81 FR 9485 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 81, Issue 37 (February 25, 2016)

Page Range		9485-9486
FR Document		2016-04056

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.

Federal Register, Volume 81 Issue 37 (Thursday, February 25, 2016)

[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Pages 9485-9486]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-04056]

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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 http://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

Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices 9485

• Inspection of vehicle’s interior and workshop will focus on the standards Center (see ADDRESSES) are eligible for a
exterior (this includes engine and trunk relevant to the qualification of a range reduced rate of $226 per night
inspection) at the entrance to the of safety biomarkers and examine case (equivalent to the government per diem
grounds. Parking permits and studies in several different organ rate), not including applicable taxes. To
instructions will be issued after the systems. receive the reduced rate, follow the Web
vehicle inspection. DATES: The public workshop will be link that will be provided to you upon
• Inspection, via metal detector or held on April 14, 2016, from 9 a.m. to completion of online registration.
other applicable means, of all persons 5 p.m. and April 15, 2016, from 8 a.m. If you need special accommodations
entering the building. We note that all to 5 p.m. due to a disability, please contact
items brought into CMS, whether ADDRESSES: The public workshop will Janelle Lewis (see FOR FURTHER
personal or for the purpose of be held at the Bethesda North Marriott INFORMATION CONTACT) at the Foundation
presentation or to support a Hotel and Conference Center, 5701 for the NIH at least 7 days in advance
presentation, are subject to inspection. Marinelli Rd., Bethesda, MD 20852. of the workshop.
We cannot assume responsibility for Dated: February 19, 2016.
FOR FURTHER INFORMATION CONTACT:
coordinating the receipt, transfer,
Janelle Lewis, Foundation for the Leslie Kux,
transport, storage, set up, safety, or National Institutes of Health, 9650 Associate Commissioner for Policy.
timely arrival of any personal Rockville Pike, Bethesda, MD 20814, [FR Doc. 2016–04027 Filed 2–24–16; 8:45 am]
belongings or items used for 301–594–2919, FAX: 301–480–2752,
presentation or to support a BILLING CODE 4164–01–P
email: jlewis@fnih.org.
presentation.
SUPPLEMENTARY INFORMATION: The need
Note: Individuals who are not registered in for evidentiary standards to qualify DEPARTMENT OF HEALTH AND
advance will not be permitted to enter the biomarkers was identified in FDA’s HUMAN SERVICES
building and will be unable to attend the
Critical Path Initiative as essential to
meeting. The public may not enter the Office of the Secretary
building earlier than 45 minutes prior to the
improving the efficiency and
convening of the meeting. effectiveness of drug development.
Evidentiary standards vary among [Document Identifier: OS–4040–0010 60D]
All visitors must be escorted in areas different types of biomarkers and
other than the lower and first floor according to the context(s) of use (COU) Agency Information Collection
levels in the Central Building. for which qualification is being Activities; Submission to OMB for
Authority: Sec. 222 of the Public Health considered, and there are specific Review and Approval; Public Comment
Service Act (42 U.S.C. 217a) and sec. 10(a) challenges involved in qualifying drug Request
of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) safety biomarkers. This workshop is
and 41 CFR 102–3). AGENCY: Electronic Government Office,
aimed at creating alignment among
HHS.
Dated: February 18, 2016. scientific stakeholders including FDA,
the National Institutes of Health (NIH), ACTION: Notice.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare the biopharmaceutical industry, SUMMARY: In compliance with section
& Medicaid Services. academic researchers, and patient 3507(a)(1)(D) of the Paperwork
[FR Doc. 2016–04091 Filed 2–24–16; 8:45 am] groups regarding a proposed framework Reduction Act of 1995, the Electronic
BILLING CODE 4120–01–P
for determining the levels of evidence Government Office (EGOV), Department
required to qualify biomarkers for use in of Health and Human Services, has
drug development, with an emphasis on submitted an Information Collection
DEPARTMENT OF HEALTH AND biomarkers used in determinations of Request (ICR), described below, to the
HUMAN SERVICES drug safety assessments. Development Office of Management and Budget
of a general framework for biomarker (OMB) for review and approval. The ICR
Food and Drug Administration qualification will be discussed, along is for a 3-year extension for OMB
with specific application to different Control Number 4040–0010. The ICR
[Docket No. FDA–2016–N–0001]
COUs related to drug safety, including will expire on September 30, 2016. The
Developing an Evidentiary Standards consideration of several specific case 4040–0010 is composed of the following
Framework for Safety Biomarkers studies involving qualification of forms: Project Abstract; Project
Qualification; Public Workshop clinical markers of toxicity in different Performance Site Location(s); and Key
organ systems. Contacts. The ICR also requests
AGENCY: Food and Drug Administration, Registration: There is no fee to attend
categorizing these forms as common
HHS. the workshop, but attendees must
forms, meaning HHS will only request
ACTION: Notice of public workshop. register in advance. Space is limited,
approval for its own use of the form
and registration will be on a first-come,
SUMMARY: The Food and Drug rather than aggregating the burden
first-served basis. Persons interested in
Administration (FDA), in co- estimate across all Federal Agencies as
attending this workshop must register
sponsorship with the Foundation for the was done for previous actions on this
online at www.fnih.org/
National Institutes of Health Biomarkers OMB control number. Comments
evidentiarystandardsworkshop by April
Consortium (FNIH BC), is announcing a submitted during the first public review
1, 2016. For those persons without
of this ICR will be provided to OMB.
mstockstill on DSK4VPTVN1PROD with NOTICES

public workshop entitled ‘‘Developing Internet access, please contact Janelle
an Evidentiary Standards Framework for OMB will accept further comments from
Lewis at the Foundation for the NIH (see
Safety Biomarkers Qualification the public on this ICR during the review
FOR FURTHER INFORMATION CONTACT) to
Workshop.’’ The purpose of the and approval period.
register.
workshop is to discuss the evidentiary Attendees are responsible for their DATES: Comments on the ICR must be
standards needed to support biomarker own hotel accommodations. Attendees received on or before April 25, 2016.
qualification with a particular emphasis making reservations at the Bethesda ADDRESSES: Submit your comments to
on drug safety markers. The 2-day North Marriott Hotel and Conference ed.calimag@hhs.gov or (202) 690–7569.

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Document Created: 2018-02-02 14:35:40
Document Modified: 2018-02-02 14:35:40

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on the ICR must be received on or before April 25, 2016.
Contact		Information Collection Clearance staff, [email protected] or (202) 690-6162.
FR Citation		81 FR 9485

81 FR 9485 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 81, Issue 37 (February 25, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary