80 FR 67412 - Agency Information Collection Activities; Proposed Collection; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 211 (November 2, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 211 (November 2, 2015)
| Page Range | 67412-67413 | |
| FR Document | 2015-27860 |
[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)] [Notices] [Pages 67412-67413] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27860] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: HHS-OS-4040-New-60D] Agency Information Collection Activities; Proposed Collection; Public Comment Request AGENCY: Office of the Secretary, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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 a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). 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 January 4, 2016. ADDRESSES: Submit your comments to Information.CollectionClearance@hhs.gov or by calling (202) 690-6162. 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 document identifier HHS-OS-4040-New-60D for reference. Information Collection Request Title: DATA Act Sec. 5. ``Simplifying Federal Award Reporting'' Grants Pilot. Abstract: Public Law 113-101, The Digital Accountability and Transparency Act of 2014 (DATA Act) expands the Federal Funding Accountability and Transparency Act of 2006 by increasing accountability and transparency in Federal spending. Section 5 of the DATA Act (``Sec. 5. Simplifying Federal Award Reporting'') tasks the Director of the Office of Management and Budget (OMB) to establish a pilot program (Sec. 5 (b)). OMB has designated the Department of Health and Human Services (HHS) as the executing agent of the pilot program. Within HHS, the DATA Act Program Management Office (PMO) (DAP) has been established under the Office of the [[Page 67413]] Assistant Secretary for Financial Resources (ASFR) in order to implement this pilot program. ASFR/DAP, in coordination with Grants.gov, is requesting a generic clearance for the purpose of conducting tests under the pilot program to obtain qualitative and quantitative data and gain an understanding of the burden imposed on Federal recipients. The DAP has designed several test models to evaluate recipient burden and assess quality of data. The goal of these test models is to determine whether new technology, data standards, processes, and forms aid in reducing recipient burden and increase the accuracy and quality of the data submitted. Under this clearance, a variety of methods (surveys, focus groups, etc.) could be used to collect data, with the exact nature of the questions currently undetermined. DAP expects these questions to include, but not be limited to, topics pertaining to the Standard Form (SF) 424, the Consolidated Federal Financial Reports, and the expanded Single Audit form (SF-SAC). If this data is not collected, the requirements of the DATA Act Section 5 pilot will not be met. The types of collections that this generic clearance covers include, but are not limited to:Surveys, Focus Groups, Other qualitative methods such as interviews, small discussion groups, and case studies. Likely Respondents: Recipients of Federal contracts, grants, and sub-awards. Total Estimated Annualized Burden--Hours ---------------------------------------------------------------------------------------------------------------- Estimated annual reporting burden ----------------------------------------------------------------------------------------------------------------- Annual Type of collection Number of frequency per Hours per Total hours respondents response response ---------------------------------------------------------------------------------------------------------------- Surveys, Focus Groups, and other qualitative 300 1 56.25 16,875 methods...................................... ----------------------------------------------------------------- Total..................................... 300 ............... ............... 16,875 ---------------------------------------------------------------------------------------------------------------- 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. Darius Taylor, Information Collection Clearance Officer. [FR Doc. 2015-27860 Filed 10-30-15; 8:45 am] BILLING CODE 4150-37-P
![67412 Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices
FOR FURTHER INFORMATION CONTACT: II. Significance of Guidance Dated: October 27, 2015.
Donald Witters, Center for Devices and This draft guidance is being issued Leslie Kux,
Radiological Health, Food and Drug consistent with FDA’s good guidance Associate Commissioner for Policy.
Administration, 10903 New Hampshire practices regulation (21 CFR 10.115). [FR Doc. 2015–27818 Filed 10–30–15; 8:45 am]
Ave. Bldg. 62, Rm. 1130, Silver Spring, The draft guidance, when finalized, will BILLING CODE 4164–01–P
MD 20993–0002, 301–796–2483. represent the current thinking of FDA
SUPPLEMENTARY INFORMATION: on information that should be provided
to support claims of electromagnetic DEPARTMENT OF HEALTH AND
I. Background compatibility of electrically powered HUMAN SERVICES
medical devices. It does not establish
FDA is announcing the availability of Office of the Secretary
any rights for any person and is not
a draft guidance to provide FDA’s
binding on FDA or the public. You can [Document Identifier: HHS–OS–4040–New–
current thinking on the types of use an alternative approach if it satisfies 60D]
information that should be provided in the requirements of the applicable
a premarket submission to support a statute and regulations. Agency Information Collection
claim of electromagnetic compatibility Activities; Proposed Collection; Public
for an electrically powered medical III. Electronic Access Comment Request
device. EMI is a hazard with associated Persons interested in obtaining a copy
risk for electrically powered medical AGENCY: Office of the Secretary, HHS.
of the draft guidance may do so by
devices. EMC assessment can help to ACTION: Notice.
