents to report. Dated: February 10, 2017. Chris Buchanan, Assistant Surgeon General, USPHS, Acting Director, Indian Health Service. [FR Doc. 2017–03407 Filed 2–21–17; 8:45 am] BILLING CODE 4160–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Development of a Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient Response to Transcatheter Arterial Chemoembolization (TACE) AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to 3D Medicines (‘‘3DMed’’) located in Shanghai, China. DATES: Only written comments and/or applications for a license which are sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:05 Feb 21, 2017 Jkt 241001 Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Jim Knabb, Ph.D., Technology Transfer and Patent Specialist, 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– 5530; Facsimile: (240) 276–5504; Email: jim.knabb@nih.gov. ADDRESSES: SUPPLEMENTARY INFORMATION: Intellectual Property United States Provisional Patent Application No. 62/292,789, filed February 8, 2016 entitled ‘‘Gene Signature Predictive of Hepatocellular Carcinoma Response to Transcatheter Arterial Chemoembolization’’ [HHS Reference No. E–101–2016/0–US–01]; PCT Patent Application PCT/US2017/ 016851, filed February 7, 2017 and entitled ‘‘GENE SIGNATURE PREDICTIVE OF HEPATOCELLULAR CARCINOMA RESPONSE TO TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE)’’ [HHS Reference No. E–101–2016/0– PCT–02]; (and U.S. and foreign patent PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 applications claiming priority to the aforementioned applications). 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 Development and commercialization of the transcatheter arterial chemoembolization (TACE) gene signature as a diagnostic device predictive of TACE response in patients with hepatocellular carcinoma (HCC). The field of use may be further limited to companion diagnostic tests that are sold following Premarket Approval by the FDA or equivalent regulatory agency in foreign jurisdictions’’. This technology discloses a gene expression signature that is predictive of HCC patient response to TACE. TACE therapy is a procedure whereby the tumor is targeted with both local chemotherapy and restriction of local blood supply, and is employed in the treatment of locally advanced hepatocellular carcinoma (HCC). Patient biopsies are analyzed by NextGeneration Sequencing (NGS) and expression analysis of the gene signature can be used to stratify patients for TACE therapy. Through the commercialization of this gene signature for TACE efficacy, HCC patients can be identified as candidates for TACE E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 82, Number 34 (Wednesday, February 22, 2017)]
[Notices]
[Pages 11361-11362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03407]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Request for Public Comment; 60 Day Proposed Information 
Collection: Mashpee Wampanoag Indian Health Service Unit Community 
Health Assessment

AGENCY: Indian Health Service, HHS.

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
Indian Health Service (IHS) invites the general public to take this 
opportunity to comment on the new information collection Office of 
Management and Budget (OMB) Control Number 0917-NEW, titled, ``Mashpee 
Wampanoag Community Health Assessment.'' The purpose of this notice is 
to allow 60 days for public comment to be submitted directly to OMB. A 
copy of the draft supporting statement is available at 
www.regulations.gov (see Docket ID [IHS-2017-0001]).

DATES: April 24, 2017. Your comments regarding this information 
collection are best assured of having full effect if received within 60 
days of the date of this publication.

ADDRESSES: Send your written comments, requests for more information on 
the collection, or requests to obtain a copy of the data collection 
instrument and instructions to Rita Gonsalves by one of the following 
methods:
     Mail: Ms. Rita Gonsalves, CEO, Mashpee Wampanoag Health 
Service Unit, Indian Health Service, 483B Great Neck Rd. South, 
Mashpee, MA 02346.
     Phone: 508-477-6913.
     Email: Rita.Gonsalves@ihs.gov.
     Fax: 508-477-0156.

SUPPLEMENTARY INFORMATION: The Indian Health Service Mashpee Wampanoag 
Service Unit is submitting the proposed information collection to OMB 
for review, as required by section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995. This notice is soliciting comments from members 
of the public and affected agencies as required by 44 U.S.C. 
3506(c)(2)(A) concerning the proposed collection of information to: (1) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have

[[Page 11362]]

practical utility; (2) Evaluate the accuracy of the agency's estimate 
of the burden of the proposed collection of information; (3) Enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) Minimize the burden of the collection of information on those 
who are to respond; including through the use of appropriate automated 
collection techniques of other forms of information technology, e.g., 
permitting electronic submission of responses.
    Title of Proposal: Mashpee Wampanoag Indian Health Service Unit 
Community Health Assessment.
    Type of Information Collection Request: Three year approval of this 
new information collection.
    OMB Control Number: To be assigned.
    Need and Use of Information Collection: The Mashpee Wampanoag 
Indian Health Service (IHS) Unit seeks to conduct a health assessment 
of the Mashpee Wampanoag Tribe. The collection of information will be 
used to evaluate the health care needs of the Mashpee Wampanoag Tribal 
community. As a healthcare organization, the Mashpee Wampanoag Health 
Service Unit has questions regarding a respondent's health status, 
behavior and social practices as well as environmental concerns. These 
answers will help the organization assess healthcare needs of the 
community and guide the implementation of programs. The Mashpee 
Wampanoag Health Service Unit will be able to assess the community's 
needs and plan our programs accordingly to improve the health and well-
being of the community.
    Status of the Proposed Information Collection: New request.
    Form(s): IHS Mashpee Wampanoag Community Health Assessment 
Questionnaire.
    Agency Form Numbers: None.
    Members of Affected Public: The Mashpee Wampanoag Tribal community 
members in the Mashpee Wampanoag Tribal service area.
    The table below provides: Type of data collection instrument, 
Estimated number of respondents, Number of responses per respondent, 
Annual number of responses, Average burden hour per response, and Total 
annual burden hour(s).

----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
  Data collection instrument         Type of       responses per   Total annual    per response      Estimated
                                   respondents      respondent       response         (hours)      burden hours
----------------------------------------------------------------------------------------------------------------
Community Health Assessment...  Individuals.....               1             469           25/60             195
                                                 ---------------------------------------------------------------
    Total.....................  ................               1             469           25/60             195
----------------------------------------------------------------------------------------------------------------

    There are no direct costs to respondents to report.

    Dated: February 10, 2017.
Chris Buchanan,
Assistant Surgeon General, USPHS, Acting Director, Indian Health 
Service.
[FR Doc. 2017-03407 Filed 2-21-17; 8:45 am]
 BILLING CODE 4160-16-P