81 FR 35033 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 105 (June 1, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 105 (June 1, 2016)
| Page Range | 35033-35034 | |
| FR Document | 2016-12745 |
[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)] [Notices] [Pages 35033-35034] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12745] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than July 1, 2016. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for [[Page 35034]] HRSA, either by email to [email protected] or by fax to 202- 395-5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Rural Opioid Overdose Reversal Grant Program OMB No. 0906-xxxx--New. Abstract: This program is authorized by Section 711(b) of the Social Security Act (U.S.C. 912(b), as amended and the Consolidated and Further Continuing Appropriations Act (P.L. 113-235). The purpose of this grant program is to reduce the incidences of morbidity and mortality related to opioid overdoses in rural communities through the purchase and placement of emergency devices used to rapidly reverse the effects of opioid overdose and training of licensed healthcare professionals and emergency responders on their use. Need and Proposed Use of the Information: For this program, performance measures were drafted to provide data useful to the program and to enable HRSA to provide aggregate program data required by Congress under the Government Performance and Results Act (GPRA) of 1993 (Public Law 103-62). These measures cover the principal topic areas of interest to the Federal Office of Rural Health Policy, including: (a) The number of counties served by the program; (b) the number and type of devices purchased and distributed and the location of the distribution; (c) the number of training sessions and the number of individuals trained; and (d) the number of individuals who were administered Narcan and the outcome. These measures will speak to the Office's progress toward meeting the set goals. Likely Respondents: Rural Opioid Overdose Reversal Grant Program award recipients. 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 Average burden Form name Number of responses per Total per response Total burden respondents respondent responses (in hours) hours ---------------------------------------------------------------------------------------------------------------- Rural Opioid Overdose Reversal 18 1 18 4 72 Grant Program Performance Measures....................... ------------------------------------------------------------------------------- Total....................... 18 .............. 18 .............. 72 ---------------------------------------------------------------------------------------------------------------- Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016-12745 Filed 5-31-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices 35033
Food and Drug Administration, 10903 understanding regarding the Act of 1995 (44 U.S.C. 3501–3520). The
New Hampshire Ave., Bldg. 71, Rm. categorization of IDE devices. collections of information in 21 CFR
7301, Silver Spring, MD 20993–0002, On December 2, 2015, FDA’s CDRH part 812 have been approved under
240–402–7911. and CMS’s CAG executed an MOU to OMB control number 0910–0078. The
SUPPLEMENTARY INFORMATION: streamline and facilitate the efficient collections of information in 42 CFR
categorization of investigational medical part 405, subpart B have been approved
I. Background devices. The MOU will become effective under OMB control number 0938–1250.
FDA is announcing the availability of June 2, 2016. This guidance document
is intended to implement the MOU and V. Reference
a draft guidance for sponsors, clinical
investigators, industry, institutional describes the criteria that FDA intends The following reference is on display
review boards, and FDA staff, entitled to use to help determine the appropriate in the Division of Dockets Management
‘‘FDA Categorization of Investigational category for a device to be studied. This (see ADDRESSES) and is available for
Device Exemption (IDE) Devices to guidance document also describes a viewing by interested persons between
Assist the Centers for Medicare and pathway for changing the device 9 a.m. and 4 p.m., Monday through
Medicaid Services (CMS) with Coverage category from Category A to Category B. Friday; it are also available
Decisions.’’ When finalized, this draft electronically at http://
II. Significance of Guidance
guidance would modify FDA’s current www.regulations.gov. FDA has verified
This draft guidance is being issued the Web site address, as of the date this
policy on categorization of IDE devices. consistent with FDA’s good guidance
In September 1995, the Health Care document publishes in the Federal
practices regulation (21 CFR 10.115). Register, but Web sites are subject to
Financing Administration (now known The draft guidance, when finalized, will
as CMS) published a final rule and change over time.
represent the current thinking of FDA 1. Investigational Device Exemptions
entered into an Interagency Agreement on ‘‘FDA Categorization of (IDEs) for Early Feasibility Medical
(IA) with FDA regarding reimbursement Investigational Device Exemption (IDE) Device Clinical Studies, Including
categorization of investigational devices. Devices to Assist the Centers for Certain First in Human (FIH) Studies,
(60 FR 48417, September 19, 1995.) The Medicare and Medicaid Services (CMS) available at http://www.fda.gov/
rule at 42 CFR part 405, subpart B with Coverage Decisions.’’ It does not downloads/medicaldevices/device
established that certain devices with an establish any rights for any person and regulationandguidance/
IDE approved by FDA (and certain is not binding on FDA or the public. guidancedocuments/ucm279103.pdf.
services related to those devices) may be You can use an alternative approach if
covered under Medicare, and set forth Dated: May 25, 2016.
it satisfies the requirements of the
the process by which FDA would assist Leslie Kux,
applicable statutes and regulations.
