80 FR 31051 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 104 (June 1, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 104 (June 1, 2015)
| Page Range | 31051-31052 | |
| FR Document | 2015-13088 |
[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)] [Notices] [Pages 31051-31052] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-13088] ----------------------------------------------------------------------- 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
![Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices 31051
principles in the International Information/default.htm, or http:// amended, to ‘‘promote rural health care
Conference on Harmonisation (ICH) Q9, www.regulations.gov. services outreach by expanding the
and knowledge management as defined Dated: May 26, 2015. delivery of health care services to
in ICH Q10) by the regulated industry. Leslie Kux,
include new and enhanced services in
This will also provide the FDA rural areas.’’ The purpose of the 3-year
Associate Commissioner for Policy.
pathways to better regulate postapproval Benefits Counseling Program is to
changes by utilizing more flexibility and [FR Doc. 2015–13104 Filed 5–29–15; 8:45 am] expand outreach, education, and
risk-based principles, as envisioned by BILLING CODE 4164–01–P enrollment efforts to eligible uninsured
the pharmaceutical product quality and newly insured individuals and
initiatives laid out in FDA’s families in rural communities.
‘‘Pharmaceutical Current Good DEPARTMENT OF HEALTH AND The overarching goals of this grant
Manufacturing Practices (cGMPs) for the HUMAN SERVICES funding are to coordinate and conduct
21st Century—A Risk Based Approach’’ innovative outreach activities through a
Health Resources and Services
(see http://www.fda.gov/Drugs/ strong consortium in order to: (1)
Administration
DevelopmentApprovalProcess/ Identify and enroll uninsured
Manufacturing/QuestionsandAnswerson Agency Information Collection individuals and families who are
CurrentGoodManufacturingPracticesc Activities: Proposed Collection: Public eligible for public health insurance,
GMPforDrugs/UCM071836). Comment Request such as Medicare, Medicaid, and the
This draft guidance is being issued Children’s Health Insurance Program,
consistent with FDA’s good guidance AGENCY: Health Resources and Services and qualified health plans offered
practices regulation (21 CFR 10.115). Administration, HHS. through Health Insurance Marketplaces
The draft guidance, when finalized, will ACTION: Notice. and/or private health insurance plans in
represent the current thinking of FDA rural communities and (2) educate the
on ‘‘Established Conditions: Reportable SUMMARY: In compliance with the newly insured individuals and families
CMC Changes for Approved Drug and requirement for opportunity for public in rural communities about their health
Biologic Products.’’ It does not establish comment on proposed data collection insurance benefits, help connect them to
any rights for any person and is not projects (section 3506(c)(2)(A) of the primary care and preventive services to
binding on FDA or the public. You can Paperwork Reduction Act of 1995), the which they now have access, and help
use an alternative approach if it satisfies Health Resources and Services them retain their health insurance
the requirements of the applicable Administration (HRSA) announces coverage.
statutes and regulations. plans to submit an Information Need and Proposed Use of the
Collection Request (ICR), described Information: For this program,
II. Comments below, to the Office of Management and performance measures were drafted to
Interested persons may submit either Budget (OMB). Prior to submitting the provide data to the program and to
electronic comments regarding this ICR to OMB, HRSA seeks comments enable HRSA to provide aggregate
document to http://www.regulations.gov from the public regarding the burden program data required by Congress
or written comments to the Division of estimate, below, or any other aspect of under the Government Performance and
Dockets Management (see ADDRESSES). It the ICR. Results Act (GPRA) of 1993. These
is only necessary to send one set of DATES: Comments on this Information measures cover the principal topic areas
comments. Identify comments with the Collection Request must be received no of interest to the Federal Office of Rural
docket number found in brackets in the later than July 31, 2015. Health Policy (FORHP), including: (a)
heading of this document. Received Access to care; (b) population
ADDRESSES: Submit your comments to
comments may be seen in the Division demographics; (c) staffing; (d)
paperwork@hrsa.gov or mail the HRSA
of Dockets Management between 9 a.m. consortium/network; (e) sustainability;
Information Collection Clearance
and 4 p.m., Monday through Friday, and and (f) benefits counseling process and
Officer, Room 10–29, Parklawn
will be posted to the docket at http:// outcomes. Several measures will be
Building, 5600 Fishers Lane, Rockville,
www.regulations.gov. used for the Benefits Counseling
MD 20857.
