Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 9485-9486 [2016-04056]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices
• Inspection of vehicle’s interior and
exterior (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Inspection, via metal detector or
other applicable means, of all persons
entering the building. We note that all
items brought into CMS, whether
personal or for the purpose of
presentation or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set up, safety, or
timely arrival of any personal
belongings or items used for
presentation or to support a
presentation.
Note: Individuals who are not registered in
advance will not be permitted to enter the
building and will be unable to attend the
meeting. The public may not enter the
building earlier than 45 minutes prior to the
convening of the meeting.
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building.
Authority: Sec. 222 of the Public Health
Service Act (42 U.S.C. 217a) and sec. 10(a)
of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a)
and 41 CFR 102–3).
Dated: February 18, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–04091 Filed 2–24–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Developing an Evidentiary Standards
Framework for Safety Biomarkers
Qualification; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), in cosponsorship with the Foundation for the
National Institutes of Health Biomarkers
Consortium (FNIH BC), is announcing a
public workshop entitled ‘‘Developing
an Evidentiary Standards Framework for
Safety Biomarkers Qualification
Workshop.’’ The purpose of the
workshop is to discuss the evidentiary
standards needed to support biomarker
qualification with a particular emphasis
on drug safety markers. The 2-day
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:07 Feb 24, 2016
Jkt 238001
workshop will focus on the standards
relevant to the qualification of a range
of safety biomarkers and examine case
studies in several different organ
systems.
DATES: The public workshop will be
held on April 14, 2016, from 9 a.m. to
5 p.m. and April 15, 2016, from 8 a.m.
to 5 p.m.
ADDRESSES: The public workshop will
be held at the Bethesda North Marriott
Hotel and Conference Center, 5701
Marinelli Rd., Bethesda, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Janelle Lewis, Foundation for the
National Institutes of Health, 9650
Rockville Pike, Bethesda, MD 20814,
301–594–2919, FAX: 301–480–2752,
email: jlewis@fnih.org.
SUPPLEMENTARY INFORMATION: The need
for evidentiary standards to qualify
biomarkers was identified in FDA’s
Critical Path Initiative as essential to
improving the efficiency and
effectiveness of drug development.
Evidentiary standards vary among
different types of biomarkers and
according to the context(s) of use (COU)
for which qualification is being
considered, and there are specific
challenges involved in qualifying drug
safety biomarkers. This workshop is
aimed at creating alignment among
scientific stakeholders including FDA,
the National Institutes of Health (NIH),
the biopharmaceutical industry,
academic researchers, and patient
groups regarding a proposed framework
for determining the levels of evidence
required to qualify biomarkers for use in
drug development, with an emphasis on
biomarkers used in determinations of
drug safety assessments. Development
of a general framework for biomarker
qualification will be discussed, along
with specific application to different
COUs related to drug safety, including
consideration of several specific case
studies involving qualification of
clinical markers of toxicity in different
organ systems.
Registration: There is no fee to attend
the workshop, but attendees must
register in advance. Space is limited,
and registration will be on a first-come,
first-served basis. Persons interested in
attending this workshop must register
online at www.fnih.org/
evidentiarystandardsworkshop by April
1, 2016. For those persons without
Internet access, please contact Janelle
Lewis at the Foundation for the NIH (see
FOR FURTHER INFORMATION CONTACT) to
register.
Attendees are responsible for their
own hotel accommodations. Attendees
making reservations at the Bethesda
North Marriott Hotel and Conference
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
9485
Center (see ADDRESSES) are eligible for a
reduced rate of $226 per night
(equivalent to the government per diem
rate), not including applicable taxes. To
receive the reduced rate, follow the Web
link that will be provided to you upon
completion of online registration.
If you need special accommodations
due to a disability, please contact
Janelle Lewis (see FOR FURTHER
INFORMATION CONTACT) at the Foundation
for the NIH at least 7 days in advance
of the workshop.
Dated: February 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–04027 Filed 2–24–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–4040–0010 60D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
AGENCY:
Electronic Government Office,
HHS.
ACTION:
Notice.
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Electronic
Government Office (EGOV), Department
of Health and Human Services, has
submitted an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB) for review and approval. The ICR
is for a 3-year extension for OMB
Control Number 4040–0010. The ICR
will expire on September 30, 2016. The
4040–0010 is composed of the following
forms: Project Abstract; Project
Performance Site Location(s); and Key
Contacts. The ICR also requests
categorizing these forms as common
forms, meaning HHS will only request
approval for its own use of the form
rather than aggregating the burden
estimate across all Federal Agencies as
was done for previous actions on this
OMB control number. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before April 25, 2016.
ADDRESSES: Submit your comments to
ed.calimag@hhs.gov or (202) 690–7569.
SUMMARY:
E:\FR\FM\25FEN1.SGM
25FEN1
9486
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the OMB
control number 4040–0010. Form is
available at https://www.grants.gov or
upon request.
Information Collection Request Title:
Project Abstract; Project Performance
Site Location(s); Key Contacts.
OMB No.: 4040–0010.
