Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 35033-35034 [2016-12745]
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Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3TPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for sponsors, clinical
investigators, industry, institutional
review boards, and FDA staff, entitled
‘‘FDA Categorization of Investigational
Device Exemption (IDE) Devices to
Assist the Centers for Medicare and
Medicaid Services (CMS) with Coverage
Decisions.’’ When finalized, this draft
guidance would modify FDA’s current
policy on categorization of IDE devices.
In September 1995, the Health Care
Financing Administration (now known
as CMS) published a final rule and
entered into an Interagency Agreement
(IA) with FDA regarding reimbursement
categorization of investigational devices.
(60 FR 48417, September 19, 1995.) The
rule at 42 CFR part 405, subpart B
established that certain devices with an
IDE approved by FDA (and certain
services related to those devices) may be
covered under Medicare, and set forth
the process by which FDA would assist
CMS in identifying such devices. FDA
would assign a device with an FDA
approved IDE to one of two categories:
Experimental/Investigational (Category
A) devices or Non-experimental/
Investigational (Category B) devices
based on the level of risk the device
presented to patients. The IA set forth
criteria, agreed upon by CMS and FDA,
which FDA would use to categorize
devices. The categorization would then
be used by CMS as part of its
determination of whether or not devices
met the requirements for Medicare
coverage under section 1862(a)(1)(A) of
the Social Security Act (42 U.S.C.
1385y). CMS and FDA both recognized
that experience in categorizing devices
might require changes to the Interagency
Agreement.
In the more than 20 years since the IA
was signed, FDA has received a number
of IDEs which do not easily fit into any
of the eight subcategories identified in
the IA. There have been several
developments, such as: The publication
of the guidance document entitled
‘‘Investigational Device Exemptions
(IDEs) for Early Feasibility Medical
Device Clinical Studies, Including
Certain First in Human (FIH) Studies;’’
(Ref. 1) and a subsequent increase in
submission of early feasibility studies to
FDA, as well as modifications to CMS’s
regulation regarding IDEs (42 CFR part
405, subpart B), which have prompted
FDA and CMS to revise their shared
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21:59 May 31, 2016
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understanding regarding the
categorization of IDE devices.
On December 2, 2015, FDA’s CDRH
and CMS’s CAG executed an MOU to
streamline and facilitate the efficient
categorization of investigational medical
devices. The MOU will become effective
June 2, 2016. This guidance document
is intended to implement the MOU and
describes the criteria that FDA intends
to use to help determine the appropriate
category for a device to be studied. This
guidance document also describes a
pathway for changing the device
category from Category A to Category B.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘FDA Categorization of
Investigational Device Exemption (IDE)
Devices to Assist the Centers for
Medicare and Medicaid Services (CMS)
with Coverage Decisions.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Persons unable to
download an electronic copy of ‘‘FDA
Categorization of Investigational Device
Exemption (IDE) Devices to Assist the
Centers for Medicare and Medicaid
Services (CMS) with Coverage
Decisions’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number 16001
to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA and CMS
regulations. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
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35033
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078. The
collections of information in 42 CFR
part 405, subpart B have been approved
under OMB control number 0938–1250.
V. Reference
The following reference is on display
in the Division of Dockets Management
(see ADDRESSES) and is available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; it are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site address, as of the date this
document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. Investigational Device Exemptions
(IDEs) for Early Feasibility Medical
Device Clinical Studies, Including
Certain First in Human (FIH) Studies,
available at https://www.fda.gov/
downloads/medicaldevices/device
regulationandguidance/
guidancedocuments/ucm279103.pdf.
Dated: May 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12828 Filed 5–31–16; 8:45 am]
BILLING CODE 4164–01–P
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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
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
SUMMARY:
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35034
Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices
HRSA, either by email to OIRA_
submission@omb.eop.gov 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 paperwork@hrsa.gov 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
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Rural Opioid Overdose Reversal Grant Program Performance Measures .................................................................
18
1
18
4
72
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3TPTVN1PROD with NOTICES
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
VerDate Sep<11>2014
21:59 May 31, 2016
Jkt 238001
Name of Committee: Heart, Lung, and
Blood Initial Review Group; Clinical Trials
Review Committee.
Date: June 23–24, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Keary A. Cope, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7190, Bethesda, MD 20892–7924, 301–435–
2222, copeka@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: May 25, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–12756 Filed 5–31–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Heart, Lung, and
Blood Initial Review Group; NHLBI
Mentored Clinical and Basic Science Review
Committee.
Date: June 23–24, 2016.
Time: 10:30 a.m. to 11:00 a.m.
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]]>Agencies
[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)]
[Notices]
[Pages 35033-35034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov 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
