Agency Information Collection Activities: Submission for OMB Review; Comment Request, 49611-49612 [2017-23341]
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Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices
Scoville, Idaho), Area IV of Santa
Susanna Field Laboratory (1991–1993;
Ventura County, California), Ames
Laboratory (1971—undetermined
ending date; Ames, Iowa); and Board
Work Sessions. Agenda items are
subject to change as priorities dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2017–23333 Filed 10–25–17; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)—State, Tribal, Local
and Territorial (STLT) Subcommittee
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
Centers for Disease Control and
Prevention (CDC), announces the
following meeting for the State, Tribal,
Local and Territorial Subcommittee,
Centers for Disease Control and
Prevention (STLT, CDC). This meeting
is open to the public, limited only by
100 ports for audio phone lines access
available. The public is also welcome to
listen to the meeting by (866) 917–2712,
passcode 9418625. The public comment
period is from 03:50 p.m.–03:55 p.m.
EST. Please register for public comment
by December 8, 2017 via email to
acdirector@cdc.gov.
DATES: The meeting will be held on
December 18, 2017, 2:30 p.m. to 4:00
p.m., EST.
ADDRESSES: Audio Line Access Only
(866) 917–2712, passcode 9418625.
FOR FURTHER INFORMATION CONTACT: Jose
Montero, MD, MPH, Director, Office for
State, Tribal, Local and Territorial
Support, CDC, 4770 Buford Highway,
Mailstop E70, Atlanta, Georgia 30341,
(404) 498–0300, ostltsdirector@cdc.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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Purpose: The Subcommittee will
provide counsel to the ACD, CDC on
strategies, future needs, and challenges
faced by State, Tribal, Local and
Territorial health agencies, and will
provide guidance on opportunities for
CDC through the ACD.
Matters To Be Considered: The agenda
will include discussions on
implementation of ACD-adopted
recommendations related to the health
department of the future, additional
developments that may expand these
recommendations, and how CDC can
best support STLT health departments.
Agenda items are subject to change as
priorities dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2017–23334 Filed 10–25–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10114 and
CMS–417]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
SUMMARY:
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49611
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments on the collection(s) of
information must be received by the
OMB desk officer by November 27,
2017.
DATES:
When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
Web site address at https://
www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
ADDRESSES:
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49612
Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection;
Title of Information Collection:
National Provider Identifier (NPI)
Application and Update Form and
Supporting Regulations in 45 CFR
142.408, 45 CFR 162.406, 45 CFR
162.408; Use: The National Provider
Identifier Application and Update Form
is used by health care providers to apply
for NPIs and furnish updates to the
information they supplied on their
initial applications. The form is also
used to deactivate their NPIs if
necessary. The original application form
was approved in February 2005 and has
been in use since May 23, 2005. The
form is available on paper or can be
completed via a web-based process.
Health care providers can mail a paper
application, complete the application
via the web-based process via the
National Plan and Provider
Enumeration System (NPPES), or have a
trusted organization submit the
application on their behalf via the
Electronic File Interchange (EFI)
process. The Enumerator uses the
NPPES to process the application and
generate the NPI. NPPES is the Medicare
contractor tasked with issuing NPIs, and
maintaining and storing NPI data. Form
Number: CMS–10114 (OMB control
number: 0938–0931); Frequency: On
occasion; Affected Public: Business or
other for-profit, Not-for-profit
institutions, and Federal government;
Number of Respondents: 1,473,185;
Total Annual Responses: 1,473,185;
Total Annual Hours: 250,442. (For
policy questions regarding this
collection contact Kimberly McPhillips
at 410–786–5374).
2. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: Hospice
Request for Certification and Supporting
Regulations; Use: The Hospice Request
for Certification Form is the
identification and screening form used
to initiate the certification process and
to determine if the provider has
sufficient personnel to participate in the
Medicare program. Form Number:
CMS–417 (OMB Control number: 0938–
0313); Frequency: Annually; Affected
Public: Private Sector—Business or
other for-profits; Number of
Respondents: 851; Total Annual
Responses: 851; Total Annual Hours:
213. (For policy questions regarding this
collection contact Thomas Pryor at 410–
786–1332.)