downloading an electronic copy from
ensure that the risks associated with the Internet. A search capability for all SUMMARY: In compliance with section
performance degradation of electrically Center for Devices and Radiological 3506(c)(2)(A) of the Paperwork
powered medical devices due to EMI are Health guidance documents is available Reduction Act of 1995, the Office of the
adequately mitigated. at http://www.fda.gov/MedicalDevices/ Secretary (OS), Department of Health
The draft guidance includes DeviceRegulationandGuidance/ and Human Services, announces plans
information consistent with GuidanceDocuments/default.htm. to submit a new Information Collection
specifications described in FDA- Guidance documents are also available Request (ICR), described below, to the
recognized consensus national or at http://www.regulations.gov. Persons Office of Management and Budget
international standards for EMC such as unable to download an electronic copy (OMB). Prior to submitting the ICR to
in the International Electrotechnical of ‘‘Information to Support a Claim of OMB, OS seeks comments from the
Commission (IEC) 60601–1–2: Edition 3: Electromagnetic Compatibility (EMC) of public regarding the burden estimate,
2007–03, Medical Electrical Electrically-Powered Medical Devices’’ below, or any other aspect of the ICR.
Equipment—Part 1–2: General may send an email request to CDRH- DATES: Comments on the ICR must be
Requirements for Basic Safety and Guidance@fda.hhs.gov to receive an received on or before January 4, 2016.
Essential Performance—Collateral electronic copy of the document. Please
ADDRESSES: Submit your comments to
Standard: Electromagnetic use the document number 1400057 to
identify the guidance you are Information.CollectionClearance@
Compatibility—Requirements and Tests; hhs.gov or by calling (202) 690–6162.
requesting.
IEC 60601–1–2: Edition 4.0: 2014–01, FOR FURTHER INFORMATION CONTACT:
Medical Electrical Equipment, Part 1–2: IV. Paperwork Reduction Act of 1995 Information Collection Clearance staff,
General Requirements for Basic Safety This draft guidance refers to Information.CollectionClearance@
and Essential Performance—Collateral previously approved collections of hhs.gov or (202) 690–6162.
Standard: Electromagnetic information found in FDA regulations. SUPPLEMENTARY INFORMATION: When
Disturbances—Requirements and Tests; These collections of information are submitting comments or requesting
Association for the Advancement of subject to review by the Office of information, please include the
Medical Instrumentation (AAMI)/ Management and Budget (OMB) under document identifier HHS–OS–4040–
American National Standards Institute the Paperwork Reduction Act of 1995 New–60D for reference.
(ANSI)/IEC 60601–1–2: 2007/(R) 2012 (44 U.S.C. 3501–3520). The collections Information Collection Request Title:
Medical Electrical Equipment—Part 1– of information in 21 CFR part 814 have DATA Act Sec. 5. ‘‘Simplifying Federal
2: General Requirements for Basic Safety been approved under OMB control Award Reporting’’ Grants Pilot.
and Essential Performance—Collateral number 0910–0231. The collections of Abstract: Public Law 113–101, The
Standard: Electromagnetic information in 21 CFR part 807, subpart Digital Accountability and
Compatibility—Requirements and Tests; E have been approved under OMB Transparency Act of 2014 (DATA Act)
and AAMI/ANSI/IEC 60601–1–2: 2014, control number 0910–0120. The expands the Federal Funding
Medical Electrical Equipment—Part 1– collections of information in 21 CFR Accountability and Transparency Act of
2: General Requirements for Basic Safety part 812 have been approved under 2006 by increasing accountability and
and Essential Performance—Collateral OMB control number 0910–0078. The transparency in Federal spending.
Standard: Electromagnetic collections of information in 21 CFR Section 5 of the DATA Act (‘‘Sec. 5.
Disturbances—Requirements and Tests part 814, subpart H have been approved Simplifying Federal Award Reporting’’)
Standards that sponsors and under OMB control number 0910–0332. tasks the Director of the Office of
asabaliauskas on DSK5VPTVN1PROD with NOTICES
manufacturers of electrically powered The collections of information in Management and Budget (OMB) to
medical devices often reference. This sections 520(m) and 515A of the Federal establish a pilot program (Sec. 5 (b)).
draft guidance is intended to help Food, Drug, and Cosmetic Act (21 U.S.C. OMB has designated the Department
ensure that clear and consistent 360j and 21 U.S.C. 360e–1, respectively) of Health and Human Services (HHS) as
information is provided in premarket and 613(b) of Food and Drug the executing agent of the pilot program.
submissions regarding medical device Administration Safety and Innovation Within HHS, the DATA Act Program
EMC and to facilitate the review of Act have been approved under OMB Management Office (PMO) (DAP) has
submissions with EMC claims. control number 0910–0661. been established under the Office of the
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![Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices 67413
Assistant Secretary for Financial technology, data standards, processes, the requirements of the DATA Act
Resources (ASFR) in order to implement and forms aid in reducing recipient Section 5 pilot will not be met. The
this pilot program. ASFR/DAP, in burden and increase the accuracy and types of collections that this generic
coordination with Grants.gov, is quality of the data submitted. Under this clearance covers include, but are not
requesting a generic clearance for the clearance, a variety of methods (surveys, limited to:
purpose of conducting tests under the focus groups, etc.) could be used to • Surveys,
pilot program to obtain qualitative and collect data, with the exact nature of the
• Focus Groups,
quantitative data and gain an questions currently undetermined. DAP
understanding of the burden imposed expects these questions to include, but • Other qualitative methods such as
on Federal recipients. not be limited to, topics pertaining to interviews, small discussion groups,
The DAP has designed several test the Standard Form (SF) 424, the and case studies.
models to evaluate recipient burden and Consolidated Federal Financial Reports, Likely Respondents: Recipients of
assess quality of data. The goal of these and the expanded Single Audit form Federal contracts, grants, and sub-
test models is to determine whether new (SF–SAC). If this data is not collected, awards.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Estimated annual reporting burden
Annual
Number of Hours per
Type of collection frequency per Total hours
respondents response
response
Surveys, Focus Groups, and other qualitative methods ................................. 300 1 56.25 16,875
Total .......................................................................................................... 300 ........................ ........................ 16,875
OS specifically requests comments on DATES: The comment period for the FOR FURTHER INFORMATION CONTACT: Carl
(1) the necessity and utility of the notice published in the Federal Register Harper, Director, Office of Resource
proposed information collection for the on August 24, 2015 (80 FR 51281) Access and Partnerships, Indian Health
proper performance of the agency’s allowed for thirty days; the comment Service, 801 Thompson Avenue,
functions, (2) the accuracy of the period was subsequently extended in Rockville, Maryland 20852. Telephone:
estimated burden, (3) ways to enhance the Federal Register (80 FR 60158) for (301) 443–1553.
the quality, utility, and clarity of the an additional 30 days to October 23,
information to be collected, and (4) the 2015. This notice extends the comment SUPPLEMENTARY INFORMATION: The notice
use of automated collection techniques period for an additional 30 days to that was published in the Federal
or other forms of information November 22, 2015. Register on August 24, 2015 advises the
technology to minimize the information ADDRESSES: Because of staff and public that the Indian Health Service
collection burden. resource limitations, we cannot accept proposes to expand the geographic
comments by facsimile transmission. boundaries of the Service Delivery Area
Darius Taylor, for the Wampanoag Tribe of Gay Head
You may submit comments in one of
Information Collection Clearance Officer. (Aquinnah) of Massachusetts. The
three ways (please choose only one of
[FR Doc. 2015–27860 Filed 10–30–15; 8:45 am] the ways listed): Aquinnah service delivery area is
BILLING CODE 4150–37–P 1. By regular mail. You may mail currently comprised of members of the
written comments to the following Tribe residing in Martha’s Vineyard,
address ONLY: Betty Gould, Regulations Dukes County in the State of
DEPARTMENT OF HEALTH AND Officer, Indian Health Service, 801 Massachusetts.
HUMAN SERVICES Thompson, Avenue, TMP STE 450, The Bureau of Indian Affairs
Rockville, Maryland 20852. recognized the Wampanoag Tribe of Gay
Indian Health Service Please allow sufficient time for mailed Head on February 10, 1987. Martha’s
Notice To Propose the Redesignation comments to be received before the Vineyard, Dukes County was designated
of the Service Delivery Area for the close of the comment period. as the Aquinnah service delivery area in
2. By express or overnight mail. You
Wampanoag Tribe of Gay Head the Wampanoag Tribal Council of Gay
may send written comments to the
(Aquinnah) Head, Inc., Indian Claims Settlement
above address.
3. By hand or courier. If you prefer, Act of 1987, Public Law 100–95.
Indian Health Service, HHS.
AGENCY:
Notice; extension of the
ACTION: you may deliver (by hand or courier) This comment period is being
comment period. your written comments before the close extended to allow all interested parties
of the comment period to the address the opportunity to comment on the
SUMMARY: This document extends the above. If you intend to deliver your proposed rule. Therefore, we are
comment period for the notice to comments to the Rockville address, extending the comment period until
asabaliauskas on DSK5VPTVN1PROD with NOTICES
propose Redesignation of the Service please call telephone number (301) 443– November 22, 2015.
Delivery Area for the Wampanoag Tribe 1116 in advance to schedule your Dated: October 23, 2015.
of Gay Head (Aquinnah), which was arrival with a staff member.
published in the Federal Register on Comments will be made available for Robert G. McSwain,
October 5, 2015. The comment period public inspection at the Rockville Principal Deputy Director, Indian Health
for the notice, which would have ended address from 8:30 a.m. to 5:00 p.m., Service.
on October 23, 2015, is extended by 30 Monday–Friday, approximately three [FR Doc. 2015–27898 Filed 10–30–15; 8:45 am]
days. weeks after publication of this notice. BILLING CODE 4165–16–P
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Document Created: 2018-03-01 11:29:52
Document Modified: 2018-03-01 11:29:52
| 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 January 4, 2016. | |
| Contact | Information Collection Clearance staff, [email protected] or (202) 690-6162. | |
| FR Citation | 80 FR 67412 |
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