Program. All measures will speak to
III. Paperwork Reduction Act FOR FURTHER INFORMATION CONTACT: To FORHP’s progress toward meeting the
This guidance refers to previously request more information on the goals set.
approved collections of information that proposed project or to obtain a copy of Likely Respondents: The respondents
are subject to review by the Office of the data collection plans and draft will be recipients of the Rural Outreach
Management and Budget (OMB) under instruments, email paperwork@hrsa.gov Benefits Counseling Program grant
the Paperwork Reduction Act of 1995 or call the HRSA Information Collection funding.
(44 U.S.C. 3501–3520). The collections Clearance Officer at (301) 594–4306. Burden Statement: Burden in this
of information in 21 CFR parts 211, 314, SUPPLEMENTARY INFORMATION: When context means the time expended by
and 601 have been approved under submitting comments or requesting persons to generate, maintain, retain,
OMB control numbers 0910–0139, information, please include the disclose or provide the information
0910–0001, and 0910–0338, information request collection title for requested. This includes the time
respectively. reference. needed to review instructions; to
Information Collection Request Title: develop, acquire, install and utilize
IV. Electronic Access Rural Outreach Benefits Counseling technology and systems for the purpose
Lhorne on DSK2VPTVN1PROD with NOTICES
Persons with access to the Internet Program Measures OMB No. 0915– of collecting, validating and verifying
may obtain the document at either XXXX—New. information, processing and
http://www.fda.gov/Drugs/Guidance Abstract: The Rural Outreach Benefits maintaining information, and disclosing
ComplianceRegulatoryInformation/ Counseling Program (Benefits and providing information; to train
Guidances/default.htm, http:// Counseling Program) is authorized by personnel and to be able to respond to
www.fda.gov/BiologicsBloodVaccines/ section 330A(e) of the Public Health a collection of information; to search
GuidanceComplianceRegulatory Service (PHS) Act (42 U.S.C. 254c(e)), as data sources; to complete and review
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![31052 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices
the collection of information; and to hours estimated for this Information Total Estimated Annualized burden
transmit or otherwise disclose the Collection Request are summarized in hours:
information. The total annual burden the table below.
Average
Number of
Number of Total urden per Total burden
Form name responses per
respondents responses response hours
respondent in hours)
Rural Outreach Benefits Counseling Grant Program Meas-
ures ................................................................................... 10 1 10 1.5 15
Total .............................................................................. 10 1 10 1.5 15
HRSA specifically requests comments 2012 to CDC and at the 11th Biennial including, but not limited to, service on any
on: (1) The necessity and utility of the Congress of the Anaerobe Society. PHS advisory committee, board, and/or peer
proposed information collection for the ORI found that the Respondent review committee, or as a consultant.
proper performance of the agency’s falsified and/or fabricated fifty-six (56) FOR FURTHER INFORMATION CONTACT:
functions; (2) the accuracy of the case report forms (CRFs) while Acting Director, Office of Research
estimated burden; (3) ways to enhance acquiring data on the incidence of Integrity, 1101 Wootton Parkway, Suite
the quality, utility, and clarity of the Clostridium difficile infections in 750, Rockville, MD 20852, (240) 453–
information to be collected; and (4) the Klamath County, Oregon. Specifically, 8200.
use of automated collection techniques the Respondent (1) fabricated responses
to multiple questions on the CRFs for Donald Wright,
or other forms of information
technology to minimize the information patient demographic data, patient health Acting Director, Office of Research Integrity.
