82_FR_11395 82 FR 11361 - Request for Public Comment; 60 Day Proposed Information Collection: Mashpee Wampanoag Indian Health Service Unit Community Health Assessment

82 FR 11361 - Request for Public Comment; 60 Day Proposed Information Collection: Mashpee Wampanoag Indian Health Service Unit Community Health Assessment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service

Federal Register Volume 82, Issue 34 (February 22, 2017)

Page Range11361-11362
FR Document2017-03407

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]).

Federal Register, Volume 82 Issue 34 (Wednesday, February 22, 2017)
[Federal Register Volume 82, Number 34 (Wednesday, February 22, 2017)]
[Notices]
[Pages 11361-11362]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].
     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



                                                                                    Federal Register / Vol. 82, No. 34 / Wednesday, February 22, 2017 / Notices                                                                   11361

                                                respondents’ time to submit their data.                                     The cost burden is estimated to be
                                                                                                                            $11,222 annually.

                                                                                                               EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                          Number of         Number of         Hours per      Total burden
                                                                                                 Form name                                                               respondents/       responses         response          hours
                                                                                                                                                                            POCs             per POC

                                                Eligibility and Registration Form ......................................................................                            150                 1             5/60             13
                                                Data Use Agreement .......................................................................................                          150                 1             3/60              8
                                                Pharmacy Site Information Form .....................................................................                                150                 3             5/60             38
                                                Data Files Submission .....................................................................................                         150                 1                1            150

                                                      Total ..........................................................................................................              NA                NA               NA             209


                                                                                                                EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
                                                                                                                                                                          Number of                            Average
                                                                                                                                                                                           Total burden                       Total cost
                                                                                                 Form name                                                               respondents/                           hourly
                                                                                                                                                                                              hours                            burden
                                                                                                                                                                            POCs                              wage rate *

                                                Eligibility and Registration Form ......................................................................                            150                13           $53.69          $698
                                                Data Use Agreement .......................................................................................                          150                 8            53.69            430
                                                Pharmacy Site Information Form .....................................................................                                150                38            53.69          2,040
                                                Data Files Submission .....................................................................................                         150               150            53.69          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).


                                                Request for Comments                                                        comments will become a matter of                                available at www.regulations.gov (see
                                                                                                                            public record.                                                  Docket ID [IHS–2017–0001]).
                                                  In accordance with the Paperwork                                                                                                          DATES: April 24, 2017. Your comments
                                                Reduction Act, comments on AHRQ’s                                           Sharon B. Arnold,
                                                                                                                                                                                            regarding this information collection are
                                                information collection are requested                                        Acting Director.
                                                                                                                                                                                            best assured of having full effect if
                                                with regard to any of the following: (a)                                    [FR Doc. 2017–03463 Filed 2–21–17; 8:45 am]                     received within 60 days of the date of
                                                Whether the proposed collection of                                          BILLING CODE 4160–90–P                                          this publication.
                                                information is necessary for the proper                                                                                                     ADDRESSES: Send your written
                                                performance of AHRQ health care                                                                                                             comments, requests for more
                                                research and health care information                                        DEPARTMENT OF HEALTH AND
                                                                                                                                                                                            information on the collection, or
                                                dissemination functions, including                                          HUMAN SERVICES
                                                                                                                                                                                            requests to obtain a copy of the data
                                                whether the information will have                                           Indian Health Service                                           collection instrument and instructions
                                                practical utility; (b) the accuracy of                                                                                                      to Rita Gonsalves by one of the
                                                AHRQ’s estimate of burden (including                                        Request for Public Comment; 60 Day                              following methods:
                                                hours and costs) of the proposed                                            Proposed Information Collection:                                  • Mail: Ms. Rita Gonsalves, CEO,
                                                collection(s) of information; (c) ways to                                   Mashpee Wampanoag Indian Health                                 Mashpee Wampanoag Health Service
                                                enhance the quality, utility, and clarity                                   Service Unit Community Health                                   Unit, Indian Health Service, 483B Great
                                                of the information to be collected; and                                     Assessment                                                      Neck Rd. South, Mashpee, MA 02346.
                                                (d) ways to minimize the burden of the                                                                                                        • Phone: 508–477–6913.
                                                                                                                            AGENCY:        Indian Health Service, HHS.                        • Email: Rita.Gonsalves@ihs.gov.
                                                collection of information upon the                                                                                                            • Fax: 508–477–0156.
                                                respondents, including the use of                                                 Notice and request for
                                                                                                                            ACTION:                                                         SUPPLEMENTARY INFORMATION: The
                                                automated collection techniques or                                          comments.                                                       Indian Health Service Mashpee
                                                other forms of information technology.                                                                                                      Wampanoag Service Unit is submitting
                                                  In accordance with the Paperwork                                          SUMMARY:   In compliance with the                               the proposed information collection to
                                                Reduction Act, 44 U.S.C. 3501–3521,                                         Paperwork Reduction Act of 1995, the                            OMB for review, as required by section
                                                AHRQ invites the public to comment on                                       Indian Health Service (IHS) invites the                         3507(a)(1)(D) of the Paperwork
                                                this proposed information collection.                                       general public to take this opportunity                         Reduction Act of 1995. This notice is
                                                This is a second review opportunity.                                        to comment on the new information                               soliciting comments from members of
                                                                                                                            collection Office of Management and                             the public and affected agencies as
sradovich on DSK3GMQ082PROD with NOTICES




