Agency Information Collection Activities: Proposed Collection: Public Comment Request, 31051-31052 [2015-13088]

Download as PDF Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices principles in the International Conference on Harmonisation (ICH) Q9, and knowledge management as defined in ICH Q10) by the regulated industry. This will also provide the FDA pathways to better regulate postapproval changes by utilizing more flexibility and risk-based principles, as envisioned by the pharmaceutical product quality initiatives laid out in FDA’s ‘‘Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century—A Risk Based Approach’’ (see http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/ Manufacturing/QuestionsandAnswerson CurrentGoodManufacturingPracticesc GMPforDrugs/UCM071836). This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Lhorne on DSK2VPTVN1PROD with NOTICES III. Paperwork Reduction Act This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 211, 314, and 601 have been approved under OMB control numbers 0910–0139, 0910–0001, and 0910–0338, respectively. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 Information/default.htm, or http:// www.regulations.gov. Dated: May 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–13104 Filed 5–29–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than July 31, 2015. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 594–4306. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Rural Outreach Benefits Counseling Program Measures OMB No. 0915– XXXX—New. Abstract: The Rural Outreach Benefits Counseling Program (Benefits Counseling Program) is authorized by section 330A(e) of the Public Health Service (PHS) Act (42 U.S.C. 254c(e)), as SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 31051 amended, to ‘‘promote rural health care services outreach by expanding the delivery of health care services to include new and enhanced services in rural areas.’’ The purpose of the 3-year Benefits Counseling Program is to expand outreach, education, and enrollment efforts to eligible uninsured and newly insured individuals and families in rural communities. The overarching goals of this grant funding are to coordinate and conduct innovative outreach activities through a strong consortium in order to: (1) Identify and enroll uninsured individuals and families who are eligible for public health insurance, such as Medicare, Medicaid, and the Children’s Health Insurance Program, and qualified health plans offered through Health Insurance Marketplaces and/or private health insurance plans in rural communities and (2) educate the newly insured individuals and families in rural communities about their health insurance benefits, help connect them to primary care and preventive services to which they now have access, and help them retain their health insurance coverage. Need and Proposed Use of the Information: For this program, performance measures were drafted to provide data to the program and to enable HRSA to provide aggregate program data required by Congress under the Government Performance and Results Act (GPRA) of 1993. These measures cover the principal topic areas of interest to the Federal Office of Rural Health Policy (FORHP), including: (a) Access to care; (b) population demographics; (c) staffing; (d) consortium/network; (e) sustainability; and (f) benefits counseling process and outcomes. Several measures will be used for the Benefits Counseling Program. All measures will speak to FORHP’s progress toward meeting the goals set. Likely Respondents: The respondents will be recipients of the Rural Outreach Benefits Counseling Program grant funding. 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 E:\FR\FM\01JNN1.SGM 01JNN1 31052 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. Number of respondents Form name Number of responses per respondent Total Estimated Annualized burden hours: Total responses Average urden per response in hours) Total burden hours Rural Outreach Benefits Counseling Grant Program Measures ................................................................................... 10 1 10 1.5 15 Total .............................................................................. 10 1 10 1.5 15 HRSA specifically requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015–13088 Filed 5–29–15; 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. ACTION: Notice. AGENCY: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Ryan Asherin, Oregon Health Authority: Based on the report of an investigation conducted by the Oregon Health Authority (OHA) and analysis conducted by ORI in its oversight review, ORI found that Ryan Asherin, former Surveillance Officer and Principal Investigator, OHA, Public Health Division engaged in research misconduct in research supported by the Centers for Disease Control and Prevention (CDC) Emerging Infections Program Grant 5U01CI00306–05. ORI found that the Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in the CDC research record, a manuscript submitted to JAMA Intern Med in January 2013, a published CDC report (CDC Morbidity and Mortality Weekly Report 61(09):157– 162, March 2012), and presentations in Lhorne on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 2012 to CDC and at the 11th Biennial Congress of the Anaerobe Society. ORI found that the Respondent falsified and/or fabricated fifty-six (56) case report forms (CRFs) while acquiring data on the incidence of Clostridium difficile infections in Klamath County, Oregon. Specifically, the Respondent (1) fabricated responses to multiple questions on the CRFs for patient demographic data, patient health information, and Clostridium difficile infection data, including the diagnoses of toxic megacolon and ileus and the performance of a colectomy, with no evidence in patient medical records to support the responses; and (2) falsified the CRFs by omitting data on the CRFs that clearly were included in patient medical records. Mr. Asherin has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of two (2) years, beginning on May 12, 2015: including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. (1) To have his research supervised; Respondent agrees that prior to submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent’s duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agrees that he will not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that any institution employing him must 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 himself voluntarily from serving in any advisory capacity to PHS SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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. 2015–13054 Filed 5–29–15; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the 2015 Hurricane Sandy Conference: Translating Research Into Practice Department of Health and Human Services, Office of the Secretary. ACTION: Notice. AGENCY: The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) is hereby giving notice that ASPR will convene a Hurricane Sandy Conference: Translating Research into Practice public meeting on August 10–11, 2015. The purpose of the meeting is to broadly share, with interested stakeholders, outcomes of Hurricane Sandy recovery science research and training projects awarded under ASPR FOAs EP–HIT– 13–001 and EP–HIT–14–001, Centers for Disease Control and Prevention (CDC) FOAs TP13–001 and OH13–002, and National Institute of Environmental Health Sciences (NIEHS) FOAs RFA– ES–13–008 and NOT–ES–13–003. Meeting participants will discuss opportunities to build a community of practice around Hurricane Sandy recovery research and the path forward for translating Hurricane Sandy recovery science research results into practice; highlight Hurricane Sandy recovery science grants as a model for disaster research science preparedness; and demonstrate the benefit of E:\FR\FM\01JNN1.SGM 01JNN1

