Statement of Organization, Functions and Delegations of Authority, 66545-66546 [2015-27592]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices interested in assessing potential trial participants’ interest, tolerance, concerns, and willingness to participate in clinical investigations that involve nontraditional settings or utilize new technologies. FDA is also interested in identifying the factors that affect trial participant awareness, acceptance, enrollment, and retention for these investigations. a. Are there specific patient groups or therapeutic areas that could particularly benefit from these types of technologies or methods? b. What new opportunities for the conduct of clinical investigations are created through the use of continuous or intermittent remote monitoring and data collection? c. What are some of the anticipated risks to trial participants that may occur as a result of the use of these technologies or off-site methods in clinical investigations? d. What are some of the anticipated benefits to trial participants that may occur as a result of the use of these technologies or off-site methods in clinical investigations? e. Are there perceived challenges to participation in clinical investigations utilizing these types of technologies or methods because of concerns regarding inadvertent disclosure of trial participants’ information or breach of privacy? Are there concerns relating to the integrity of data collection or encryption or the secure transmission of information? f. Are there unique considerations for ensuring integrity of the source data, for example, authenticity and reliability? g. How should validation of participant-operated mobile devices be addressed? h. What are the challenges presented when data are collected using the Bring Your Own Device (BYOD) model? BYOD in clinical investigations refers to the practice of trial participants using their own devices, such as smartphones or tablets, for data collection. For example, participants in a clinical investigation may use their own computer devices to access and respond to study-related questionnaires. What are the perceived barriers to pooling data collected from different devices provided by individual trial participants, as well as pooling data from the BYOD model with data collected at the investigational site or on paper forms? How should situations such as mid-study user device switches be handled? i. What are the challenges or special considerations with recruiting and/or retaining potential trial participants with low levels of computer literacy or VerDate Sep<11>2014 23:37 Oct 28, 2015 Jkt 238001 individuals who may have limited or no access to mobile technologies, computer devices, or the Internet? How can these challenges or special considerations best be addressed? Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27581 Filed 10–28–15; 8:45 am] 66545 Dated: October 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27557 Filed 10–28–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4164–01–P Health Resources and Services Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES Statement of Organization, Functions and Delegations of Authority Food and Drug Administration 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. [Docket No. FDA–2014–D–2138] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUMMARY: On August 4, 2015, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0800. The approval expires on September 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at http:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 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 E:\FR\FM\29OCN1.SGM 29OCN1 66546 Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices 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 redelegations 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Dr. Maria C.P. Geraedts, University of Maryland, Baltimore: Based on the report of an investigation conducted by the University of Maryland, Baltimore (UMB) and analysis conducted by ORI in its oversight review, ORI and UMB found that Dr. Maria C.P. Geraedts, former postdoctoral fellow, Department asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 23:37 Oct 28, 2015 Jkt 238001 of Anatomy and Neurobiology, UMB, engaged in research misconduct in research supported by National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), grant R01 DC010110. ORI found falsified and/or fabricated data included in the following two (2) publications: • Am J Physiol Endocrinol Metab 303:E464–E474, 2012 (hereafter referred to as ‘‘AJP 2012’’) • Journal of Neuroscience 33(17):7559–7564, 2013 (hereafter referred to as ‘‘JN 2013’’) As a result of the UMB investigation, JN 2013 and AJP 2012 have been retracted. ORI found that Respondent falsified and/or fabricated bar graphs in AJP 2012, by changing ELISA-based measurements to produce the desired result for secretion of glucagon-like peptide-1 (GLP–1) from intestinal explants from various mouse strains in: • Figure 2 for GLP–1 release from duodenum (2A & D), jejunum (2B & E), and ileum (2C & F). • Figure 3 for GLP–1 release from colon (3A & C) and rectum (3D). • Figure 4 for GLP–1 release from ileum (4A) and colon (4C) in the presence or absence of an ATP-sensitive K+ channel inhibitor. ORI found that Respondent falsified and/or fabricated bar graphs in Figure 1, JN 2013 by changing ELISA-based measurements to produce the desired result for the secretion of peptides found in taste buds (GLP–1, glucagon, or neuropeptide Y) from mouse lingual epithelium exposed to various concentrations of stimuli (glucose, sucralose, MSG, polycose). These bar graphs also were included as Figure 7 in grant application R01 DC010110–06. Both the Respondent and the U.S. Department of Health and Human Services (HHS) want to conclude this matter without further expenditure of time or other resources and have entered into a Voluntary Settlement Agreement (Agreement) to resolve this matter. Respondent stated that she is not currently involved in U.S. Public Health Service (PHS)-supported research and has no intention of applying for or engaging in PHS-supported research or otherwise working with PHS. Dr. Geraedts has entered into a Voluntary Settlement Agreement with ORI and UMB, in which she voluntarily agreed to the administrative actions set forth below. The administrative actions are required for three (3) years beginning on the date of Dr. Geraedts employment in a position in which she receives or applies for PHS support on or after the effective date of the Agreement PO 00000 Frm 00059 Fmt 4703 Sfmt 9990 (September 22, 2015). If the Respondent has not obtained employment in a research position in which she receives or applies for PHS support within one (1) year of the effective date of the Agreement, the administrative actions set forth below will no longer apply. Dr. Geraedts has voluntarily agreed: (1) To have her research supervised as described below and notify her employer(s)/institution(s) of the terms of this supervision; Respondent agreed that prior to the submission of an application for PHS support for a research project on which her participation is proposed and prior to her participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of her research contribution; Respondent agreed that she will not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that any institution employing her shall submit in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHSsupported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) to exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for period of three (3) years beginning on September 22, 2015. FOR FURTHER INFORMATION CONTACT: Acting Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453– 8200. Donald Wright, Acting Director, Office of Research Integrity. [FR Doc. 2015–27587 Filed 10–28–15; 8:45 am] BILLING CODE 4150–31–P E:\FR\FM\29OCN1.SGM 29OCN1

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[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66545-66546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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