CMS in identifying such devices. FDA Associate Commissioner for Policy.
would assign a device with an FDA III. Electronic Access [FR Doc. 2016–12828 Filed 5–31–16; 8:45 am]
approved IDE to one of two categories: Persons interested in obtaining a copy BILLING CODE 4164–01–P
Experimental/Investigational (Category of the draft guidance may do so by
A) devices or Non-experimental/ downloading an electronic copy from
Investigational (Category B) devices the Internet. A search capability for all DEPARTMENT OF HEALTH AND
based on the level of risk the device Center for Devices and Radiological HUMAN SERVICES
presented to patients. The IA set forth Health guidance documents is available
criteria, agreed upon by CMS and FDA, Health Resources and Services
at http://www.fda.gov/MedicalDevices/
which FDA would use to categorize Administration
DeviceRegulationandGuidance/
devices. The categorization would then GuidanceDocuments/default.htm. Agency Information Collection
be used by CMS as part of its Guidance documents are also available Activities: Submission to OMB for
determination of whether or not devices at http://www.fda.gov/BiologicsBlood Review and Approval; Public Comment
met the requirements for Medicare Vaccines/GuidanceCompliance Request
coverage under section 1862(a)(1)(A) of RegulatoryInformation/Guidances/
the Social Security Act (42 U.S.C. default.htm or http:// AGENCY: Health Resources and Services
1385y). CMS and FDA both recognized www.regulations.gov. Persons unable to Administration, HHS.
that experience in categorizing devices download an electronic copy of ‘‘FDA ACTION: Notice.
might require changes to the Interagency Categorization of Investigational Device
Agreement. Exemption (IDE) Devices to Assist the SUMMARY: In compliance with Section
In the more than 20 years since the IA Centers for Medicare and Medicaid 3507(a)(1)(D) of the Paperwork
was signed, FDA has received a number Services (CMS) with Coverage Reduction Act of 1995, the Health
of IDEs which do not easily fit into any Decisions’’ may send an email request to Resources and Services Administration
of the eight subcategories identified in CDRH-Guidance@fda.hhs.gov to receive (HRSA) has submitted an Information
the IA. There have been several an electronic copy of the document. Collection Request (ICR) to the Office of
developments, such as: The publication Please use the document number 16001 Management and Budget (OMB) for
of the guidance document entitled to identify the guidance you are review and approval. Comments
‘‘Investigational Device Exemptions requesting. submitted during the first public review
(IDEs) for Early Feasibility Medical of this ICR will be provided to OMB.
Device Clinical Studies, Including IV. Paperwork Reduction Act of 1995 OMB will accept further comments from
sradovich on DSK3TPTVN1PROD with NOTICES
Certain First in Human (FIH) Studies;’’ This draft guidance refers to the public during the review and
(Ref. 1) and a subsequent increase in previously approved collections of approval period.
submission of early feasibility studies to information found in FDA and CMS DATES: Comments on this ICR should be
FDA, as well as modifications to CMS’s regulations. These collections of received no later than July 1, 2016.
regulation regarding IDEs (42 CFR part information are subject to review by the ADDRESSES: Submit your comments,
405, subpart B), which have prompted Office of Management and Budget including the Information Collection
FDA and CMS to revise their shared (OMB) under the Paperwork Reduction Request Title, to the desk officer for
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![35034 Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices
HRSA, either by email to OIRA_ opioid overdose and training of licensed Likely Respondents: Rural Opioid
submission@omb.eop.gov or by fax to healthcare professionals and emergency Overdose Reversal Grant Program award
202–395–5806. responders on their use. recipients.
