83 FR 32875 - Proposed Information Collection Activity; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 83, Issue 136 (July 16, 2018)
Administration for Children and Families
Federal Register Volume 83, Issue 136 (July 16, 2018)
| Page Range | 32875-32877 | |
| FR Document | 2018-15149 |
[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)] [Notices] [Pages 32875-32877] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15149] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: U.S. Repatriation Program Forms. OMB No.: 0970--NEW (two of the forms have prior OMB No: [SSA-3955 & SSA-2061]) 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 Refugee Resettlement. 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 in order to provide assistance to U.S. citizens and others evacuated from overseas areas. Overall, the Program manages two major activities, Emergency and Non-emergency Repatriation Activities. The ongoing routine arrivals of individual repatriates and the repatriation of individuals with mental illness constitute the Program Non-emergency activities. Emergency activities are comprised of group repatriations (evacuations of 50-500 individuals) and emergency repatriations (evacuations of 500 or more individuals). Operationally, these activities involve different kinds of preparation, resources, and implementation. However, the core Program policies and administrative procedures are essentially the same. The Program provides services through agreements with local repatriation service providers (e.g. States, federal agencies, non- governmental agencies, etc.). For the purpose of this Program, local repatriation service provider (local provider) has the same definition of ``agency'' as defined under 45 CFR 212.1 (i). 1. The HHS Repatriation Program Emergency and Group Processing Form: Under 45 CFR 211 and 212, ORR is to make findings setting forth the pertinent facts and conclusions according to established standards to determine whether an individual is an eligible person. This form allows authorized staff to gather necessary information to determine eligibility and needed services. This form is to be utilized during emergencies and group repatriations. Individuals interested in receiving Repatriation assistance will complete appropriate portions of this form. State personnel will utilize this form as a guide to perform an initial eligibility and needs assessment. An authorized federal staff from the ACF will make final eligibility determinations through the approval of this form. 2. The U.S. Repatriation Program Privacy and Repayment Agreement [[Page 32876]] Form: Under 45 CFR 211 and 212, individuals who receive Program assistance are required to repay the federal government for the cost associated to the services received. This form authorizes ORR to release personal identifiable information to partners for the purpose of providing services to eligible repatriates. In addition, through this form, eligible repatriates agree to accept services under the terms and conditions of the Program. Specifically, eligible repatriates commit to repay the federal government for all services received while in the Program. This form is to be completed by eligible repatriates or authorized legal custodian. Exception applies to unaccompanied minors and individuals eligible under 45 CFR 211, if no legal custodian is identified. 3. Relinquish Repatriation Services Form: For individuals who are eligible to receive repatriation assistance but opt to relinquish services, this form is utilized to confirm and record repatriate's decision to refuse Program assistance. This form is to be completed by eligible repatriates or authorized legal custodian. Exception applies to unaccompanied minors and individuals eligible under 45 CFR 211, if no legal custodian is identified. 4. The U.S. Repatriation Program Emergency Financial Form: Under Section 1113 of the Social Security Act, ORR is authorized to provide temporary assistance directly or through utilization of the services and facilities of appropriate public or private agencies and organizations, in accordance with agreements providing for payment, as may be determined by ORR. This form is to be utilized and completed by ORR local providers to request reimbursement of reasonable and allowable costs, both administrative and actual temporary services, after emergency activities. 5. The U.S. Repatriation Program Non-emergency Reimbursement Form: Under Section 1113 of the Social Security Act, ORR is authorized to provide temporary assistance directly or through arrangements, in accordance with agreements providing for payment, as may be determined by ORR. This form is to be utilized and completed by ORR local providers to request reimbursement of reasonable and allowable costs, both administrative and actual temporary services. 6. The U.S. Repatriation Program Financial Waiver Request Form: In accordance with 45 CFR 211 & 212 individuals who have received Repatriation assistance may be eligible to receive a waiver or deferral of their repatriation loan. This form is to be completed by eligible repatriates, authorized legal custodian, or the repatriation local provider. Exception applies to unaccompanied minors and individuals eligible under 45 CFR 211, if no legal custodian is identified. 7. The U.S. Repatriation Program Temporary Assistance Extension Request Form: Under 45 CFR 211 & 212 temporary assistance may be furnished beyond the 90 days eligibility period. This form is to be completed by the eligible repatriates, authorized legal custodian, or the repatriation local provider. This form should be submitted to ORR or its authorized grantee 14 days prior to the expiration of the 90 days eligibility period. 8. The U.S. Repatriation Program Individual Case Management Report and Financial Claim Form: Under Section 1113 of the Social Security Act, ORR is authorized to provide temporary assistance directly or through agreements with public and private agencies. This form is to be utilized and completed by ORR local provider to request reimbursement of reasonable and allowable costs, both administrative and actual temporary services. This form should also be utilized by the local repatriation provider for submit case updates. This forms is to be completed by authorized local providers. Respondents: Repatriation Program local repatriation service provider and individuals repatriated or evacuated by DOS from overseas. These respondents are authorized under Title XI, Section 1113 of the Social Security Act (42 U.S.C. 1313), Executive Order 12656 (amended by E.O. 13074, February 9, 1998; E.O. 13228, October 8, 2001; E.O. 13286, February 28, 2003), and 45 CFR 211 & 212. Annual Burden Estimates ---------------------------------------------------------------------------------------------------------------- Average burden Instrument Number of respondents Number of responses hours per Total burden hours per respondent response ---------------------------------------------------------------------------------------------------------------- U.S. Repatriation Program 500 or more.......... 1................... 0.15 75 or more. Emergency and Group Processing Form. U.S. Repatriation Program 1000 or more......... 1................... 0.05 50 or more. Privacy and Repayment Agreement Form:. U.S. Repatriation Program 50 or more........... 1................... 0.05 0.8 or more. Relinquish Temporary Assistance Form. U.S. Repatriation Program 4 or more............ 1................... .20 4 or more. Emergency and Group Financial Form. U.S. Repatriation Program Non- 53 or more........... 1................... 0.20 10.6 or more. emergency Monthly Financial Statement Form. U.S. Repatriation Program 100 or more.......... 1................... 1 100 or more. Loan Waiver Request Form. U.S. Repatriation Program 500 or more.......... 1................... 0.20 100 or more. Temporary Assistance Extension Request Form. U.S. Repatriation Program 1000 or more......... 1 or more........... 0.20 200 or more. Individual Case Management Report. ---------------------------------------------------------------------------------------------------------------- Estimated Total Annual Burden Hours: 540.4. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, 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, 370 L'Enfant Promenade SW, Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: [email protected]. 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 information to be collected; and (d) ways to minimize the burden of the collection of information on [[Page 32877]] 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. 2018-15149 Filed 7-13-18; 8:45 am] BILLING CODE 4184-01-P
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must obtain approval from the Office of access health equity resources. Form U.S.C. Sections 321 through 329).
Management and Budget (OMB) for each Number: CMS–10669 (OMB control Further refinements occurred in
collection of information they conduct number: 0938—New); Frequency: response to Executive Order (E.O.)
or sponsor. The term ‘‘collection of Occasionally; Affected Public: Private 11490 (as amended) where HHS was
information’’ is defined in 44 U.S.C. sector (Business or other For-profits); given the responsibility to ‘‘develop
3502(3) and 5 CFR 1320.3(c) and Number of Respondents: 274; Total plans and procedures for assistance at
includes agency requests or Annual Responses 274; Total Annual ports of entry to U.S. personnel
requirements that members of the public Hours: 23. (For policy questions evacuated from overseas areas, their
submit reports, keep records, or provide regarding this collection contact onward movement to final destination,
information to a third party. Section Alexandra Bryden at 410–786–2076). and follow-up assistance after arrival at
3506(c)(2)(A) of the PRA (44 U.S.C. Dated: July 11, 2018. final destination.’’ In addition, under
3506(c)(2)(A)) requires federal agencies William N. Parham, III, E.O. 12656 (53 CFR 47491),
to publish a 30-day notice in the ‘‘Assignment of emergency
Director, Paperwork Reduction Staff, Office
Federal Register concerning each of Strategic Operations and Regulatory preparedness responsibilities,’’ HHS
proposed collection of information, Affairs. was given the lead responsibility to
including each proposed extension or [FR Doc. 2018–15146 Filed 7–13–18; 8:45 am]
develop plans and procedures in order
reinstatement of an existing collection to provide assistance to U.S. citizens
BILLING CODE 4120–01–P
of information, before submitting the and others evacuated from overseas
collection to OMB for approval. To areas.