collection burden. information, and Clostridium difficile [FR Doc. 2015–13054 Filed 5–29–15; 8:45 am]
infection data, including the diagnoses BILLING CODE 4150–31–P
Jackie Painter, of toxic megacolon and ileus and the
Director, Division of the Executive Secretariat. performance of a colectomy, with no
[FR Doc. 2015–13088 Filed 5–29–15; 8:45 am] evidence in patient medical records to DEPARTMENT OF HEALTH AND
BILLING CODE 4165–15–P support the responses; and (2) falsified HUMAN SERVICES
the CRFs by omitting data on the CRFs
that clearly were included in patient Meeting of the 2015 Hurricane Sandy
DEPARTMENT OF HEALTH AND medical records. Conference: Translating Research Into
HUMAN SERVICES Mr. Asherin has entered into a Practice
Voluntary Settlement Agreement AGENCY: Department of Health and
Office of the Secretary (Agreement) and has voluntarily agreed Human Services, Office of the Secretary.
Findings of Research Misconduct for a period of two (2) years, beginning
ACTION: Notice.
on May 12, 2015:
AGENCY: Office of the Secretary, HHS. (1) To have his research supervised; SUMMARY: The Department of Health and
ACTION: Notice. Respondent agrees that prior to submission of Human Services (HHS) Office of the
an application for U.S. Public Health Service Assistant Secretary for Preparedness
SUMMARY: Notice is hereby given that (PHS) support for a research project on which
the Respondent’s participation is proposed and Response (ASPR) is hereby giving
the Office of Research Integrity (ORI) and prior to Respondent’s participation in notice that ASPR will convene a
has taken final action in the following any capacity on PHS-supported research, Hurricane Sandy Conference:
case: Respondent shall ensure that a plan for Translating Research into Practice
Ryan Asherin, Oregon Health supervision of Respondent’s duties is public meeting on August 10–11, 2015.
Authority: Based on the report of an submitted to ORI for approval; the The purpose of the meeting is to broadly
investigation conducted by the Oregon supervision plan must be designed to ensure share, with interested stakeholders,
Health Authority (OHA) and analysis the scientific integrity of Respondent’s
research contribution; Respondent agrees that
outcomes of Hurricane Sandy recovery
conducted by ORI in its oversight he will not participate in any PHS-supported science research and training projects
review, ORI found that Ryan Asherin, research until such a supervision plan is awarded under ASPR FOAs EP–HIT–
former Surveillance Officer and submitted to and approved by ORI; 13–001 and EP–HIT–14–001, Centers for
Principal Investigator, OHA, Public Respondent agrees to maintain responsibility Disease Control and Prevention (CDC)
Health Division engaged in research for compliance with the agreed upon FOAs TP13–001 and OH13–002, and
misconduct in research supported by supervision plan; National Institute of Environmental
the Centers for Disease Control and (2) that any institution employing him
must submit, in conjunction with each
Health Sciences (NIEHS) FOAs RFA–
Prevention (CDC) Emerging Infections application for PHS funds, or report, ES–13–008 and NOT–ES–13–003.
Program Grant 5U01CI00306–05. manuscript, or abstract involving PHS- Meeting participants will discuss
ORI found that the Respondent supported research in which Respondent is opportunities to build a community of
engaged in research misconduct by involved, a certification to ORI that the data practice around Hurricane Sandy
Lhorne on DSK2VPTVN1PROD with NOTICES
falsifying and/or fabricating data that provided by Respondent are based on actual recovery research and the path forward
were included in the CDC research experiments or are otherwise legitimately for translating Hurricane Sandy
record, a manuscript submitted to JAMA derived and that the data, procedures, and recovery science research results into
methodology are accurately reported in the
Intern Med in January 2013, a published application, report, manuscript, or abstract; practice; highlight Hurricane Sandy
CDC report (CDC Morbidity and and recovery science grants as a model for
Mortality Weekly Report 61(09):157– (3) to exclude himself voluntarily from disaster research science preparedness;
162, March 2012), and presentations in serving in any advisory capacity to PHS and demonstrate the benefit of
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Document Created: 2015-12-15 15:19:13
Document Modified: 2015-12-15 15:19:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this Information Collection Request must be received no later than July 31, 2015. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 594-4306. | |
| FR Citation | 80 FR 31051 |
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