Request for Comments Under the Paperwork Reduction Act, Section 3506, 61008-61009 [2012-24623]
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61008
Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices
Documentation (EID) (OMB No. 0915–
0324) Revision.
HRSA is requesting extension of the
approval for the Environmental
Information and Documentation (EID)
checklist which consists of information
that the agency is required to obtain to
comply with the National
Environmental Policy Act of 1969
(NEPA). NEPA establishes the federal
government’s national policy for
protection of the environment. HRSA
has developed the EID for applicants of
funding that would potentially impact
Number of
respondents
Instrument
Responses
per
respondent
the environment and to ensure that their
decision-making processes are
consistent with NEPA. Applicants must
provide information and assurance of
compliance with NEPA on the EID
checklist. The estimated annual burden
is as follows:
Total
responses
Hours per
response
Total burden
hours
NEPA EID Checklist ............................................................
2,734
1
2,734
1
2,734
Total ..............................................................................
2,734
1
2,734
1
2,734
Email comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: October 2, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–24626 Filed 10–4–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Comments Under the
Paperwork Reduction Act, Section
3506
National Institutes of Health
(NIH), HHS.
ACTION: Request for comments.
AGENCY:
The National Institutes of
Health (NIH), as part of its continuing
effort to reduce paperwork and
respondent burden, invites the general
public and other Federal agencies to
take this opportunity to comment on
proposed and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995,
Section 3506.
Proposed Collection: Title: National
Institutes of Health Information
Collection Forms to Support Genomic
Data Sharing for Research Purposes;
Type of Information Collection Request:
New; Need and Use of Information
Collection: The NIH mission is to seek
fundamental knowledge about the
nature and behavior of living systems
and the application of that knowledge to
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
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enhance health, lengthen life, and
reduce the burdens of illness and
disability. The sharing of research data
supports this mission and is essential to
facilitate the translation of research
results into knowledge, products,
practices, and procedures that improve
human health.
By enabling secondary research
questions to be addressed, data sharing
maximizes the public benefit achieved
through research investments. NIH’s
Policy for Sharing of Data Obtained in
NIH Supported or Conducted GenomeWide Association Studies (GWAS) was
established to enable the full value of
GWAS data to be realized. GWAS data
are maintained in a central data
repository, the database of Genotypes
and Phenotypes (dbGaP), which is
administered by the National Center for
Biotechnology Information (NCBI), part
of the National Library of Medicine at
NIH.
As stipulated in the NIH GWAS
policy, all principal investigators (PIs)
who receive NIH funding to conduct
genomic research are expected to
register studies with genomic data in
dbGaP. The nature of the genomic,
phenotypic, and other associated data
generated through large-scale human
genomic studies requires responsible
stewardship throughout research and
data sharing activities. Since the data
being collected and shared are from
human research participants, the
protection of participant interests is
paramount. PIs submitting data to
dbGaP must describe any limitations on
sharing the data, as defined in the
informed consent provided by the
participants from whom the data were
originally collected. PIs must also
provide basic study information such as
the type of data that will be submitted
to dbGaP and a description of the study.
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Researchers interested in using dbGaP
data for secondary research must submit
a request through dbGaP and be granted
permission from the relevant NIH Data
Access Committees to access the data.
As part of the request process,
researchers must provide information
such as a description of the proposed
research use of the dbGaP datasets, a
data security plan, and a Data Use
Certification, in which the researcher
agrees to the terms and conditions for
use of the data. NIH has developed
online forms, which will be available
through dbGaP, in an effort to reduce
the burden for researchers to complete
the study registration, data submission,
and data access processes.
Frequency of Response: As necessary.
Description of Respondents: PIs and
senior officials from their institutions.