VerDate Sep<11>2014
17:29 Oct 25, 2017
Jkt 244001
Dated: October 23, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–23341 Filed 10–25–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1486]
Authorizations of Emergency Use of In
Vitro Diagnostic Devices for Detection
of Zika Virus; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of two Emergency Use
Authorizations (EUAs) (the
Authorizations) for in vitro diagnostic
devices for detection of the Zika virus
in response to the Zika virus outbreak
in the Americas. FDA issued these
Authorizations under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by Thermo Fisher
Scientific and The Center for Infection
and Immunity, Columbia University.
The Authorizations contain, among
other things, conditions on the
emergency use of the authorized in vitro
diagnostic devices. The Authorizations
follow the February 26, 2016,
determination by the Secretary of Health
and Human Services (HHS) that there is
a significant potential for a public
health emergency that has a significant
potential to affect national security or
the health and security of U.S. citizens
living abroad and that involves Zika
virus. On the basis of such
determination, the Secretary of HHS
declared on February 26, 2016, that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostic tests for detection of
Zika virus and/or diagnosis of Zika
virus infection, subject to the terms of
any authorization issued under the
FD&C Act. The Authorizations, which
include an explanation of the reasons
for issuance, are reprinted in this
document.
DATES: The Authorization for Thermo
Fisher Scientific is applicable as of
August 2, 2017; the Authorization for
The Center for Infection and Immunity,
Columbia University is effective as of
August 11, 2017.
ADDRESSES: Submit written requests for
single copies of the EUAs to the Office
SUMMARY:
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of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the Authorizations may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorizations.
FOR FURTHER INFORMATION CONTACT:
Carmen Maher, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4347, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces of
attack with a biological, chemical,
radiological, or nuclear agent or agents;
(3) a determination by the Secretary of
HHS that there is a public health
emergency, or a significant potential for
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]]>Agencies
[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49611-49612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23341]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10114 and CMS-417]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected; and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by November 27, 2017.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions: OMB,
Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395-5806 OR, Email:
OIRA_[email protected].
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at Web site address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes
[[Page 49612]]
the following proposed collection(s) of information for public comment:
1. Type of Information Collection Request: Extension of a currently
approved collection;
Title of Information Collection: National Provider Identifier (NPI)
Application and Update Form and Supporting Regulations in 45 CFR
142.408, 45 CFR 162.406, 45 CFR 162.408; Use: The National Provider
Identifier Application and Update Form is used by health care providers
to apply for NPIs and furnish updates to the information they supplied
on their initial applications. The form is also used to deactivate
their NPIs if necessary. The original application form was approved in
February 2005 and has been in use since May 23, 2005. The form is
available on paper or can be completed via a web-based process. Health
care providers can mail a paper application, complete the application
via the web-based process via the National Plan and Provider
Enumeration System (NPPES), or have a trusted organization submit the
application on their behalf via the Electronic File Interchange (EFI)
process. The Enumerator uses the NPPES to process the application and
generate the NPI. NPPES is the Medicare contractor tasked with issuing
NPIs, and maintaining and storing NPI data. Form Number: CMS-10114 (OMB
control number: 0938-0931); Frequency: On occasion; Affected Public:
Business or other for-profit, Not-for-profit institutions, and Federal
government; Number of Respondents: 1,473,185; Total Annual Responses:
1,473,185; Total Annual Hours: 250,442. (For policy questions regarding
this collection contact Kimberly McPhillips at 410-786-5374).
2. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Hospice Request for Certification and Supporting
Regulations; Use: The Hospice Request for Certification Form is the
identification and screening form used to initiate the certification
process and to determine if the provider has sufficient personnel to
participate in the Medicare program. Form Number: CMS-417 (OMB Control
number: 0938-0313); Frequency: Annually; Affected Public: Private
Sector--Business or other for-profits; Number of Respondents: 851;
Total Annual Responses: 851; Total Annual Hours: 213. (For policy
questions regarding this collection contact Thomas Pryor at 410-786-
1332.)
Dated: October 23, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2017-23341 Filed 10-25-17; 8:45 am]
BILLING CODE 4120-01-P