FOR FURTHER INFORMATION CONTACT: To
Need and Proposed Use of the
Burden Statement: Burden in this
request a copy of the clearance requests Information: For this program,
performance measures were drafted to context means the time expended by
submitted to OMB for review, email the persons to generate, maintain, retain,
HRSA Information Collection Clearance provide data useful to the program and
to enable HRSA to provide aggregate disclose or provide the information
Officer at paperwork@hrsa.gov or call requested. This includes the time
(301) 443–1984. program data required by Congress
under the Government Performance and needed to review instructions; to
SUPPLEMENTARY INFORMATION: Results Act (GPRA) of 1993 (Public Law develop, acquire, install and utilize
Information Collection Request Title: 103–62). These measures cover the technology and systems for the purpose
Rural Opioid Overdose Reversal Grant principal topic areas of interest to the of collecting, validating and verifying
Program OMB No. 0906–xxxx—New. Federal Office of Rural Health Policy, information, processing and
Abstract: This program is authorized including: (a) The number of counties maintaining information, and disclosing
by Section 711(b) of the Social Security served by the program; (b) the number and providing information; to train
Act (U.S.C. 912(b), as amended and the and type of devices purchased and personnel and to be able to respond to
Consolidated and Further Continuing distributed and the location of the a collection of information; to search
Appropriations Act (P.L. 113–235). The distribution; (c) the number of training data sources; to complete and review
purpose of this grant program is to sessions and the number of individuals the collection of information; and to
reduce the incidences of morbidity and trained; and (d) the number of transmit or otherwise disclose the
mortality related to opioid overdoses in individuals who were administered information. The total annual burden
rural communities through the purchase Narcan and the outcome. These hours estimated for this ICR are
and placement of emergency devices measures will speak to the Office’s summarized in the table below.
used to rapidly reverse the effects of progress toward meeting the set goals.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Rural Opioid Overdose Reversal Grant Program Perform-
ance Measures ................................................................. 18 1 18 4 72
Total .............................................................................. 18 ........................ 18 ........................ 72
Jason E. Bennett, Name of Committee: Heart, Lung, and DEPARTMENT OF HEALTH AND
Director, Division of the Executive Secretariat. Blood Initial Review Group; Clinical Trials HUMAN SERVICES
[FR Doc. 2016–12745 Filed 5–31–16; 8:45 am] Review Committee.
BILLING CODE 4165–15–P
Date: June 23–24, 2016. National Institutes of Health
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant National Heart, Lung, and Blood
DEPARTMENT OF HEALTH AND applications. Institute; Notice of Closed Meeting
HUMAN SERVICES Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814. Pursuant to section 10(d) of the
National Institutes of Health Contact Person: Keary A. Cope, Ph.D., Federal Advisory Committee Act, as
Scientific Review Officer, Office of Scientific amended (5 U.S.C. App.), notice is
National Heart, Lung, and Blood Review/DERA, National Heart, Lung, and hereby given of the following meeting.
Institute; Notice of Closed Meeting Blood Institute, 6701 Rockledge Drive, Room The meeting will be closed to the
7190, Bethesda, MD 20892–7924, 301–435– public in accordance with the
Pursuant to section 10(d) of the 2222, copeka@mail.nih.gov. provisions set forth in sections
Federal Advisory Committee Act, as (Catalogue of Federal Domestic Assistance 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
amended (5 U.S.C. App.), notice is Program Nos. 93.233, National Center for as amended. The grant applications and
hereby given of the following meeting. Sleep Disorders Research; 93.837, Heart and the discussions could disclose
The meeting will be closed to the Vascular Diseases Research; 93.838, Lung confidential trade secrets or commercial
public in accordance with the Diseases Research; 93.839, Blood Diseases property such as patentable material,
provisions set forth in sections and Resources Research, National Institutes and personal information concerning
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., of Health, HHS) individuals associated with the grant
as amended. The grant applications and Dated: May 25, 2016. applications, the disclosure of which
the discussions could disclose
sradovich on DSK3TPTVN1PROD with NOTICES
Michelle Trout, would constitute a clearly unwarranted
confidential trade secrets or commercial invasion of personal privacy.
property such as patentable material, Program Analyst, Office of Federal Advisory
Committee Policy. Name of Committee: Heart, Lung, and
and personal information concerning Blood Initial Review Group; NHLBI
individuals associated with the grant [FR Doc. 2016–12756 Filed 5–31–16; 8:45 am]
Mentored Clinical and Basic Science Review
applications, the disclosure of which BILLING CODE 4140–01–P Committee.
would constitute a clearly unwarranted Date: June 23–24, 2016.
invasion of personal privacy. Time: 10:30 a.m. to 11:00 a.m.
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Document Created: 2018-02-08 07:27:14
Document Modified: 2018-02-08 07:27:14
| 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 this ICR should be received no later than July 1, 2016. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 81 FR 35033 |
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