Proposed Information Collection Activity; Comment Request, 29866-29867 [2017-13726]
Download as PDF
<![CDATA[
29866
Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices
under consideration. At the conclusion
of the day, the members will vote and
the Committee will make its
recommendation(s) to CMS.
III. Registration Instructions
CMS’ Coverage and Analysis Group is
coordinating meeting registration. While
there is no registration fee, individuals
must register to attend. You may register
online at https://www.cms.gov/apps/
events/upcomingevents.asp?str
OrderBy=1&type=3 or by phone by
contacting the person listed in the FOR
FURTHER INFORMATION CONTACT section of
this notice by the deadline listed in the
DATES section of this notice. Please
provide your full name (as it appears on
your state-issued driver’s license),
address, organization, telephone
number(s), fax number, and email
address. You will receive a registration
confirmation with instructions for your
arrival at the CMS complex or you will
be notified that the seating capacity has
been reached.
IV. Security, Building, and Parking
Guidelines
This meeting will be held in a federal
government building; therefore, federal
security measures are applicable. The
Real ID Act, enacted in 2005, establishes
minimum standards for the issuance of
state-issued driver’s licenses and
identification (ID) cards. It prohibits
Federal agencies from accepting an
official driver’s license or ID card from
a state unless the Department of
Homeland Security determines that the
state meets these standards. Beginning
October 2015, photo IDs (such as a valid
driver’s license) issued by a state or
territory not in compliance with the
Real ID Act will not be accepted as
identification to enter Federal buildings.
Visitors from these states/territories will
need to provide alternative proof of
identification (such as a valid passport)
to gain entrance into CMS buildings.
The current list of states from which a
Federal agency may accept driver’s
licenses for an official purpose is found
at https://www.dhs.gov/real-idenforcement-brief. We recommend that
confirmed registrants arrive reasonably
early, but no earlier than 45 minutes
prior to the start of the meeting, to allow
additional time to clear security.
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel.
• Inspection of vehicle’s interior and
exterior (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Inspection, via metal detector or
other applicable means, of all persons
entering the building. We note that all
items brought into CMS, whether
personal or for the purpose of
presentation or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for
presentation or to support a
presentation.
Note: Individuals who are not
registered in advance will not be
permitted to enter the building and will
be unable to attend the meeting. The
public may not enter the building earlier
than 45 minutes prior to the convening
of the meeting.
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building.
V. Collection of Information
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
Authority: 5 U.S.C. App. 2, section 10(a).
Dated: June 22, 2017.
Kate Goodrich,
Director, Center for Clinical Standards and
Quality, Centers for Medicare & Medicaid
Services.
[FR Doc. 2017–13785 Filed 6–29–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No.: 0970–0422]
Proposed Information Collection
Activity; Comment Request
Title: Adoption and Foster Care
Analysis Reporting System for title IV–
B and title IV–E (AFCARS).
Description: The Adoption and Foster
Care Analysis and Reporting System
(AFCARS) is mandated by 42 U.S.C.
679. The regulation at 45 CFR 1355 sets
forth the requirements of section 479 of
the Social Security Act for the collection
of uniform, reliable information on
children who are under the
responsibility of the State or Tribal title
IV–B/IV–E agency for placement, care,
and adoption. Effective October 1, 2009,
section 479B(b) of the Act authorizes
direct Federal funding of Indian Tribes,
Tribal organizations, and Tribal
consortia that choose to operate a foster
care, adoption assistance and, at Tribal
option, a kinship guardianship
assistance program under title IV–E of
the Act. The data collected per the
requirements at 45 CFR 1355.40 will
end September 30, 2019. On October 1,
2019 the data collection will be replaced
by the requirements in 45 CFR
1355.41—44, as reflected in the final
rule published in the Federal Register
on December 14, 2016 (81 FR 90524).
The data collected will inform State/
Tribal/Federal policy decisions,
program management, and responses to
Congressional and Departmental
inquiries. Specifically, the data are used
for short/long-term budget projections,
trend analysis, child and family service
reviews, and to target areas for
improved technical assistance. The data
will provide information about foster
care placements, adoptive parents,
length of time in care, delays in
termination of parental rights and
placement for adoption.
