80_FR_66754 80 FR 66545 - Statement of Organization, Functions and Delegations of Authority

80 FR 66545 - Statement of Organization, Functions and Delegations of Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 80, Issue 209 (October 29, 2015)

Page Range66545-66546
FR Document2015-27592

Federal Register, Volume 80 Issue 209 (Thursday, October 29, 2015) 
[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66545-66546]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Statement of Organization, Functions and Delegations of Authority

    This notice amends Part R of the Statement of Organization, 
Functions and Delegations of Authority of the Department of Health and 
Human Services (HHS), Health Resources and Services Administration 
(HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 80 
FR 44358 dated July 27, 2015).
    This notice reflects organizational changes in the Health Resources 
and Services Administration (HRSA), Office of Planning, Analysis, and 
Evaluation (RA5). Specifically, this notice: (1) Establishes the Office 
of Strategic Initiatives (RA59) within the Office of Planning, 
Analysis, and Evaluation.

Chapter RA5--Office of Planning, Analysis, and Evaluation

Section RA5--00, Mission

    The Office of Planning, Analysis, and Evaluation (RA5) provide 
HRSA-wide leadership on cross-agency initiatives and Departmental 
priorities.

Section RA5-10, Organization

    Delete the organization for the Office of Planning, Analysis, and 
Evaluation in its entirety and replace with the following:
    The Office of Planning, Analysis, and Evaluation (RA5) is headed by 
the Director, who reports directly to the Administrator, Health 
Resources and Services Administration. The Office of Planning, 
Analysis, and Evaluation includes the following components:
    (1) Office of the Director (RA5);
    (2) Office of Policy Analysis (RA53);
    (3) Office of Research and Evaluation (RA56);
    (4) Office of External Engagement (RA57);
    (5) Office of Performance and Quality Measurement (RA58); and
    (6) Office of Strategic Initiatives (RA59).

Section RA5-20, Functions

    This notice reflects organizational changes in the Health Resources 
and Services Administration (HRSA), Office

[[Page 66546]]

of Planning, Analysis, and Evaluation (RA5). Specifically, this notice: 
(1) Establishes the Office of Strategic Initiatives (RA59).
    Establish the functional statement for the Office of Strategic 
Initiatives (RA59) within the Office of Planning, Analysis, and 
Evaluation (RA5).

Office of Strategic Initiatives (RA59)

    (1) Provides HRSA-wide leadership on cross-agency initiatives and 
departmental priorities; (2) maintains liaison between the 
Administrator, other OPDIVs, Office of the Secretary staff components, 
and other Departments on priority initiatives; (3) provides technical 
assistance to Agency programs in order to help them respond to emerging 
issues affecting the health care safety net; (4) coordinates outreach 
to grantees and stakeholders on high profile public health initiatives; 
(5) establishes an infrastructure and strategic direction of priority 
initiatives and institutionalizes these efforts into HRSA programs; and 
(6) coordinates the Agency's long-term strategic planning process.

Delegations of Authority

    All delegations of authority and re-delegations of authority made 
to HRSA officials that were in effect immediately prior to this 
reorganization, and that are consistent with this reorganization, shall 
continue in effect pending further re-delegation.
    This reorganization is effective upon date of signature.

    Dated: October 18, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015-27592 Filed 10-28-15; 8:45 am]
 BILLING CODE 4165-15-P

Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices 66545 interested in assessing potential trial individuals who may have limited or no Dated: October 23, 2015. participants’ interest, tolerance, access to mobile technologies, computer Leslie Kux, concerns, and willingness to participate devices, or the Internet? How can these Associate Commissioner for Policy. in clinical investigations that involve challenges or special considerations best [FR Doc. 2015–27557 Filed 10–28–15; 8:45 am] nontraditional settings or utilize new be addressed? BILLING CODE 4164–01–P technologies. FDA is also interested in Dated: October 26, 2015. identifying the factors that affect trial Leslie Kux, participant awareness, acceptance, DEPARTMENT OF HEALTH AND Associate Commissioner for Policy. enrollment, and retention for these HUMAN SERVICES investigations. [FR Doc. 2015–27581 Filed 10–28–15; 8:45 am] a. Are there specific patient groups or BILLING CODE 4164–01–P Health Resources and Services therapeutic areas that could particularly Administration benefit from these types of technologies or methods? DEPARTMENT OF HEALTH AND Statement of Organization, Functions b. What new opportunities for the HUMAN SERVICES and Delegations of Authority conduct of clinical investigations are Food and Drug Administration This notice amends Part R of the created through the use of continuous or Statement of Organization, Functions intermittent remote monitoring and data [Docket No. FDA–2014–D–2138] and Delegations of Authority of the collection? c. What are some of the anticipated Department of Health and Human risks to trial participants that may occur Agency Information Collection Services (HHS), Health Resources and as a result of the use of these Activities; Announcement of Office of Services Administration (HRSA) (60 FR technologies or off-site methods in Management and Budget Approval; 56605, as amended November 6, 1995; clinical investigations? Guidance for Industry on Adverse as last amended at 80 FR 44358 dated d. What are some of the anticipated Event Reporting for Outsourcing July 27, 2015). benefits to trial participants that may Facilities This notice reflects organizational occur as a result of the use of these changes in the Health Resources and AGENCY: Food and Drug Administration, Services Administration (HRSA), Office technologies or off-site methods in HHS. of Planning, Analysis, and Evaluation clinical investigations? e. Are there perceived challenges to ACTION: Notice. (RA5). Specifically, this notice: (1) participation in clinical investigations Establishes the Office of Strategic utilizing these types of technologies or SUMMARY: The Food and Drug Initiatives (RA59) within the Office of methods because of concerns regarding Administration (FDA) is announcing Planning, Analysis, and Evaluation. inadvertent disclosure of trial that a collection of information entitled Chapter RA5—Office of Planning, participants’ information or breach of ‘‘Guidance for Industry on Adverse Analysis, and Evaluation privacy? Are there concerns relating to Event Reporting for Outsourcing the integrity of data collection or Facilities Under Section 503B of the Section RA5—00, Mission encryption or the secure transmission of Federal Food, Drug and Cosmetic Act’’ The Office of Planning, Analysis, and information? has been approved by the Office of Evaluation (RA5) provide HRSA-wide f. Are there unique considerations for Management and Budget (OMB) under leadership on cross-agency initiatives ensuring integrity of the source data, for the Paperwork Reduction Act of 1995. and Departmental priorities. example, authenticity and reliability? FOR FURTHER INFORMATION CONTACT: FDA g. How should validation of Section RA5–10, Organization PRA Staff, Office of Operations, Food participant-operated mobile devices be and Drug Administration, 8455 Delete the organization for the Office addressed? Colesville Rd., COLE–14526, Silver of Planning, Analysis, and Evaluation in h. What are the challenges presented Spring, MD 20993–0002, PRAStaff@ its entirety and replace with the when data are collected using the Bring fda.hhs.gov. following: Your Own Device (BYOD) model? The Office of Planning, Analysis, and BYOD in clinical investigations refers to SUPPLEMENTARY INFORMATION: On August Evaluation (RA5) is headed by the the practice of trial participants using 4, 2015, the Agency submitted a Director, who reports directly to the their own devices, such as smartphones proposed collection of information Administrator, Health Resources and or tablets, for data collection. For entitled ‘‘Guidance for Industry on Services Administration. The Office of example, participants in a clinical Adverse Event Reporting for Planning, Analysis, and Evaluation investigation may use their own Outsourcing Facilities Under Section includes the following components: computer devices to access and respond 503B of the Federal Food, Drug, and (1) Office of the Director (RA5); to study-related questionnaires. What Cosmetic Act’’ to OMB for review and (2) Office of Policy Analysis (RA53); are the perceived barriers to pooling clearance under 44 U.S.C. 3507. An (3) Office of Research and Evaluation data collected from different devices Agency may not conduct or sponsor, (RA56); provided by individual trial and a person is not required to respond (4) Office of External Engagement participants, as well as pooling data to, a collection of information unless it (RA57); from the BYOD model with data displays a currently valid OMB control asabaliauskas on DSK5VPTVN1PROD with NOTICES (5) Office of Performance and Quality collected at the investigational site or on number. OMB has now approved the Measurement (RA58); and paper forms? How should situations information collection and has assigned (6) Office of Strategic Initiatives such as mid-study user device switches OMB control number 0910–0800. The (RA59). be handled? approval expires on September 30, i. What are the challenges or special 2018. A copy of the supporting Section RA5–20, Functions considerations with recruiting and/or statement for this information collection This notice reflects organizational retaining potential trial participants is available on the Internet at http:// changes in the Health Resources and with low levels of computer literacy or www.reginfo.gov/public/do/PRAMain. Services Administration (HRSA), Office VerDate Sep<11>2014 23:37 Oct 28, 2015 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\29OCN1.SGM 29OCN1

