Proposed Collection, 60-day Comment Request: Certificate of Confidentiality Electronic Application System, 25090-25091 [2013-10041]

Download as PDF emcdonald on DSK67QTVN1PROD with NOTICES 25090 Federal Register / Vol. 78, No. 82 / Monday, April 29, 2013 / Notices 12,037; Total Annual Responses: 300,148; Total Annual Hours: 75,037. (For policy questions regarding this collection contact Fred Rooke at 404– 562–7205. For all other issues call 410– 786–1326.) 4. Type of Information Collection Request: New Collection; Title of Information Collection: Evaluation of the Multi-Payer Advanced Primary Care Practice (MAPCP) Demonstration Focus Group Protocols; Use: On September 16, 2009, the Department of Health and Human Services announced the establishment of the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration, under which Medicare joined Medicaid and private insurers as a payer participant in statesponsored patient-centered medical home (PCMH) initiatives. CMS selected eight states to participate in this demonstration: Maine, Vermont, Rhode Island, New York, Pennsylvania, North Carolina, Michigan, and Minnesota. CMS is proposing to conduct in-person focus groups with Medicare and Medicaid beneficiaries and their caregivers to more thoroughly understand patients’ experiences with their PCMHs and how well their PCMHs are serving their needs. The focus groups will provide CMS with answers to fundamental ‘‘what, how, and why’’ questions about beneficiaries’ experiences with care and access to and coordination of care. The information obtained via in-person, focus groups will be utilized by CMS for the evaluation of the MAPCP Demonstration. The focus group data will be collected to supplement other qualitative and quantitative analyses from primary and secondary data sources by providing data on context, structure, and process, as well as select aspects of the key outcomes. The data gathered from the interviews will allow for more complete interpretation of the quantitative claims and other data analysis by taking into account the unique perspectives of beneficiaries. Form Number: CMS–10479 (OCN: 0938–NEW); Frequency: Annually; Affected Public: Individuals and households; Number of Respondents: 768; Total Annual Responses: 384; Total Annual Hours: 1,152. (For policy questions regarding this collection contact Suzanne Goodwin at 410–786– 0226. For all other issues call 410–786– 1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your VerDate Mar<15>2010 14:16 Apr 26, 2013 Jkt 229001 address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by June 28, 2013: 1. Electronically. You may submit your comments electronically to http:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number llll, Room C4–26– 05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: April 23, 2013. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2013–09948 Filed 4–26–13; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection, 60-day Comment Request: Certificate of Confidentiality Electronic Application System In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, to provide the opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER) of the National Institutes of Health (NIH) is developing an electronic application form for the submission of requests to NIH for Certificates of Confidentiality (CoCs). Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Ann M. Hardy, NIH Extramural Human Research Protections Officer and Coordinator, Certificates of Confidentiality, Office of Extramural Programs, OER, NIH, 3701 Rockledge Drive, Room 3002, Bethesda, MD 20892; or call the non-toll-free number (301) 435–2690; or email your request, including your address, to hardyan@od.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Certificate of Confidentiality Electronic Application System 0925–New, Office of Extramural Research (OER), National Institutes of Health (NIH). Need and Use of Information Collection: This application system will provide one electronic form to be used by all research organizations that wish to request a Certificate of Confidentiality (CoC) from NIH. As described in the authorizing legislation (Section 301(d) of the Public Health Service Act, 42 U.S.C. 241(d)), CoCs are issued by the agencies of the Department of Health and Human Services (HHS), including NIH, to authorize researchers conducting sensitive research to protect the privacy of human research subjects by enabling them to refuse to release names and identifying characteristics of subjects to anyone not connected with the research. At the NIH, the issuance of CoCs has been delegated to the individual NIH Institutes and Centers (ICs). The NIH ICs collectively issue approximately 1,000 new CoCs each year for eligible research projects. However, the process for submitting a CoC request is not consistent across the ICs, which creates confusion for applicants. To make the application process consistent across the entire agency, the OER is proposing to use an electronic application system that will be accessed by research organizations that wish to request a CoC from any NIH E:\FR\FM\29APN1.SGM 29APN1 25091 Federal Register / Vol. 78, No. 82 / Monday, April 29, 2013 / Notices IC. Having one system for all CoC applications to NIH will be efficient for both applicants and NIH staff who process these requests. As is currently done, the NIH will use the information in the application to determine eligibility for a CoC and to issue the CoC to the requesting organization. Office of Management and Budget approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours is 1,500. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Number of respondents CoC Applicants- ............................................................................................... Private .............................................................................................................. CoC Applicants- ............................................................................................... State/local ........................................................................................................ CoC Applicants- ............................................................................................... Small business ................................................................................................. CoC Applicants- ............................................................................................... Federal ............................................................................................................. Dated: April 22, 2013. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2013–10041 Filed 4–26–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH-Funded Research Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection instrument listed below. This proposed information collection was previously published in the Federal Register on February 28, 2013, pages 13688–13689, and allowed 60 days for public SUMMARY: Frequency of response Average time per response (in hours) Total annual burden hours 400 1 1.5 600 450 1 1.5 675 50 1 1.5 75 100 1 1.5 150 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. Direct Comments to OMB: 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. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Ellen Gadbois, Office of Science Policy, Office of the Director, NIH, Building 1, Room 218, MSC 0166, 1 Center Drive, Bethesda, MD 20892; or call the non-toll-free number 301–496– 1454; or email your request, including your address, to gadboisel@od.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH-Funded Research, 0925–0601, Expiration Date 04/30/2013—EXTENSION, Office of Extramural Research, National Institutes of Health (NIH). Need and Use of Information Collection: The form is used by applicants to request that human embryonic stem cell lines be approved for use in NIH-funded research. Applicants may submit applications at any time. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours is 2,550. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent emcdonald on DSK67QTVN1PROD with NOTICES NIH grantees and others in possession of hESC lines ................................... VerDate Mar<15>2010 14:16 Apr 26, 2013 Jkt 229001 PO 00000 Frm 00034 Fmt 4703 Sfmt 9990 Number of responses per respondent 50 E:\FR\FM\29APN1.SGM 3 29APN1 Average time per response (in hours) 17 Total annual burden hour 2,550