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[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31051-31052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (HRSA) announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks 
comments from the public regarding the burden estimate, below, or any 
other aspect of the ICR.

DATES: Comments on this Information Collection Request must be received 
no later than July 31, 2015.

ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA 
Information Collection Clearance Officer, Room 10-29, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email paperwork@hrsa.gov or call the HRSA 
Information Collection Clearance Officer at (301) 594-4306.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Rural Outreach Benefits 
Counseling Program Measures OMB No. 0915-XXXX--New.
    Abstract: The Rural Outreach Benefits Counseling Program (Benefits 
Counseling Program) is authorized by section 330A(e) of the Public 
Health Service (PHS) Act (42 U.S.C. 254c(e)), as amended, to ``promote 
rural health care services outreach by expanding the delivery of health 
care services to include new and enhanced services in rural areas.'' 
The purpose of the 3-year Benefits Counseling Program is to expand 
outreach, education, and enrollment efforts to eligible uninsured and 
newly insured individuals and families in rural communities.
    The overarching goals of this grant funding are to coordinate and 
conduct innovative outreach activities through a strong consortium in 
order to: (1) Identify and enroll uninsured individuals and families 
who are eligible for public health insurance, such as Medicare, 
Medicaid, and the Children's Health Insurance Program, and qualified 
health plans offered through Health Insurance Marketplaces and/or 
private health insurance plans in rural communities and (2) educate the 
newly insured individuals and families in rural communities about their 
health insurance benefits, help connect them to primary care and 
preventive services to which they now have access, and help them retain 
their health insurance coverage.
    Need and Proposed Use of the Information: For this program, 
performance measures were drafted to provide data to the program and to 
enable HRSA to provide aggregate program data required by Congress 
under the Government Performance and Results Act (GPRA) of 1993. These 
measures cover the principal topic areas of interest to the Federal 
Office of Rural Health Policy (FORHP), including: (a) Access to care; 
(b) population demographics; (c) staffing; (d) consortium/network; (e) 
sustainability; and (f) benefits counseling process and outcomes. 
Several measures will be used for the Benefits Counseling Program. All 
measures will speak to FORHP's progress toward meeting the goals set.
    Likely Respondents: The respondents will be recipients of the Rural 
Outreach Benefits Counseling Program grant funding.
    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

[[Page 31052]]

the collection of information; and to transmit or otherwise disclose 
the information. The total annual burden hours estimated for this 
Information Collection Request are summarized in the table below.
    Total Estimated Annualized burden hours:

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Rural Outreach Benefits                       10               1              10             1.5              15
 Counseling Grant Program
 Measures.......................
                                 -------------------------------------------------------------------------------
    Total.......................              10               1              10             1.5              15
----------------------------------------------------------------------------------------------------------------

    HRSA specifically requests comments on: (1) The necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions; (2) the accuracy of the 
estimated burden; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-13088 Filed 5-29-15; 8:45 am]
 BILLING CODE 4165-15-P