66546 Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices of Planning, Analysis, and Evaluation of Anatomy and Neurobiology, UMB, (September 22, 2015). If the Respondent (RA5). Specifically, this notice: (1) engaged in research misconduct in has not obtained employment in a Establishes the Office of Strategic research supported by National Institute research position in which she receives Initiatives (RA59). on Deafness and Other Communication or applies for PHS support within one Establish the functional statement for Disorders (NIDCD), National Institutes (1) year of the effective date of the the Office of Strategic Initiatives (RA59) of Health (NIH), grant R01 DC010110. Agreement, the administrative actions within the Office of Planning, Analysis, ORI found falsified and/or fabricated set forth below will no longer apply. Dr. and Evaluation (RA5). data included in the following two (2) Geraedts has voluntarily agreed: publications: Office of Strategic Initiatives (RA59) • Am J Physiol Endocrinol Metab (1) To have her research supervised as (1) Provides HRSA-wide leadership 303:E464–E474, 2012 (hereafter referred described below and notify her on cross-agency initiatives and to as ‘‘AJP 2012’’) employer(s)/institution(s) of the terms of departmental priorities; (2) maintains • Journal of Neuroscience this supervision; Respondent agreed liaison between the Administrator, other 33(17):7559–7564, 2013 (hereafter that prior to the submission of an OPDIVs, Office of the Secretary staff referred to as ‘‘JN 2013’’) application for PHS support for a components, and other Departments on As a result of the UMB investigation, research project on which her priority initiatives; (3) provides JN 2013 and AJP 2012 have been participation is proposed and prior to technical assistance to Agency programs retracted. her participation in any capacity on in order to help them respond to ORI found that Respondent falsified PHS-supported research, Respondent emerging issues affecting the health care and/or fabricated bar graphs in AJP shall ensure that a plan for supervision safety net; (4) coordinates outreach to 2012, by changing ELISA-based of her duties is submitted to ORI for grantees and stakeholders on high measurements to produce the desired approval; the supervision plan must be profile public health initiatives; (5) result for secretion of glucagon-like designed to ensure the scientific establishes an infrastructure and peptide-1 (GLP–1) from intestinal explants from various mouse strains in: integrity of her research contribution; strategic direction of priority initiatives Respondent agreed that she will not and institutionalizes these efforts into • Figure 2 for GLP–1 release from duodenum (2A & D), jejunum (2B & E), participate in any PHS-supported HRSA programs; and (6) coordinates the and ileum (2C & F). research until such a supervision plan is Agency’s long-term strategic planning process. • Figure 3 for GLP–1 release from submitted to and approved by ORI; colon (3A & C) and rectum (3D). Respondent agreed to maintain Delegations of Authority • Figure 4 for GLP–1 release from responsibility for compliance with the All delegations of authority and re- ileum (4A) and colon (4C) in the agreed upon supervision plan; delegations of authority made to HRSA presence or absence of an ATP-sensitive (2) that any institution employing her officials that were in effect immediately K+ channel inhibitor. shall submit in conjunction with each prior to this reorganization, and that are ORI found that Respondent falsified and/or fabricated bar graphs in Figure 1, application for PHS funds, or report, consistent with this reorganization, manuscript, or abstract involving PHS- shall continue in effect pending further JN 2013 by changing ELISA-based measurements to produce the desired supported research in which re-delegation. Respondent is involved, a certification This reorganization is effective upon result for the secretion of peptides found in taste buds (GLP–1, glucagon, or to ORI that the data provided by date of signature. Respondent are based on actual neuropeptide Y) from mouse lingual Dated: October 18, 2015. epithelium exposed to various experiments or are otherwise James Macrae, concentrations of stimuli (glucose, legitimately derived, and that the data, Acting Administrator. sucralose, MSG, polycose). These bar procedures, and methodology are [FR Doc. 2015–27592 Filed 10–28–15; 8:45 am] graphs also were included as Figure 7 in accurately reported in the application, BILLING CODE 4165–15–P grant application R01 DC010110–06. report, manuscript, or abstract; and Both the Respondent and the U.S. (3) to exclude herself voluntarily from Department of Health and Human serving in any advisory capacity to PHS DEPARTMENT OF HEALTH AND Services (HHS) want to conclude this including, but not limited to, service on HUMAN SERVICES matter without further expenditure of any PHS advisory committee, board, time or other resources and have Office of the Secretary and/or peer review committee, or as a entered into a Voluntary Settlement Agreement (Agreement) to resolve this consultant for period of three (3) years Findings of Research Misconduct matter. Respondent stated that she is not beginning on September 22, 2015. AGENCY: Office of the Secretary, HHS. currently involved in U.S. Public Health FOR FURTHER INFORMATION CONTACT: ACTION: Notice. Service (PHS)-supported research and Acting Director, Office of Research has no intention of applying for or Integrity, 1101 Wootton Parkway, Suite SUMMARY: Notice is hereby given that engaging in PHS-supported research or 750, Rockville, MD 20852, (240) 453– the Office of Research Integrity (ORI) otherwise working with PHS. Dr. 8200. has taken final action in the following Geraedts has entered into a Voluntary case: Settlement Agreement with ORI and Donald Wright, asabaliauskas on DSK5VPTVN1PROD with NOTICES Dr. Maria C.P. Geraedts, University of UMB, in which she voluntarily agreed Acting Director, Office of Research Integrity. Maryland, Baltimore: Based on the to the administrative actions set forth [FR Doc. 2015–27587 Filed 10–28–15; 8:45 am] report of an investigation conducted by below. The administrative actions are BILLING CODE 4150–31–P the University of Maryland, Baltimore required for three (3) years beginning on (UMB) and analysis conducted by ORI the date of Dr. Geraedts employment in in its oversight review, ORI and UMB a position in which she receives or found that Dr. Maria C.P. Geraedts, applies for PHS support on or after the former postdoctoral fellow, Department effective date of the Agreement VerDate Sep<11>2014 23:37 Oct 28, 2015 Jkt 238001 PO 00000 Frm 00059 Fmt 4703 Sfmt 9990 E:\FR\FM\29OCN1.SGM 29OCN1


Document Created: 2015-12-14 15:21:51
Document Modified: 2015-12-14 15:21:51
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
FR Citation80 FR 66545 
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