Submission for OMB Review; Comment Request, 11982-11983 [2019-06059]
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11982
Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices
under the authority of the Paperwork
Reduction Act (PRA) of 1995 (44 U.S.C.
Chapter 35).
VII. Executive Order 12866 Statement
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget.
Dated: March 15, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–06291 Filed 3–28–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
jbell on DSK30RV082PROD with NOTICES
Submission for OMB Review;
Comment Request
Title: U.S. Repatriation Program
Forms.
OMB No.: 0970–0474.
Description: The United States (U.S.)
Repatriation Program was established by
Title XI, Section 1113 of the Social
Security Act (Assistance for U.S.
Citizens Returned from Foreign
Countries) to provide temporary
assistance to U.S. citizens and their
dependents who have been identified by
the Department of State (DOS) as having
returned, or been brought from a foreign
country to the U.S. because of
destitution, illness, war, threat of war,
or a similar crisis, and are without
available resources immediately
accessible to meet their needs. The
Secretary of the Department of Health
and Human Services (HHS) was
provided with the authority to
administer this Program. On or about
1994, this authority was delegated by
the HHS Secretary to the Administration
for Children and Families (ACF) and
later re-delegated by ACF to the Office
of Human Services Emergency
Preparedness and Response (OHSEPR).
The Repatriation Program works with
States, Federal agencies, and nongovernmental organizations to provide
eligible individuals with temporary
assistance for up to 90 days. This
assistance is in the form of a loan and
must be repaid to the Federal
Government.
The Program was later expanded in
response to legislation enacted by
Congress to address the particular needs
of persons with mental illness (24
VerDate Sep<11>2014
17:48 Mar 28, 2019
Jkt 247001
U.S.C. Sections 321 through 329).
Further refinements occurred in
response to Executive Order (E.O.)
11490 (as amended) where HHS was
given the responsibility to ‘‘develop
plans and procedures for assistance at
ports of entry to U.S. personnel
evacuated from overseas areas, their
onward movement to final destination,
and follow-up assistance after arrival at
final destination.’’ In addition, under
E.O. 12656 (53 CFR 47491),
‘‘Assignment of emergency
preparedness responsibilities,’’ HHS
was given the lead responsibility to
develop plans and procedures to
provide assistance to U.S. citizens and
others evacuated from overseas.
In order to effectively and efficiently
manage these legislative authorities, the
Program has been divided into two
major activities, Emergency and NonEmergency Repatriation. Operationally,
these two Program activities involve
different kinds of preparation,
resources, and implementation.
However, the core Program statute,
regulations, policies, and administrative
procedures for these two Programs are
essentially the same. The ongoing
routine arrivals of individual repatriates
and the repatriation of individuals with
mental illness constitute the Program
Non-emergency activities. Emergency
Activities are characterized by
contingency events such as civil unrest,
war, threat of war or similar crisis,
among other incidents. Depending on
the type of event, number of evacuees
and resources available, ACF will
provide assistance using two scalable
mechanisms, emergency repatriations or
group repatriations. Emergency
repatriations assume the evacuation of
500 or more individuals, while group
repatriations assume the evacuation of
50–500 individuals.
The Program provides services
through agreements with the States, U.S.
Territories, Federal agencies, and nongovernmental agencies. The list of
Repatriation Forms is as follows:
1. Emergency and Group Processing
Form (RR–01): During an emergency
repatriation, individuals complete
portions of this form to apply for
repatriation assistance. Then State
personnel use the form to perform a
preliminary eligibility assessment.
Authorized ACF staff make final
eligibility decisions.
2. Emergency and Group Repatriation
Financial Form (RR–02): States and
supporting agencies complete this form
if they have entered into an agreement
PO 00000
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Fmt 4703
Sfmt 4703
with OHSEPR allowing for
reimbursement of reasonable and
allowable costs during emergency
repatriation activities.
3. Repatriation Loan Waiver and
Deferral Request Form (RR–03): Eligible
repatriates, authorized legal custodians,
or authorized state staff complete this
form to request a waiver or deferral of
a repatriation loan.
4. Non-Emergency Monthly Financial
Statement Form (RR–04): States and
other authorized OHSEPR agencies use
this form to request reimbursement of
reasonable and allowable costs for the
provision of temporary assistance
during non-emergency activities.
5. Privacy and Repayment Agreement
Form (RR–05): This form authorizes
HHS to release personally identifiable
information to appropriate agencies for
the purpose of providing services. In
addition, through this form, eligible
repatriates or authorized legal
custodians agree to accept services
under the Program’s terms and
conditions, which include repaying the
federal government for services
received.
6. Refusal of Temporary Assistance
Form (RR–06): Eligible repatriates or
authorized legal custodians use this
form to confirm and record their
decision to relinquish repatriation
services.
7. Temporary Assistance and
Extension Request Form (RR–07): To
request an extension of assistance
beyond the 90-day eligibility period,
eligible repatriates, authorized legal
custodians, or authorized state staff
submit this form to OHSEPR or its
designated grantee generally 14 days
prior to the expiration of the repatriate’s
eligibility period.
8. Emergency and Group Repatriation
State Request for Federal Support Form
(RR–08): During emergency repatriation
activities, OHSEPR-activated states must
use this form to request support and/or
assistance from the federal government,
including but not limited to
augmentation of personnel, funding,
and reimbursement.
Respondents: Designated state,
federal, and/or non-governmental
agencies and individuals and eligible
repatriates. Responders are authorized
by 42 U.S.C. 1313 and 24 U.S.C. 321–
329; Executive Order 12656 (as
amended by E.O. 13074, February 9,
1998; E.O. 13228, October 8, 2001; E.O.
13286, February 28, 2003); and
regulations found under 45 CFR 211 &
212.
E:\FR\FM\29MRN1.SGM
29MRN1
11983
Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Form
Emergency and Group Processing Form ........................................................
Privacy and Repayment Agreement Form ......................................................
Refusal of Temporary Assistance Form ..........................................................
Emergency and Group Repatriation Financial Form .......................................
Non-Emergency Monthly Financial Statement Form .......................................
Repatriation Loan Waiver and Deferral Request Form ...................................
Emergency and Group Repatriation State Request for Federal Support
Form .............................................................................................................
Temporary Assistance and Extension Request Form .....................................
Average
burden
hours per
response
Frequency
of the
response
Total
annual burden
hours
25,000
25,000
15
15
52
800
1
1
1
1
12
1
0.30
0.05
0.05
0.30
0.30
0.30
7,500
1,250
0.75
4.5
187
240
20
50
1
1
0.30
0.30
6
15
Estimated Total Annual Burden Hours: 9203.25.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C St. SW, Washington, DC 20201, Attn:
ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–06059 Filed 3–28–19; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–0914]
jbell on DSK30RV082PROD with NOTICES
Review and Update of Device
Establishment Inspection Processes
and Standards; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
SUMMARY:
VerDate Sep<11>2014
17:48 Mar 28, 2019
Jkt 247001
guidance entitled ‘‘Review and Update
of Device Establishment Inspection
Processes and Standards.’’ FDA is
issuing this draft guidance document to
comply with changes to the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) as amended by the FDA
Reauthorization Act of 2017 (FDARA),
which requires that FDA review and
update, as needed, the processes and
standards applicable to inspections
(other than for-cause) of domestic and
foreign medical device establishments
in place as of August 18, 2017. This
draft guidance describes how FDA will
implement uniform inspection
processes and standards. The draft
guidance also describes standardized
methods of communication during the
inspection process and identifies
practices for investigators and device
establishments to facilitate the
continuity of inspections of such
establishments. This draft guidance is
not final nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by May 28, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
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Frm 00058
Fmt 4703
Sfmt 4703
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–0914 for ‘‘Review and Update
of Device Establishment Inspection
Processes and Standards.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11982-11983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: U.S. Repatriation Program Forms.
OMB No.: 0970-0474.
Description: The United States (U.S.) Repatriation Program was
established by Title XI, Section 1113 of the Social Security Act
(Assistance for U.S. Citizens Returned from Foreign Countries) to
provide temporary assistance to U.S. citizens and their dependents who
have been identified by the Department of State (DOS) as having
returned, or been brought from a foreign country to the U.S. because of
destitution, illness, war, threat of war, or a similar crisis, and are
without available resources immediately accessible to meet their needs.
The Secretary of the Department of Health and Human Services (HHS) was
provided with the authority to administer this Program. On or about
1994, this authority was delegated by the HHS Secretary to the
Administration for Children and Families (ACF) and later re-delegated
by ACF to the Office of Human Services Emergency Preparedness and
Response (OHSEPR). The Repatriation Program works with States, Federal
agencies, and non-governmental organizations to provide eligible
individuals with temporary assistance for up to 90 days. This
assistance is in the form of a loan and must be repaid to the Federal
Government.
The Program was later expanded in response to legislation enacted
by Congress to address the particular needs of persons with mental
illness (24 U.S.C. Sections 321 through 329). Further refinements
occurred in response to Executive Order (E.O.) 11490 (as amended) where
HHS was given the responsibility to ``develop plans and procedures for
assistance at ports of entry to U.S. personnel evacuated from overseas
areas, their onward movement to final destination, and follow-up
assistance after arrival at final destination.'' In addition, under
E.O. 12656 (53 CFR 47491), ``Assignment of emergency preparedness
responsibilities,'' HHS was given the lead responsibility to develop
plans and procedures to provide assistance to U.S. citizens and others
evacuated from overseas.