comply with this requirement, CMS is DEPARTMENT OF HEALTH AND Overall, the Program manages two
publishing this notice that summarizes HUMAN SERVICES major activities, Emergency and Non-
the following proposed collection(s) of emergency Repatriation Activities. The
information for public comment: Administration for Children and ongoing routine arrivals of individual
1. Type of Information Collection Families repatriates and the repatriation of
Request: New collection (Request for a individuals with mental illness
new OMB control number); Title of Proposed Information Collection constitute the Program Non-emergency
Information Collection: Health Equity Activity; Comment Request activities. Emergency activities are
Technical Assistance Monitoring and comprised of group repatriations
Tracking; Use: The Centers for Medicare Proposed Projects (evacuations of 50–500 individuals) and
& Medicaid Services (CMS) Office of Title: U.S. Repatriation Program emergency repatriations (evacuations of
Minority Health (OMH) developed the Forms. 500 or more individuals). Operationally,
CMS Equity Plan for Improving Quality OMB No.: 0970—NEW (two of the these activities involve different kinds
in Medicare (CMS Equity Plan for forms have prior OMB No: [SSA–3955 & of preparation, resources, and
Medicare). The Plan outlines CMS’ path SSA–2061]) implementation. However, the core
to help advance health equity by Description: The United States (U.S.) Program policies and administrative
improving the quality of care provided Repatriation Program was established by procedures are essentially the same. The
to minority and other underserved Title XI, Section 1113 of the Social Program provides services through
Medicare beneficiaries, particularly Security Act (Assistance for U.S. agreements with local repatriation
those with disparities in chronic Citizens Returned from Foreign service providers (e.g. States, federal
diseases. CMS identified six high- Countries) to provide temporary agencies, non-governmental agencies,
impact priority areas based on a review assistance to U.S. citizens and their etc.). For the purpose of this Program,
of the evidence base and stakeholder dependents who have been identified by local repatriation service provider (local
input. These priorities encompass both the Department of State (DOS) as having provider) has the same definition of
system- and community-level returned, or been brought from a foreign ‘‘agency’’ as defined under 45 CFR 212.1
approaches to achieve equity in country to the U.S. because of (i).
Medicare. Priority 2: Evaluate destitution, illness, war, threat of war, 1. The HHS Repatriation Program
Disparities Impacts and Integrate Equity or a similar crisis, and are without Emergency and Group Processing Form:
Solutions Across CMS Programs, available resources immediately Under 45 CFR 211 and 212, ORR is to
focuses on increasing understanding of accessible to meet their needs. The make findings setting forth the pertinent
the impact CMS programs have on Secretary of the Department of Health facts and conclusions according to
health disparities and on identifying, and Human Services (HHS) was established standards to determine
developing and integrating proven provided with the authority to whether an individual is an eligible
solutions to improve their impact on administer this Program. On or about person. This form allows authorized
vulnerable populations. 1994, this authority was delegated by staff to gather necessary information to
CMS created a Health Equity the HHS Secretary to the Administration determine eligibility and needed
Technical Assistance (TA) email for Children and Families (ACF) and services. This form is to be utilized
(HealthEquityTA@cms.hhs.gov) to later re-delegated by ACf to the Office of during emergencies and group
support CMS programs as they integrate Refugee Resettlement. The Repatriation repatriations. Individuals interested in
health equity into their programs. This Program works with States, Federal receiving Repatriation assistance will
TA offers guidance from health equity agencies, and non-governmental complete appropriate portions of this
subject matter experts on a variety of organizations to provide eligible form. State personnel will utilize this
sradovich on DSK3GMQ082PROD with NOTICES
topics including reviewing data to individuals with temporary assistance form as a guide to perform an initial
identify health disparities, identifying for up to 90-days. This assistance is in eligibility and needs assessment. An
root causes of health disparities, gaining the form of a loan and must be repaid authorized federal staff from the ACF
an organizational champion, building to the Federal Government. will make final eligibility
organizational capacity to address The Program was later expanded in determinations through the approval of
health disparities, implementing response to legislation enacted by this form.
interventions, tracking success of Congress to address the particular needs 2. The U.S. Repatriation Program
intervention, and serves as a portal to of persons with mental illness (24 Privacy and Repayment Agreement
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respondents, including through the use New Animal Drugs for Investigational (§ 511.1(b)(5)). We require sponsors
of automated collection techniques or Use upon request to submit information
other forms of information technology. with respect to the investigation to
OMB Control Number 0910–0117—
Consideration will be given to determine whether there are grounds for
Extension
comments and suggestions submitted terminating the exemption
within 60 days of this publication. FDA has the authority under the (§ 511.1(b)(6)). We require sponsors to
Federal Food, Drug, and Cosmetic Act report findings that may suggest
Robert Sargis, (FD&C Act) to approve new animal significant hazards pertinent to the
Reports Clearance Officer. drugs. A new animal drug application safety of the new animal drug
[FR Doc. 2018–15149 Filed 7–13–18; 8:45 am] (NADA) cannot be approved until, (§ 511.1(b)(8)(ii)). We also require
BILLING CODE 4184–01–P
among other things, the new animal reporting by importers of investigational
drug has been demonstrated to be safe new animal drugs for clinical
and effective for its intended use(s). In investigational use in animals
DEPARTMENT OF HEALTH AND order to properly test a new animal drug (§ 511.1(b)(9)). The information
HUMAN SERVICES for an intended use, appropriate provided by the sponsor in the NCIE is
scientific investigations must be needed to ensure that the proposed
Food and Drug Administration conducted. Under specific investigational use of the new animal
circumstances, section 512(j) of the drug is safe and that any edible food
FD&C Act (21 U.S.C. 360b(j)) permits will not be distributed without proper
[Docket No. FDA–2018–N–0341]
the use of an investigational new animal authorization from FDA. Information
Agency Information Collection drug to generate data to support an contained in an NCIE submission is
Activities; Submission for Office of NADA approval. Section 512(j) of the monitored under our Bio-Research
Management and Budget Review; FD&C Act authorizes us to issue Monitoring Program. This program
Comment Request; New Animal Drugs regulations relating to the permits us to monitor the validity of the
investigational use of new animal drugs. studies and to ensure the proper use of
for Investigational Use
Our regulations in 21 CFR part 511 set the drugs is maintained by the
forth the conditions for investigational investigators.
