Proposed Collection, 60-day Comment Request: Certificate of Confidentiality Electronic Application System, 25090-25091 [2013-10041]
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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 https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
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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 https://
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:
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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
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NIH grantees and others in possession of hESC lines ...................................
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Number of
responses per
respondent
50
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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]
-----------------------------------------------------------------------
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
