82 FR 12615 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 82, Issue 42 (March 6, 2017)

Page Range		12615-12615
FR Document		2017-04249

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0278, which expires on August 31, 2017. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Federal Register, Volume 82 Issue 42 (Monday, March 6, 2017)

[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Page 12615]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: 0990-0278-60D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary (OS), Department of 
Health and Human Services, announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). The ICR is for extending the use of the approved 
information collection assigned OMB control number 0990-0278, which 
expires on August 31, 2017. Prior to submitting the ICR to OMB, OS 
seeks comments from the public regarding the burden estimate, below, or 
any other aspect of the ICR.

DATES: Comments on the ICR must be received on or before May 5, 2017.

ADDRESSES: Submit your comments to 
[email protected] and [email protected] or 
by calling (202) 795-7714.
    Information Collection Request Title: Federal-wide Assurance Forms.
    Abstract: Assistant Secretary for Health, Office for Human Research 
Protections is requesting Office of Management and Budget, OMB approval 
on a three year extension of the Federal-wide Assurance (FWA). The FWA 
is designed to provide a simplified procedure for institutions engaged 
in HHS-conducted or supported research to satisfy the assurance 
requirements of Section 491(a) of the Public Health Service Act and HHS 
Regulations for the protection of human subjects at 45 CFR 46.103. The 
respondents are institutions engaged in human subject research that is 
conducted or supported by HHS.
    Need and Proposed Use of the Information: OHRP is the HHS component 
charged with fulfilling the statutory mandates of these provisions of 
the PHS Act and enforcing HHS regulations at 45 CFR part 46. The FWA 
provides a simplified assurance process that replaced the prior 
assurance mechanisms used by OHRP, all of which were more complicated 
and burdensome than the FWA. The information collected by OHRP through 
the FWA is the minimum necessary to satisfy the assurance requirements 
of the PHS Act and the requirements of HHS regulations at 45 CFR 
46.103.
    Likely Respondents: Individuals or households, business or other 
for-profit, not-for-profit institutions, Federal, State, Local, or 
Tribal Governments.
    The total annual burden hours estimated for this ICR are summarized 
in the table below.

                                   Estimated Annualized Burden in Hours Table
----------------------------------------------------------------------------------------------------------------
                                                                  Number of
                  Form name                      Number of      responses  per     Hours per         Response
                                                respondents       respondent        response       burden hours
----------------------------------------------------------------------------------------------------------------
Federal-wide Assurance (FWA)................          14,000              2.0             0.50           14,000
----------------------------------------------------------------------------------------------------------------

    OS 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.

Terry S. Clark,
Asst. Information Collection Clearance Officer.
[FR Doc. 2017-04249 Filed 3-3-17; 8:45 am]
 BILLING CODE 4150-28-P

Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices 12615

October 2016. It is anticipated that thereafter, will continue to be accessible ADDRESSES: Submit your comments to
future meetings will be held in the third online and upon request at the Office of Information.CollectionClearance@
weeks of July 2017 and October 2017. Disease Prevention and Health hhs.gov and Sherrette.Funn@hhs.gov or
Meeting dates, times, locations, and Promotion, OASH/HHS; 1101 Wootton by calling (202) 795–7714.
other relevant information will be Parkway, Suite LL100 Tower Building; Information Collection Request Title:
announced at least 15 days in advance Rockville, MD 20852; Telephone: (240) Federal-wide Assurance Forms.
of each meeting via Federal Register 453–8280; Fax: (240) 453–8281. Abstract: Assistant Secretary for
notice. As stipulated in the charter, the Dated: February 23, 2017. Health, Office for Human Research
Committee will be terminated after Don Wright, Protections is requesting Office of
delivery of its report to the Secretary of Management and Budget, OMB approval
Deputy Assistant Secretary for Health,
HHS or two years from the date the Disease Prevention and Health Promotion. on a three year extension of the Federal-
charter was filed, whichever comes first. wide Assurance (FWA). The FWA is
[FR Doc. 2017–04170 Filed 3–3–17; 8:45 am]
Purpose of the Meeting: In accordance designed to provide a simplified
BILLING CODE 4150–32–P
with FACA and to promote procedure for institutions engaged in
transparency of the process, HHS-conducted or supported research
deliberations of the Committee will to satisfy the assurance requirements of
DEPARTMENT OF HEALTH AND
occur in a public forum. At this Section 491(a) of the Public Health
HUMAN SERVICES
meeting, the Committee will continue Service Act and HHS Regulations for the
its deliberations from the last public Office of the Secretary protection of human subjects at 45 CFR
meeting.
[Document Identifier: 0990–0278–60D] 46.103. The respondents are institutions
Meeting Agenda: The meeting will
engaged in human subject research that
include review of subcommittee work
since the last public meeting and Agency Information Collection is conducted or supported by HHS.
deliberation by the full Committee, Activities; Proposed Collection; Public Need and Proposed Use of the
discussion of overarching issues, and Comment Request Information: OHRP is the HHS
plans for future Committee work. component charged with fulfilling the
AGENCY: Office of the Secretary, HHS.
Meeting Registration: The meeting is statutory mandates of these provisions
ACTION: Notice. of the PHS Act and enforcing HHS
open to the public via videocast; pre-
registration is required. To register, SUMMARY: In compliance with section regulations at 45 CFR part 46. The FWA
please visit www.health.gov/ 3506(c)(2)(A) of the Paperwork provides a simplified assurance process
paguidelines. After registration, Reduction Act of 1995, the Office of the that replaced the prior assurance
individuals will receive videocast Secretary (OS), Department of Health mechanisms used by OHRP, all of
access information via email. To request and Human Services, announces plans which were more complicated and
a special accommodation, please email to submit an Information Collection burdensome than the FWA. The
jennifer.gillissen@kauffmaninc.com. Request (ICR), described below, to the information collected by OHRP through
Public Comments and Meeting Office of Management and Budget the FWA is the minimum necessary to
Documents: Written comments from the (OMB). The ICR is for extending the use satisfy the assurance requirements of the
public will be accepted throughout the of the approved information collection PHS Act and the requirements of HHS
Committee’s deliberative process and assigned OMB control number 0990– regulations at 45 CFR 46.103.
can be submitted and/or viewed at 0278, which expires on August 31, Likely Respondents: Individuals or
www.health.gov/paguidelines/pcd/. 2017. Prior to submitting the ICR to households, business or other for-profit,
Documents pertaining to Committee OMB, OS seeks comments from the not-for-profit institutions, Federal, State,
deliberations, including meeting public regarding the burden estimate, Local, or Tribal Governments.
agendas and summaries will be below, or any other aspect of the ICR. The total annual burden hours
available on www.health.gov/ DATES: Comments on the ICR must be estimated for this ICR are summarized
paguidelines. Meeting information, received on or before May 5, 2017. in the table below.

ESTIMATED ANNUALIZED BURDEN IN HOURS TABLE
Number of
Number of responses Hours per Response
Form name respondents per response burden hours
respondent

Federal-wide Assurance (FWA) ....................................................................... 14,000 2.0 0.50 14,000

OS specifically requests comments on technology to minimize the information DEPARTMENT OF HEALTH AND
(1) the necessity and utility of the collection burden. HUMAN SERVICES
proposed information collection for the
Terry S. Clark, National Institutes of Health
proper performance of the agency’s
asabaliauskas on DSK3SPTVN1PROD with NOTICES

functions, (2) the accuracy of the Asst. Information Collection Clearance
Officer. Eunice Kennedy Shriver National
estimated burden, (3) ways to enhance
[FR Doc. 2017–04249 Filed 3–3–17; 8:45 am] Institute of Child Health & Human
the quality, utility, and clarity of the
BILLING CODE 4150–28–P
Development; Amended Notice of
information to be collected, and (4) the Meeting
use of automated collection techniques
or other forms of information Notice is hereby given of a change in
the meeting of the National Institute of
Child Health and Human Development

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Document Created: 2017-03-04 00:06:29
Document Modified: 2017-03-04 00:06:29

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 May 5, 2017.
FR Citation		82 FR 12615

82 FR 12615 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 82, Issue 42 (March 6, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary