Submission for OMB Review; Comment Request: Palliative Care: Conversations Matter Evaluation, 53152-53153 [2013-21005]

Download as PDF 53152 Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Notices III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or from CBER at https://www.fda.gov/Biologics BloodVaccines/ GuidanceComplianceRegulatory Information/default.htm. To receive ‘‘The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1779 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration National Institutes of Health [Docket No. FDA–2013–N–0007] Submission for OMB Review; Comment Request: Palliative Care: Conversations Matter Evaluation Prescription Drug User Fee Rates for Fiscal Year 2014; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Prescription Drug User Fee Rates for Fiscal Year 2014’’ that appeared in the Federal Register of August 2, 2013 (78 FR 46980). The document announced the Fiscal Year 2014 fee rates for the Prescription Drug User Fee Act. The document was published with four errors. This document corrects those errors. SUMMARY: FOR FURTHER INFORMATION CONTACT: The draft guidance refers to currently approved collections of information found in FDA regulations. These collections of information 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 part 807, subpart E, have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; and the collections of information in 21 CFR part 814 have been approved under OMB control number 0910–0231. David Miller, Office of Financial Management (HFA–100), Food and Drug Administration, 1350 Piccard Dr., PI50, Rm. 210J, Rockville, MD 20850, 301– 796–7103. Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. In the Federal Register of Friday, August 2, 2013, in FR Doc. 2013–18624, on pages 46981 and 46982 the following corrections are made: 1. On page 46981, in the second column, in the second sentence of the second paragraph under I. Background, ‘‘$718,699,000’’ is corrected to read ‘‘$718,669,000’’. 2. On page 46981, in the third column, in the first sentence of the first paragraph under II. Fee Revenue Amount for 2014, ‘‘$718,699,000’’ is corrected to read ‘‘$718,669,000’’. 3. On page 46981, in the third column, in the first sentence of the first paragraph under A. FY 2014 Statutory Fee Revenue Adjustments for Inflation, ‘‘$718,699,000’’ is corrected to read ‘‘$718,669,000’’. 4. On page 46982, in the first column, in the first sentence of the first paragraph under B. FY 2014 Statutory Fee Revenue Adjustments for Workload, ‘‘$718,699,000’’ is corrected to read ‘‘$718,669,000’’. Dated: August 22, 2013. Leslie Kux, Assistant Commissioner for Policy. Dated: August 22, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–20916 Filed 8–27–13; 8:45 am] [FR Doc. 2013–20958 Filed 8–27–13; 8:45 am] BILLING CODE 4160–01–P BILLING CODE 4160–01–P V. Comments wreier-aviles on DSK5TPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Mar<15>2010 15:21 Aug 27, 2013 Jkt 229001 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Nursing Research (NINR), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June, 14, 2013, page 35942 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_ submission@omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Adrienne Burroughs, Health Communications Specialist, Office of Communications and Public Liaison, NINR, NIH, Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892, or call nontoll-free number (301) 496–0256, or Email your request, including your address to: adrienne.burroughs@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Palliative Care: Conversations Matter Evaluation, -0925New—National Institute of Nursing Research (NINR), National Institutes of Health (NIH). Need and Use of Information Collection: NINR developed Palliative Care: Conversations Matter, a pediatric palliative care campaign to address the communications challenges faced by health care providers who recommend SUMMARY: E:\FR\FM\28AUN1.SGM 28AUN1 53153 Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Notices and provide palliative care to pediatric populations. NINR is launching this effort to increase the use of palliative care for children living with serious illness or life-limiting conditions. The Palliative Care: Conversations Matter evaluation will assess the information and materials being disseminated as part of the official campaign. Survey findings will help (1) Determine if the campaign is effective, relevant, and useful to health care providers who recommend and provide palliative care to pediatric populations; (2) to better understand the information needs of health care providers to inform future campaign efforts; and (3) examine how effective the campaign materials are in starting and continuing a pediatric palliative care conversation and addressing the communications needs of health care providers around this topic. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 200. Estimated Annualized Burden Hours TABLE A–12–1—ESTIMATES OF ANNUAL BURDEN HOURS Number of respondents Type of respondents Average time per response (in hours ) Frequency of response Total burden hours Physicians ........................................................................................ Nurses .............................................................................................. 150 150 2 2 20/60 20/60 100 100 Total .......................................................................................... 300 ............................ ............................ 200 * The average time for completing one of the surveys is 20 minutes; this includes reading the consent form on page 1 of the survey. Dated: August 19, 2013. Amanda Greene, NINR PRA Liaison, Science Evaluation Officer, NINR, NIH. [FR Doc. 2013–21005 Filed 8–27–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Use of Exenatide for the Treatment of Neurodegenerative Diseases AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Peptron, Inc., a company having a place of business in Daejeon, South Korea, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/309,076, filed July 31, 2001, entitled ‘‘Long-Acting Insulinotropic Peptides and Uses Thereof’’ (HHS Ref. No. E– 049–2001/0–US–01); U.S. Patent No. 7,576,050, issued August 18, 2009, entitled ‘‘GLP–1 Exendin–4 Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–US–03); U.S. Patent No. 8,278,272, issued October 2, 2012, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–US–14); U.S. Patent Application No. 13/594,313, filed August 24, 2012, entitled ‘‘GLP–1, wreier-aviles on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:21 Aug 27, 2013 Jkt 229001 Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0– US–21); PCT Patent Application No. PCT/US2002/024141, filed July 30, 2002, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–PCT–02); Australian Patent No. 2002317599, issued July 17, 2008, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0– AU–04); Australian Patent No. 2008202893, issued April 26, 2012, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–AU–10); Australian Patent Application No. 2012202081, filed April 11, 2012, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0– AU–20); Canadian Patent Application No. 2455963, filed January 29, 2004, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–CA–05); European Patent No. 1411968, issued September 17, 2008, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–EP–06) and validated in Germany (HHS Ref. No. E–049–2001/0–DE–11), France (HHS Ref. No. E–049–2001/0–FR–12), and Great Britain (HHS Ref. No. E–049– 2001/0–GB–13); European Patent No. 2022505, issued December 14, 2011, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–EP–09) and validated in Germany (HHS Ref. No. E– 049–2001/0–DE–17), France (HHS Ref. No. E–049–2001/0–FR–18), and Great Britain (HHS Ref. No. E–049–2001/0– GB–19); European Patent Application No. 10177860.3, filed September 21, 2010, entitled ‘‘GLP–1, Exendin–4, PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–EP–16); Indian Patent Application No. 0488/ DELNP/2004, filed February 27, 2004, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–IN–07); Japanese Patent Application No. 2003–517083, filed February 2, 2004, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0– JP–08); Japanese Patent Application No. 2009–262568, filed November 18, 2009, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0–JP–15; and Japanese Patent Application No. 2013–007743, filed January 18, 2013, entitled ‘‘GLP–1, Exendin–4, Peptide Analogs and Uses Thereof’’ (HHS Ref. No. E–049–2001/0– JP–22). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Exclusive Patent License may be worldwide, and the field of use may be limited to ‘‘Methods of using exenatide for the treatment of neurodegenerative disease in humans.’’ DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before September 27, 2013 will be considered. ADDRESSES: Requests for copies of the patent application(s), inquiries, comments, and other materials relating to the contemplated Exclusive Patent License should be directed to: Tara L. Kirby, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4426; Facsimile: E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Notices]
[Pages 53152-53153]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21005]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; Comment Request: Palliative Care:
Conversations Matter Evaluation