Estimate of Burden: The burden
associated with this information
collection is calculated in two parts: (1)
The burden associated with registering
genomic studies and submitting data to
dbGaP and (2) the burden associated
with applying for genomic data in
dbGaP. The annual reporting burden for
study registration and data submission
is as follows: Estimated Number of
Respondents: 100; Estimated Number of
Responses per Respondent: 1; and
Estimated Total Annual Burden Hours
Requested: 63. The annual cost to
respondents is estimated at $2,506. The
annual reporting burden for applying for
genomic data in dbGaP is as follows:
Estimated Number of Respondents:
1,266; Estimated Number of Responses
per Respondent: 2; and Estimated Total
Annual Burden Hours Requested: 1,583.
The annual cost to respondents is
estimated at $63,452. There are no
capital, operating, or maintenance costs
to the respondents.
E:\FR\FM\05OCN1.SGM
05OCN1
61009
Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices
Estimated
number of
respondents
Type of respondent
Estimated
number of responses per
respondent
Average
burden per
response
(in hours)
Estimated total
annual burden
hours
Study Registration and Data Submission
PI ......................................................................................................................
Senior Official ..................................................................................................
50
50
1
1
45/60
30/60
38
25
Total ..........................................................................................................
100
........................
........................
63
PI ......................................................................................................................
Senior Official ..................................................................................................
633
633
2
2
45/60
30/60
950
633
Total ..........................................................................................................
1,266
........................
........................
1,583
Data Access Request
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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
request additional information on the
proposed information collection,
contact: Sarah Carr, Acting Director,
Office of Clinical Research and
Bioethics Policy, Office of Science
Policy, NIH, 6705 Rockledge Drive,
Suite 750, Bethesda, MD 20892;
telephone 301–496–9838; fax 301–496–
9839; or email GWAS@mail.nih.gov,
Attention: Ms. Carr.
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. Comments should be
directed to Ms. Carr through the contact
information above.
pmangrum on DSK3VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Dated: September 28, 2012.
Sarah Carr,
Acting Director, Office of Clinical Research
and Bioethics Policy, Office of Science Policy,
NIH.
[FR Doc. 2012–24623 Filed 10–4–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Dated: October 1, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–24579 Filed 10–4–12; 8:45 am]
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the public
in accordance with the provisions set
forth in sections 552b(c)(4) and
552b(c)(6), Title 5 U.S.C., as amended.
The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Resource Related
Research Projects for AIDS, Allergy,
Immunology & Transplantation.
Date: October 25, 2012.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817.
Contact Person: Dharmendar Rathore,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institutes of Health/
NIAID, 6700B Rockledge Drive, MSC 7616,
Rm. 3134, Bethesda, MD 20892–7616, 301–
435–2766, rathored@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Immunologic Mechanisms.
Date: October 17, 2012.
Time: 10 a.m. to 7 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6705
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Stephen M. Nigida, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4212,
MSC 7812, Bethesda, MD 20892, 301–435–
1222, nigidas@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
E:\FR\FM\05OCN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61008-61009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24623]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Comments Under the Paperwork Reduction Act, Section
3506
AGENCY: National Institutes of Health (NIH), HHS.
ACTION: Request for comments.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on proposed and/or continuing information collections, as
required by the Paperwork Reduction Act of 1995, Section 3506.
Proposed Collection: Title: National Institutes of Health
Information Collection Forms to Support Genomic Data Sharing for
Research Purposes; Type of Information Collection Request: New; Need
and Use of Information Collection: The NIH mission is to seek
fundamental knowledge about the nature and behavior of living systems
and the application of that knowledge to enhance health, lengthen life,
and reduce the burdens of illness and disability. The sharing of
research data supports this mission and is essential to facilitate the
translation of research results into knowledge, products, practices,
and procedures that improve human health.
By enabling secondary research questions to be addressed, data
sharing maximizes the public benefit achieved through research
investments. NIH's Policy for Sharing of Data Obtained in NIH Supported
or Conducted Genome-Wide Association Studies (GWAS) was established to
enable the full value of GWAS data to be realized. GWAS data are
maintained in a central data repository, the database of Genotypes and
Phenotypes (dbGaP), which is administered by the National Center for
Biotechnology Information (NCBI), part of the National Library of
Medicine at NIH.