Respondents: Title IV–E State and
Tribal Child Welfare Agencies.
mstockstill on DSK30JT082PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
AFCARS ..........................................................................................................
VerDate Sep<11>2014
17:32 Jun 29, 2017
Jkt 241001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
59
E:\FR\FM\30JNN1.SGM
2
30JNN1
Average
burden hours
per response
2,188
Total burden
hours
258,215
Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices
Estimated Total Annual Burden
Hours: 258,215.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–13726 Filed 6–29–17; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3224]
Authorization of Emergency Use of an
Injectable Treatment for Nerve Agent
or Certain Insecticide
(Organophosphorus and/or
Carbamate) Poisoning; Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK30JT082PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for an injectable treatment for nerve
agent or certain insecticide
(organophosphorus and/or carbamate)
SUMMARY:
VerDate Sep<11>2014
17:32 Jun 29, 2017
Jkt 241001
poisoning. FDA issued this
Authorization under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by the U.S. Centers for
Disease Control and Prevention (CDC).
The Authorization contains, among
other things, conditions on the
emergency use of the authorized
injectable treatment. The Authorization
follows the April 11, 2017,
determination by the Department of
Health and Human Services (HHS)
Secretary 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 nerve agents or certain
insecticides (organophosphorus and/or
carbamate). On the basis of such
determination, the HHS Secretary
declared on April 11, 2017, that
circumstances exist justifying the
authorization of emergency use of
injectable treatments for nerve agent or
certain insecticide (organophosphorus
and/or carbamate) poisoning, subject to
the terms of any authorization issued
under the FD&C Act. The Authorization,
which includes an explanation of the
reasons for issuance, is reprinted in this
document.
DATES: The Authorization is effective as
of April 11, 2017.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
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 Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
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.
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
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
29867
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
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of U.S. citizens living abroad,
and that involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
under section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
E:\FR\FM\30JNN1.SGM
30JNN1
]]>Agencies
[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Pages 29866-29867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13726]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB No.: 0970-0422]
Proposed Information Collection Activity; Comment Request
Title: Adoption and Foster Care Analysis Reporting System for title
IV-B and title IV-E (AFCARS).
Description: The Adoption and Foster Care Analysis and Reporting
System (AFCARS) is mandated by 42 U.S.C. 679. The regulation at 45 CFR
1355 sets forth the requirements of section 479 of the Social Security
Act for the collection of uniform, reliable information on children who
are under the responsibility of the State or Tribal title IV-B/IV-E
agency for placement, care, and adoption. Effective October 1, 2009,
section 479B(b) of the Act authorizes direct Federal funding of Indian
Tribes, Tribal organizations, and Tribal consortia that choose to
operate a foster care, adoption assistance and, at Tribal option, a
kinship guardianship assistance program under title IV-E of the Act.
The data collected per the requirements at 45 CFR 1355.40 will end
September 30, 2019. On October 1, 2019 the data collection will be
replaced by the requirements in 45 CFR 1355.41--44, as reflected in the
final rule published in the Federal Register on December 14, 2016 (81
FR 90524).
The data collected will inform State/Tribal/Federal policy
decisions, program management, and responses to Congressional and
Departmental inquiries. Specifically, the data are used for short/long-
term budget projections, trend analysis, child and family service
reviews, and to target areas for improved technical assistance. The
data will provide information about foster care placements, adoptive
parents, length of time in care, delays in termination of parental
rights and placement for adoption.
Respondents: Title IV-E State and Tribal Child Welfare Agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
AFCARS.......................................... 59 2 2,188 258,215
----------------------------------------------------------------------------------------------------------------
[[Page 29867]]
Estimated Total Annual Burden Hours: 258,215.
In compliance with the requirements of the Paperwork Reduction Act
of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for
Children and Families is soliciting public comment on the specific
aspects of the information collection described above. Copies of the
proposed collection of information can be obtained and comments may be
forwarded by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 330 C Street SW.,
Washington DC 20201. Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017-13726 Filed 6-29-17; 8:45 am]
BILLING CODE 4184-01-P
