Agency Information Collection Activities: Proposed Collection: Public Comment Request, 69694-69695 [2013-27798]

Download as PDF 69694 Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or http:// www.regulations.gov. Dated: November 14, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–27774 Filed 11–19–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate and Reward True PatientCentric Value in Innovation; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation.’’ FDA is cosponsoring the workshop with the American Gastroenterological Association (AGA). The purpose of the workshop is to facilitate discussion between FDA, AGA, and other interested parties of the development of medical devices for the treatment of morbid obesity and other metabolic diseases and evolving approaches for the regulation and reimbursement of minimally invasive procedures. The public workshop is being rescheduled due to the government shutdown. The title of the workshop has also been changed. DATES AMD TIMES: The public workshop will be held on December 19, 2013, from 8:30 a.m. to 5 p.m. and on December 20, 2013, from 8:30 a.m. to 12:15 p.m. Location: The public workshop will be held at the Grand Hyatt Washington, DC, 1000 H St. NW., Washington, DC 20001, 202–582–1234. Contact Person: Herbert Lerner, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:04 Nov 19, 2013 Jkt 232001 Rm. G114, Silver Spring, MD 20993– 0002, 301–796–6511, email: herbert.lerner@fda.hhs.gov. Registration: Registration is limited and is available on a first-come, firstserved basis. Persons interested in attending this public workshop must register online by 4 p.m. (EDT), December 10, 2013. Onsite registration will be available after this date. To register for the public workshop, please visit the American Gastroenterological Association (AGA) Web site: http:// www.gastro.org/education-meetings/ live-meetings/aga-fda-regulation-andreimbursement-workshop. For more information on the workshop, please see the FDA’s Medical Devices News & Events—Workshops & Conferences calendar at http://www.fda.gov/ MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) The AGA will collect a registration fee to cover its share of the expenses associated with the public workshop, which is included in the registration information on the AGA Web site. If you need special accommodations due to a disability, please contact Herbert Lerner (see Contact Person) at least 7 days before the public workshop. SUPPLEMENTARY INFORMATION: I. Background The purpose of the public workshop is to facilitate discussion between FDA, the AGA and other interested parties on the issues of device development, public and private payer reimbursement, venture capital, and regulatory pathways for device innovation and marketing. The workshop will provide a forum for discussing new approaches for the treatment of morbid obesity and other metabolic diseases as well as evolving approaches for the regulation and reimbursement of minimally invasive procedures. II. Topics for Discussion at the Public Workshop Topics to be discussed at the public workshop include, but are not limited to: • Challenges to MedTech Innovation in the United States; • Evolving Approaches for the Regulation of Minimally Invasive Procedures: The FDA Benefit/Risk Paradigm; • Evolving Approaches for the Reimbursement of Minimally Invasive Procedures: How to Put a Price on Value; PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 • Obesity as a Disease: Redefining the Regulatory and Reimbursement Context; and • The ‘‘Process’’—Investigational Device Exemption Review. Dated: November 14, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–27771 Filed 11–19–13; 8:45 am] BILLING CODE 4160–01–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 within 60 days of this notice. 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) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: The National Health Service Corps and NURSE Corps Interest Capture Form. OMB No.: 0915–0337—Revision. Abstract: The National Health Service Corps (NHSC) and the NURSE Corps of SUMMARY: E:\FR\FM\20NON1.SGM 20NON1 69695 Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices the Bureau of Clinician Recruitment and Service (BCRS), HRSA, are both committed to improving the health of the nation’s underserved by uniting communities in need with caring health professionals and by supporting communities’ efforts to build better systems of care. The NHSC and NURSE Corps Interest Capture Form, which will be used when exhibiting at national and regional conferences, as well as when presenting on campuses to health profession students, is an optional form that a health profession student, licensed clinician, faculty member, or clinical site administrator can fill out and submit to BCRS representatives at the recruitment event. The purpose of the form is to enable individuals and clinical sites to ask BCRS for periodic program updates and other general information regarding opportunities with the NHSC and/or the NURSE Corps via email. Completed forms will contain information such as the names of the individuals, their email address(es), their city and state, the organization where they are employed (or the school which they attend), the year they intend to graduate (if applicable), how they heard about the NHSC/NURSE Corps, and the programs in which they are interested. Assistance in completing the form will be given by the BCRS staff person (or BCRS representative) who is present at the event. Need and Proposed Use of the Information: The need and purpose of this information collection is to share resources and information regarding the NHSC and Nurse Corps programs with interested conference/event participants. Likely Respondents: Conference/event participants interested in the NHSC or Nurse Corps programs. 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 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 Number of respondents Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours NHSC and NURSE Corps Interest Capture Form .............. 2,400 1 2,400 .025 60 Total .............................................................................. 2,400 1 2,400 .025 60 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. Dated: November 13, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–27798 Filed 11–19–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES tkelley on DSK3SPTVN1PROD with NOTICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: VerDate Mar<15>2010 16:04 Nov 19, 2013 Jkt 232001 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 within 60 days of this notice. 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) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 information, please include the information request collection title for reference. Information Collection Request Title: Data System for Organ Procurement and Transplantation Network. OMB No. 0915–0184– Revision. Abstract: The operation of the Organ Procurement and Transplantation Network (OPTN) necessitates certain recordkeeping and reporting requirements in order to perform the functions related to organ transplantation under contract to HHS. This is a request for a revision of the current recordkeeping and reporting requirements associated with the OPTN membership application requirements. The proposed data collection includes information pertinent to OPTN membership eligibility and designation, transplant program eligibility requirements to receive organs for transplantation, and changes in OPTN transplant member personnel. These data will be used by HRSA in monitoring the contracts for the OPTN and the Scientific Registry of Transplant Recipients (SRTR) and in carrying out other statutory responsibilities. Need and Proposed Use of the Information: Information is needed to collect and review submission of application materials and determine E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69694-69695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27798]