As stipulated in the NIH GWAS policy, all principal investigators
(PIs) who receive NIH funding to conduct genomic research are expected
to register studies with genomic data in dbGaP. The nature of the
genomic, phenotypic, and other associated data generated through large-
scale human genomic studies requires responsible stewardship throughout
research and data sharing activities. Since the data being collected
and shared are from human research participants, the protection of
participant interests is paramount. PIs submitting data to dbGaP must
describe any limitations on sharing the data, as defined in the
informed consent provided by the participants from whom the data were
originally collected. PIs must also provide basic study information
such as the type of data that will be submitted to dbGaP and a
description of the study.
Researchers interested in using dbGaP data for secondary research
must submit a request through dbGaP and be granted permission from the
relevant NIH Data Access Committees to access the data. As part of the
request process, researchers must provide information such as a
description of the proposed research use of the dbGaP datasets, a data
security plan, and a Data Use Certification, in which the researcher
agrees to the terms and conditions for use of the data. NIH has
developed online forms, which will be available through dbGaP, in an
effort to reduce the burden for researchers to complete the study
registration, data submission, and data access processes.
Frequency of Response: As necessary.
Description of Respondents: PIs and senior officials from their
institutions.
Estimate of Burden: The burden associated with this information
collection is calculated in two parts: (1) The burden associated with
registering genomic studies and submitting data to dbGaP and (2) the
burden associated with applying for genomic data in dbGaP. The annual
reporting burden for study registration and data submission is as
follows: Estimated Number of Respondents: 100; Estimated Number of
Responses per Respondent: 1; and Estimated Total Annual Burden Hours
Requested: 63. The annual cost to respondents is estimated at $2,506.
The annual reporting burden for applying for genomic data in dbGaP is
as follows: Estimated Number of Respondents: 1,266; Estimated Number of
Responses per Respondent: 2; and Estimated Total Annual Burden Hours
Requested: 1,583. The annual cost to respondents is estimated at
$63,452. There are no capital, operating, or maintenance costs to the
respondents.
[[Page 61009]]
----------------------------------------------------------------------------------------------------------------
Estimated Average
Estimated number of burden per Estimated
Type of respondent number of responses per response (in total annual
respondents respondent hours) burden hours
----------------------------------------------------------------------------------------------------------------
Study Registration and Data Submission
----------------------------------------------------------------------------------------------------------------
PI.............................................. 50 1 45/60 38
Senior Official................................. 50 1 30/60 25
---------------------------------------------------------------
Total....................................... 100 .............. .............. 63
----------------------------------------------------------------------------------------------------------------
Data Access Request
----------------------------------------------------------------------------------------------------------------
PI.............................................. 633 2 45/60 950
Senior Official................................. 633 2 30/60 633
---------------------------------------------------------------
Total....................................... 1,266 .............. .............. 1,583
----------------------------------------------------------------------------------------------------------------
Request For Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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.
FOR FURTHER INFORMATION CONTACT: To request additional information on
the proposed information collection, contact: Sarah Carr, Acting
Director, Office of Clinical Research and Bioethics Policy, Office of
Science Policy, NIH, 6705 Rockledge Drive, Suite 750, Bethesda, MD
20892; telephone 301-496-9838; fax 301-496-9839; or email
GWAS@mail.nih.gov, Attention: Ms. Carr.
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. Comments should be directed to Ms.
Carr through the contact information above.
Dated: September 28, 2012.
Sarah Carr,
Acting Director, Office of Clinical Research and Bioethics Policy,
Office of Science Policy, NIH.
[FR Doc. 2012-24623 Filed 10-4-12; 8:45 am]
BILLING CODE 4140-01-P