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Nursing Research
(NINR), the National Institutes of Health (NIH) has submitted to the
Office of Management and Budget (OMB) a request for review and approval
of the information collection listed below. This proposed information
collection was previously published in the Federal Register on June,
14, 2013, page 35942 and allowed 60-days for public comment. No public
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Written comments and/or suggestions regarding the item(s) contained
in this notice, especially regarding the estimated public burden and
associated response time, should be directed to the: Office of
Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk
Officer. To obtain a copy of the data collection plans and instruments,
submit comments in writing, or request more information on the proposed
project, contact: Ms. Adrienne Burroughs, Health Communications
Specialist, Office of Communications and Public Liaison, NINR, NIH,
Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892, or call
non-toll-free number (301) 496-0256, or Email your request, including
your address to: adrienne.burroughs@nih.gov. Formal requests for
additional plans and instruments must be requested in writing.
Proposed Collection: Palliative Care: Conversations Matter
Evaluation, -0925-New--National Institute of Nursing Research (NINR),
National Institutes of Health (NIH).
Need and Use of Information Collection: NINR developed Palliative
Care: Conversations Matter, a pediatric palliative care campaign to
address the communications challenges faced by health care providers
who recommend

[[Page 53153]]

and provide palliative care to pediatric populations. NINR is launching
this effort to increase the use of palliative care for children living
with serious illness or life-limiting conditions. The Palliative Care:
Conversations Matter evaluation will assess the information and
materials being disseminated as part of the official campaign. Survey
findings will help (1) Determine if the campaign is effective,
relevant, and useful to health care providers who recommend and provide
palliative care to pediatric populations; (2) to better understand the
information needs of health care providers to inform future campaign
efforts; and (3) examine how effective the campaign materials are in
starting and continuing a pediatric palliative care conversation and
addressing the communications needs of health care providers around
this topic.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 200.

Estimated Annualized Burden Hours

Table A-12-1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Number of Frequency of per response (in Total burden
respondents response hours ) hours
----------------------------------------------------------------------------------------------------------------
Physicians.............................. 150 2 20/60 100
Nurses.................................. 150 2 20/60 100
-----------------------------------------------------------------------
Total............................... 300 ................ ................ 200
----------------------------------------------------------------------------------------------------------------
* The average time for completing one of the surveys is 20 minutes; this includes reading the consent form on
page 1 of the survey.

Dated: August 19, 2013.
Amanda Greene,
NINR PRA Liaison, Science Evaluation Officer, NINR, NIH.
[FR Doc. 2013-21005 Filed 8-27-13; 8:45 am]
BILLING CODE 4140-01-P

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