AGENCY: Food and Drug Administration,
use of new animal drugs and require Recordkeeping: If the new animal
HHS.
reporting and recordkeeping. The drug is only for tests in vitro or in
ACTION: Notice. information collected is necessary to laboratory research animals, the person
protect the public health. We use the distributing the new animal drug must
SUMMARY: The Food and Drug information to determine that maintain records showing the name and
Administration (FDA) is announcing investigational animal drugs are post office address of the expert or
that a proposed collection of distributed only to qualified expert organization to whom it is
information has been submitted to the investigators, adequate drug shipped and the date, quantity, and
Office of Management and Budget accountability records are maintained, batch or code mark of each shipment
(OMB) for review and clearance under and edible food products from treated and delivery for a period of 2 years after
the Paperwork Reduction Act of 1995. food-producing animals are safe for such shipment or delivery (§ 511.1(a)(3)
human consumption. We also use the and (b)(3)). We require complete records
DATES: Fax written comments on the information collected to monitor the of the investigation, including records of
collection of information by August 15, validity of the studies submitted to us the receipt and disposition of each
2018. to support new animal drug approval. shipment or delivery of the
Reporting: Our regulations require investigational new animal drug
ADDRESSES: To ensure that comments on
that certain information be submitted to (§ 511.1(b)(7)). We also require records
the information collection are received,
us in a ‘‘Notice of Claimed of all reports received by a sponsor from
OMB recommends that written
Investigational Exemption for a New investigators to be retained for 2 years
comments be faxed to the Office of
Animal Drug’’ (NCIE) to qualify for the after the termination of an
Information and Regulatory Affairs,
exemption and to control shipment of investigational exemption or approval of
OMB, Attn: FDA Desk Officer, Fax: 202– the new animal drug and prevent
395–7285, or emailed to oira_ a new animal drug application
potential abuse. The NCIE must contain, (§ 511.1(b)(8)(i)).
submission@omb.eop.gov. All among other things, the following
comments should be identified with the Description of Respondents:
specific information: (1) Identity of the Respondents to this collection of
OMB control number 0910–0117. Also new animal drug, (2) labeling, (3)
include the FDA docket number found information are persons who use new
statement of compliance of any animal drugs for investigational
in brackets in the heading of this nonclinical laboratory studies with good
document. purposes. Investigational new animal
laboratory practices, (4) name and drugs are used primarily by drug
FOR FURTHER INFORMATION CONTACT: address of each clinical investigator, (5) industry firms, academic institutions,
Amber Sanford, Office of Operations, the approximate number of animals to and the government. Investigators may
Food and Drug Administration, Three be treated or amount of new animal include individuals from these entities,
White Flint North, 10A–12M, 11601 drug(s) to be shipped, and (6) as well as research firms and members
Landsdown St., North Bethesda, MD information regarding the use of edible of the medical professions.
tissues from investigational animals
sradovich on DSK3GMQ082PROD with NOTICES
20852, 301–796–8867, PRAStaff@ In the Federal Register of February
fda.hhs.gov. (§ 511.1(b)(4) (21 CFR 511.1(b)(4)). If the 22, 2018 (83 FR 7735), FDA published
new animal drug is to be used in food- a 60-day notice requesting public
SUPPLEMENTARY INFORMATION: In producing animals, e.g., cattle, swine, comment on the proposed collection of
compliance with 44 U.S.C. 3507, FDA chickens, fish, etc., certain data must be information. No comments were
has submitted the following proposed submitted to us to obtain authorization received.
collection of information to OMB for for the use of edible food products from FDA estimates the burden of this
review and clearance. treated food-producing animals collection of information as follows:
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Document Created: 2018-07-14 00:53:26
Document Modified: 2018-07-14 00:53:26
| 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 | |
| FR Citation | 83 FR 32875 |
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