Agencies

[Federal Register Volume 78, Number 82 (Monday, April 29, 2013)]
[Notices]
[Pages 25090-25091]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10041]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection, 60-day Comment Request: Certificate of 
Confidentiality Electronic Application System

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, to provide the opportunity for 
public comment on proposed data collection projects, the Office of 
Extramural Research (OER) of the National Institutes of Health (NIH) is 
developing an electronic application form for the submission of 
requests to NIH for Certificates of Confidentiality (CoCs).
    Written comments and/or suggestions from the public and affected 
agencies are invited on one or more of the following points: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of the function of the agency, including whether the 
information will have practical utility; (2) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    To Submit Comments and For Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Dr. Ann 
M. Hardy, NIH Extramural Human Research Protections Officer and 
Coordinator, Certificates of Confidentiality, Office of Extramural 
Programs, OER, NIH, 3701 Rockledge Drive, Room 3002, Bethesda, MD 
20892; or call the non-toll-free number (301) 435-2690; or email your 
request, including your address, to hardyan@od.nih.gov. Formal requests 
for additional plans and instruments must be requested in writing.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: Certificate of Confidentiality Electronic 
Application System 0925-New, Office of Extramural Research (OER), 
National Institutes of Health (NIH).
    Need and Use of Information Collection: This application system 
will provide one electronic form to be used by all research 
organizations that wish to request a Certificate of Confidentiality 
(CoC) from NIH. As described in the authorizing legislation (Section 
301(d) of the Public Health Service Act, 42 U.S.C. 241(d)), CoCs are 
issued by the agencies of the Department of Health and Human Services 
(HHS), including NIH, to authorize researchers conducting sensitive 
research to protect the privacy of human research subjects by enabling 
them to refuse to release names and identifying characteristics of 
subjects to anyone not connected with the research. At the NIH, the 
issuance of CoCs has been delegated to the individual NIH Institutes 
and Centers (ICs). The NIH ICs collectively issue approximately 1,000 
new CoCs each year for eligible research projects. However, the process 
for submitting a CoC request is not consistent across the ICs, which 
creates confusion for applicants. To make the application process 
consistent across the entire agency, the OER is proposing to use an 
electronic application system that will be accessed by research 
organizations that wish to request a CoC from any NIH

[[Page 25091]]

IC. Having one system for all CoC applications to NIH will be efficient 
for both applicants and NIH staff who process these requests. As is 
currently done, the NIH will use the information in the application to 
determine eligibility for a CoC and to issue the CoC to the requesting 
organization.
    Office of Management and Budget approval is requested for 3 years. 
There are no costs to respondents other than their time. The total 
estimated annualized burden hours is 1,500.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
               Type of respondents                   Number of     Frequency of    per response    Total annual
                                                    respondents      response       (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
CoC Applicants-.................................             400               1             1.5             600
Private.........................................
CoC Applicants-.................................             450               1             1.5             675
State/local.....................................
CoC Applicants-.................................              50               1             1.5              75
Small business..................................
CoC Applicants-.................................             100               1             1.5             150
Federal.........................................
----------------------------------------------------------------------------------------------------------------


    Dated: April 22, 2013.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2013-10041 Filed 4-26-13; 8:45 am]
BILLING CODE 4140-01-P