                                                  Comments submitted in response to
                                                                                                                            Budget (OMB) Control Number 0917–                               required by 44 U.S.C. 3506(c)(2)(A)
                                                this notice will be summarized and
                                                                                                                            NEW, titled, ‘‘Mashpee Wampanoag                                concerning the proposed collection of
                                                included in the Agency’s subsequent                                         Community Health Assessment.’’ The                              information to: (1) Evaluate whether the
                                                request for OMB approval of the                                             purpose of this notice is to allow 60                           proposed collection of information is
                                                proposed information collection. All                                        days for public comment to be                                   necessary for the proper performance of
                                                                                                                            submitted directly to OMB. A copy of                            the functions of the agency, including
                                                                                                                            the draft supporting statement is                               whether the information will have


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                                                11362                            Federal Register / Vol. 82, No. 34 / Wednesday, February 22, 2017 / Notices

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

                                                                                                                                                                                                            Average
                                                                                                                                                                       Number of
                                                                                                                                                                                           Total            burden      Estimated
                                                                                                                                                                        responses
                                                      Data collection instrument                                     Type of respondents                                                  annual              per        burden
                                                                                                                                                                           per           response          response       hours
                                                                                                                                                                       respondent                           (hours)

                                                Community Health Assessment ........                     Individuals ........................................                       1              469          25/60          195

                                                     Total ...........................................   ...........................................................                1              469          25/60          195