Abstract: The Project Abstract; Project
Performance Site Location(s); Key
Contacts forms are used by Federal
grant-making agencies for applicants to
apply for Federal financial assistance.
Need and Proposed Use of the
Information: The Project Abstract;
Project Performance Site Location(s);
Key Contacts forms are used by the
public to apply for Federal financial
assistance in the form of grants. These
HHS estimates that each of the
respective forms will take 1 hour to
complete. Once OMB approves the use
of the Project Abstract; Project
Performance Site Location(s); Key
Contacts forms as common forms,
federal agencies may request OMB
approval to use this common form
without having to publish notices and
request public comments for 60 and 30
days. Each agency must account for the
burden associated with their use of the
common form.
EGOV 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.
forms are submitted to the Federal
grant-making agencies for evaluation
and review.
Likely Respondents: Organizations
and institutions seeking grants.
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 ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total
burden hours
Project Abstract ...............................................................................................
Project Performance Site Location(s) ..............................................................
Key Contacts ...................................................................................................
85
143,567
3,565
1
1
1
1
1
1
85
143,567
3,565
Total ..........................................................................................................
147,217
........................
........................
147,217
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2016–04056 Filed 2–24–16; 8:45 am]
BILLING CODE 4150–57–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–4040–0001 60D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
AGENCY:
Electronic Government Office,
HHS.
ACTION:
Notice.
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Electronic
Government Office (EGOV), Department
of Health and Human Services, has
submitted an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB) for review and approval. The ICR
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:07 Feb 24, 2016
Jkt 238001
is for a 3-year extension for OMB
Control Number 4040–0001. The ICR
will expire on June 30, 2016. The ICR
also requests categorizing 4040–0001 as
a common form, meaning HHS will only
request approval for its own use of the
form rather than aggregating the burden
estimate across all Federal Agencies as
was done for previous actions on this
OMB control number. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before April 25, 2016.
ADDRESSES: Submit your comments to
ed.calimag@hhs.gov or (202) 690–7569.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the OMB
control number 4040–0001. Form is
available https://www.grants.gov or upon
request.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Information Collection Request Title:
SF–424 Application for Federal
Assistance—Research and Related.
OMB No.: 4040–0001.
Abstract: The SF–424 Application for
Federal Assistance—Research and
Related is a set of common forms used
by Federal research grant-making
agencies for organizations to apply for
Federal financial assistance.
Need and Proposed Use of the
Information: The SF–424 Application
for Federal Assistance—Research and
Related forms are used by organizations
to apply for Federal financial assistance
in the form of research-based grants.
These forms are submitted to the
Federal grant-making agencies for
evaluation and review.
Likely Respondents: Organizations
and institutions seeking research-based
grants. 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
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Pages 9485-9486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04056]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS-4040-0010 60D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Electronic Government Office, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Electronic Government Office (EGOV),
Department of Health and Human Services, has submitted an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB) for review and approval. The ICR is for a 3-year
extension for OMB Control Number 4040-0010. The ICR will expire on
September 30, 2016. The 4040-0010 is composed of the following forms:
Project Abstract; Project Performance Site Location(s); and Key
Contacts. The ICR also requests categorizing these forms as common
forms, meaning HHS will only request approval for its own use of the
form rather than aggregating the burden estimate across all Federal
Agencies as was done for previous actions on this OMB control number.
Comments submitted during the first public review of this ICR will be
provided to OMB. OMB will accept further comments from the public on
this ICR during the review and approval period.
DATES: Comments on the ICR must be received on or before April 25,
2016.
ADDRESSES: Submit your comments to ed.calimag@hhs.gov or (202) 690-
7569.
[[Page 9486]]
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the OMB control number 4040-0010. Form is
available at https://www.grants.gov or upon request.
Information Collection Request Title: Project Abstract; Project
Performance Site Location(s); Key Contacts.
OMB No.: 4040-0010.
Abstract: The Project Abstract; Project Performance Site
Location(s); Key Contacts forms are used by Federal grant-making
agencies for applicants to apply for Federal financial assistance.
Need and Proposed Use of the Information: The Project Abstract;
Project Performance Site Location(s); Key Contacts forms are used by
the public to apply for Federal financial assistance in the form of
grants. These forms are submitted to the Federal grant-making agencies
for evaluation and review.
Likely Respondents: Organizations and institutions seeking grants.
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 ICR are summarized in the table below.
HHS estimates that each of the respective forms will take 1 hour to
complete. Once OMB approves the use of the Project Abstract; Project
Performance Site Location(s); Key Contacts forms as common forms,
federal agencies may request OMB approval to use this common form
without having to publish notices and request public comments for 60
and 30 days. Each agency must account for the burden associated with
their use of the common form.
EGOV 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.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Project Abstract................................ 85 1 1 85
Project Performance Site Location(s)............ 143,567 1 1 143,567
Key Contacts.................................... 3,565 1 1 3,565
---------------------------------------------------------------
Total....................................... 147,217 .............. .............. 147,217
----------------------------------------------------------------------------------------------------------------
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2016-04056 Filed 2-24-16; 8:45 am]
BILLING CODE 4150-57-P