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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.

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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 
within 60 days of this notice.

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) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: The National Health Service 
Corps and NURSE Corps Interest Capture Form.
    OMB No.: 0915-0337--Revision.
    Abstract: The National Health Service Corps (NHSC) and the NURSE 
Corps of

[[Page 69695]]

the Bureau of Clinician Recruitment and Service (BCRS), HRSA, are both 
committed to improving the health of the nation's underserved by 
uniting communities in need with caring health professionals and by 
supporting communities' efforts to build better systems of care. The 
NHSC and NURSE Corps Interest Capture Form, which will be used when 
exhibiting at national and regional conferences, as well as when 
presenting on campuses to health profession students, is an optional 
form that a health profession student, licensed clinician, faculty 
member, or clinical site administrator can fill out and submit to BCRS 
representatives at the recruitment event. The purpose of the form is to 
enable individuals and clinical sites to ask BCRS for periodic program 
updates and other general information regarding opportunities with the 
NHSC and/or the NURSE Corps via email. Completed forms will contain 
information such as the names of the individuals, their email 
address(es), their city and state, the organization where they are 
employed (or the school which they attend), the year they intend to 
graduate (if applicable), how they heard about the NHSC/NURSE Corps, 
and the programs in which they are interested. Assistance in completing 
the form will be given by the BCRS staff person (or BCRS 
representative) who is present at the event.
    Need and Proposed Use of the Information: The need and purpose of 
this information collection is to share resources and information 
regarding the NHSC and Nurse Corps programs with interested conference/
event participants.
    Likely Respondents: Conference/event participants interested in the 
NHSC or Nurse Corps programs.
    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 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)
----------------------------------------------------------------------------------------------------------------
NHSC and NURSE Corps Interest              2,400               1           2,400            .025              60
 Capture Form...................
                                 -------------------------------------------------------------------------------
    Total.......................           2,400               1           2,400            .025              60
----------------------------------------------------------------------------------------------------------------

    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.

    Dated: November 13, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-27798 Filed 11-19-13; 8:45 am]
BILLING CODE 4165-15-P