                                                  There are no direct costs to                                          received by the National Cancer                                  applications claiming priority to the
                                                respondents to report.                                                  Institute’s Technology Transfer Center                           aforementioned applications).
                                                  Dated: February 10, 2017.                                             on or before March 9, 2017 will be                                  The patent rights in these inventions
                                                Chris Buchanan,                                                         considered.                                                      have been assigned and/or exclusively
                                                Assistant Surgeon General, USPHS, Acting                                                                                                 licensed to the government of the
                                                                                                                        ADDRESSES:   Requests for copies of the                          United States of America.
                                                Director, Indian Health Service.                                        patent application, inquiries, and
                                                [FR Doc. 2017–03407 Filed 2–21–17; 8:45 am]                                                                                                 The prospective exclusive license
                                                                                                                        comments relating to the contemplated
                                                                                                                                                                                         territory may be worldwide and the
                                                BILLING CODE 4160–16–P                                                  Exclusive Patent License should be
                                                                                                                                                                                         field of use may be limited to ‘‘the
                                                                                                                        directed to: Jim Knabb, Ph.D.,
                                                                                                                                                                                         Development and commercialization of
                                                                                                                        Technology Transfer and Patent
                                                DEPARTMENT OF HEALTH AND                                                                                                                 the transcatheter arterial
                                                                                                                        Specialist, NCI Technology Transfer
                                                HUMAN SERVICES                                                                                                                           chemoembolization (TACE) gene
                                                                                                                        Center, 9609 Medical Center Drive, RM
                                                                                                                                                                                         signature as a diagnostic device
                                                                                                                        1E530 MSC 9702, Bethesda, MD 20892–
                                                National Institutes of Health                                                                                                            predictive of TACE response in patients
                                                                                                                        9702 (for business mail), Rockville, MD
                                                                                                                                                                                         with hepatocellular carcinoma (HCC).
                                                Prospective Grant of Exclusive Patent                                   20850–9702; Telephone: (240) 276–
                                                                                                                                                                                         The field of use may be further limited
                                                License: Development of a Gene                                          5530; Facsimile: (240) 276–5504; Email:
                                                                                                                                                                                         to companion diagnostic tests that are
                                                Signature Predictive of Hepatocellular                                  jim.knabb@nih.gov.
                                                                                                                                                                                         sold following Premarket Approval by
                                                Carcinoma (HCC) Patient Response to                                     SUPPLEMENTARY INFORMATION:                                       the FDA or equivalent regulatory agency
                                                Transcatheter Arterial                                                                                                                   in foreign jurisdictions’’.
                                                Chemoembolization (TACE)                                                Intellectual Property
                                                                                                                                                                                            This technology discloses a gene
                                                AGENCY:      National Institutes of Health,                               United States Provisional Patent                               expression signature that is predictive of
                                                HHS.                                                                    Application No. 62/292,789, filed                                HCC patient response to TACE. TACE
                                                ACTION:     Notice.                                                     February 8, 2016 entitled ‘‘Gene                                 therapy is a procedure whereby the
                                                                                                                        Signature Predictive of Hepatocellular                           tumor is targeted with both local
                                                SUMMARY:   The National Cancer Institute,                               Carcinoma Response to Transcatheter                              chemotherapy and restriction of local
                                                an institute of the National Institutes of                              Arterial Chemoembolization’’ [HHS                                blood supply, and is employed in the
                                                Health, Department of Health and                                        Reference No. E–101–2016/0–US–01];                               treatment of locally advanced
                                                Human Services, is contemplating the                                    PCT Patent Application PCT/US2017/                               hepatocellular carcinoma (HCC). Patient
                                                grant of an Exclusive Patent License to                                 016851, filed February 7, 2017 and                               biopsies are analyzed by Next-
sradovich on DSK3GMQ082PROD with NOTICES




                                                practice the inventions embodied in the                                 entitled ‘‘GENE SIGNATURE                                        Generation Sequencing (NGS) and
                                                Patents and Patent Applications listed                                  PREDICTIVE OF HEPATOCELLULAR                                     expression analysis of the gene
                                                in the SUPPLEMENTARY INFORMATION                                        CARCINOMA RESPONSE TO                                            signature can be used to stratify patients
                                                section of this notice to 3D Medicines                                  TRANSCATHETER ARTERIAL                                           for TACE therapy. Through the
                                                (‘‘3DMed’’) located in Shanghai, China.                                 CHEMOEMBOLIZATION (TACE)’’                                       commercialization of this gene signature
                                                DATES: Only written comments and/or                                     [HHS Reference No. E–101–2016/0–                                 for TACE efficacy, HCC patients can be
                                                applications for a license which are                                    PCT–02]; (and U.S. and foreign patent                            identified as candidates for TACE


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Document Created: 2017-02-22 00:08:49
Document Modified: 2017-02-22 00:08:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice and request for comments.
DatesApril 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.
FR Citation82 FR 11361 

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