In order to effectively and efficiently manage these legislative
authorities, the Program has been divided into two major activities,
Emergency and Non-Emergency Repatriation. Operationally, these two
Program activities involve different kinds of preparation, resources,
and implementation. However, the core Program statute, regulations,
policies, and administrative procedures for these two Programs are
essentially the same. The ongoing routine arrivals of individual
repatriates and the repatriation of individuals with mental illness
constitute the Program Non-emergency activities. Emergency Activities
are characterized by contingency events such as civil unrest, war,
threat of war or similar crisis, among other incidents. Depending on
the type of event, number of evacuees and resources available, ACF will
provide assistance using two scalable mechanisms, emergency
repatriations or group repatriations. Emergency repatriations assume
the evacuation of 500 or more individuals, while group repatriations
assume the evacuation of 50-500 individuals.
The Program provides services through agreements with the States,
U.S. Territories, Federal agencies, and non-governmental agencies. The
list of Repatriation Forms is as follows:
1. Emergency and Group Processing Form (RR-01): During an emergency
repatriation, individuals complete portions of this form to apply for
repatriation assistance. Then State personnel use the form to perform a
preliminary eligibility assessment. Authorized ACF staff make final
eligibility decisions.
2. Emergency and Group Repatriation Financial Form (RR-02): States
and supporting agencies complete this form if they have entered into an
agreement with OHSEPR allowing for reimbursement of reasonable and
allowable costs during emergency repatriation activities.
3. Repatriation Loan Waiver and Deferral Request Form (RR-03):
Eligible repatriates, authorized legal custodians, or authorized state
staff complete this form to request a waiver or deferral of a
repatriation loan.
4. Non-Emergency Monthly Financial Statement Form (RR-04): States
and other authorized OHSEPR agencies use this form to request
reimbursement of reasonable and allowable costs for the provision of
temporary assistance during non-emergency activities.
5. Privacy and Repayment Agreement Form (RR-05): This form
authorizes HHS to release personally identifiable information to
appropriate agencies for the purpose of providing services. In
addition, through this form, eligible repatriates or authorized legal
custodians agree to accept services under the Program's terms and
conditions, which include repaying the federal government for services
received.
6. Refusal of Temporary Assistance Form (RR-06): Eligible
repatriates or authorized legal custodians use this form to confirm and
record their decision to relinquish repatriation services.
7. Temporary Assistance and Extension Request Form (RR-07): To
request an extension of assistance beyond the 90-day eligibility
period, eligible repatriates, authorized legal custodians, or
authorized state staff submit this form to OHSEPR or its designated
grantee generally 14 days prior to the expiration of the repatriate's
eligibility period.
8. Emergency and Group Repatriation State Request for Federal
Support Form (RR-08): During emergency repatriation activities, OHSEPR-
activated states must use this form to request support and/or
assistance from the federal government, including but not limited to
augmentation of personnel, funding, and reimbursement.
Respondents: Designated state, federal, and/or non-governmental
agencies and individuals and eligible repatriates. Responders are
authorized by 42 U.S.C. 1313 and 24 U.S.C. 321-329; Executive Order
12656 (as amended by E.O. 13074, February 9, 1998; E.O. 13228, October
8, 2001; E.O. 13286, February 28, 2003); and regulations found under 45
CFR 211 & 212.
[[Page 11983]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Average burden
Form Number of Frequency of hours per Total annual
respondents the response response burden hours
----------------------------------------------------------------------------------------------------------------
Emergency and Group Processing Form............. 25,000 1 0.30 7,500
Privacy and Repayment Agreement Form............ 25,000 1 0.05 1,250
Refusal of Temporary Assistance Form............ 15 1 0.05 0.75
Emergency and Group Repatriation Financial Form. 15 1 0.30 4.5
Non-Emergency Monthly Financial Statement Form.. 52 12 0.30 187
Repatriation Loan Waiver and Deferral Request 800 1 0.30 240
Form...........................................
Emergency and Group Repatriation State Request 20 1 0.30 6
for Federal Support Form.......................
Temporary Assistance and Extension Request Form. 50 1 0.30 15
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 9203.25.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 330 C St. SW, Washington,
DC 20201, Attn: ACF Reports Clearance Officer. All requests should be
identified by the title of the information collection. Email address:
[email protected].
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Email:
[email protected].
Attn: Desk Officer for the Administration for Children and
Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-06059 Filed 3-28-19; 8:45 am]
BILLING CODE 4184-01-P
