83 FR 42895 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 83, Issue 165 (August 24, 2018)

Page Range		42895-42896
FR Document		2018-18351

Federal Register, Volume 83 Issue 165 (Friday, August 24, 2018)

[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42895-42896]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18351]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Sponsorship Review Procedures for Approval for Unaccompanied 
Alien Children.
    OMB No.: 0970-0278.
    Description: The Administration for Children (ACF), Office of 
Refugee Resettlement (ORR) requests the use of emergency processing 
procedures in accordance with 5 CFR Section 1320.13 to expand the scope 
of an existing information collection under OMB control number 0970-
0278, Reunification Procedures for Unaccompanied Alien Children, 
renamed to Sponsorship Review Procedures for Approval of Unaccompanied 
Alien Children. The information collection will allow ACF to conduct 
suitability assessments to vet potential sponsors of unaccompanied 
alien children in accordance with a Memorandum of Agreement (MOA) 
between ORR and the Department of Homeland Security. Specifically, the 
information collection allows ORR to obtain biometric and biographical 
information from sponsors, adult members of their household, and adult 
care givers identified in a sponsor care plan, where applicable. ORR in 
turn shares the information collected with other federal departments to 
conduct background checks. ORR intends the instruments used in this 
submission to be available for use by mid-May 2018.
    ACF cannot reasonably comply with the normal clearance procedures 
because the use of normal clearance procedures is reasonably likely to 
prevent the collection of needed information in a timely manner. 
Complying with the normal clearance procedures would delay or disrupt 
ORR's ability to expand the background checks in order to more 
comprehensively evaluate the suitability of potential sponsors of 
unaccompanied alien children, and to ensure safe and appropriate 
placement of children. The information collection is essential to the 
mission of the agency.
    Respondents: Sponsors, adult household members, parents or legal 
guardians of unaccompanied alien children.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Family Reunification Application................          50,000               1            0.75          37,500
Authorization for Release of Information........          90,000               1             0.5          45,000
Fingerprint Instructions........................          90,000               1            1.25         112,500

[[Page 42896]]

 
Letter of Designation...........................          25,000               1             0.5          12,500
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden per Respondent: 207,500.
    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 Street SW, 
Washington, DC 20201. Attention 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.

Robert A. Sargis,
Reports Clearance Officer.
[FR Doc. 2018-18351 Filed 8-23-18; 8:45 am]
 BILLING CODE 4184-01-P

42896 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices

ANNUAL BURDEN ESTIMATES—Continued
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Letter of Designation ....................................................................................... 25,000 1 0.5 12,500

Estimated Total Annual Burden per populations and whether there is ‘‘no drugs, including biologics, for
Respondent: 207,500. significant market’’ for drugs that prevention and treatment of certain
Additional Information: Copies of the prevent or treat PCP in developed diseases that, in the aggregate, affect
proposed collection may be obtained by countries. The Agency has determined millions of people throughout the
writing to the Administration for that PCP does not meet the statutory world. Further information about the
Children and Families, Office of criteria for designation as a tropical tropical disease PRV program can be
Planning, Research and Evaluation, 330 disease and declines to designate it as found in guidance for industry
C Street SW, Washington, DC 20201. such. ‘‘Tropical Disease Priority Review
Attention Reports Clearance Officer. All DATES: August 24, 2018. Vouchers’’ (81 FR 69537, October 6,
requests should be identified by the title ADDRESSES: Submit electronic 2016, available at https://
of the information collection. Email comments on additional diseases www.federalregister.gov/documents/
address: infocollection@acf.hhs.gov. suggested for designation to https:// 2015/08/20/2015-20554/designating-
OMB Comment: OMB is required to www.regulations.gov. Submit written additions-to-the-current-list-of-tropical-
make a decision concerning the comments on additional diseases diseases-in-the-federal-food-drug-and-
collection of information between 30 suggested for designation to the Dockets cosmetic). Additions to the statutory list
and 60 days after publication of this Management Staff (HFA–305), Food and of tropical diseases published in the
document in the Federal Register. Drug Administration, 5630 Fishers Federal Register can be accessed at
Therefore, a comment is best assured of Lane, Rm. 1061, Rockville, MD 20852. https://www.fda.gov/AboutFDA/Centers
having its full effect if OMB receives it All comments should be identified with Offices/OfficeofMedicalProducts
within 30 days of publication. Written the docket number found in brackets in andTobacco/CDER/ucm534162.htm.
comments and recommendations for the the heading of this document. In August 2015, FDA published a
proposed information collection should final order (80 FR 50559, August 20,
FOR FURTHER INFORMATION CONTACT:
be sent directly to the following: Office 2015) (final order) designating Chagas
Katherine Schumann, Center for Drug
of Management and Budget, Paperwork disease and neurocysticercosis as
Evaluation and Research, Food and
Reduction Project, Email: OIRA_ tropical diseases. That final order also
Drug Administration, 10903 New
SUBMISSION@OMB.EOP.GOV, Attn: sets forth FDA’s interpretation of the
Hampshire Ave., Bldg. 22, Rm. 6242,
Desk Officer for the Administration for statutory criteria for tropical disease
Silver Spring, MD 20993–0002, 301–
Children and Families. designation and expands the list of
796–1300, Katherine.Schumann@
Robert A. Sargis, fda.hhs.gov; or Office of tropical diseases under section
Communication, Outreach and 524(a)(3)(R) of the FD&C Act, which
Reports Clearance Officer.
Development (OCOD), Center for authorizes the FDA to designate by
[FR Doc. 2018–18351 Filed 8–23–18; 8:45 am]
Biologics Evaluation and Research, order ‘‘[a]ny other infectious disease for
BILLING CODE 4184–01–P
Food and Drug Administration, 10903 which there is no significant market in
New Hampshire Ave., Silver Spring, MD developed nations and that
20993–0002, 800–835–4709 or 240– disproportionately affects poor and
DEPARTMENT OF HEALTH AND
402–8010, ocod@fda.hhs.gov. marginalized populations’’ as a tropical
HUMAN SERVICES
disease.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration FDA has applied its August 2015
Table of Contents criteria as set forth in the final order to
[Docket No. FDA–2008–N–0567] analyze whether PCP meets the
I. Background: Priority Review Voucher
Program statutory criteria for addition to the
Notice of Decision Not To Designate
II. Decision Not To Designate Pneumocystis tropical disease list. As discussed
Pneumocystis Pneumonia as a
Pneumonia below, the Agency has determined that
Tropical Disease A. Significant Market in Developed PCP does not meet the statutory criteria
AGENCY: Food and Drug Administration, Nations for designation as a ‘‘tropical disease’’
HHS. B. Disproportionately Affects Poor and and thus will not add it to the list of
Marginalized Populations tropical diseases whose applications
ACTION: Notice. C. FDA Determination
III. Process for Requesting Additional may be eligible for a priority review
SUMMARY: The Food and Drug Diseases To Be Added to the List voucher.
Administration (FDA or Agency), in IV. Paperwork Reduction Act
response to suggestions submitted to II. Decision Not To Designate
V. References
Docket No. FDA–2008–N–0567, has Pneumocystis Pneumonia
analyzed whether Pneumocystis I. Background: Priority Review FDA has considered all diseases
daltland on DSKBBV9HB2PROD with NOTICES

pneumonia (PCP) meets the statutory Voucher Program submitted to the public docket (FDA–
criteria for designation as a tropical Section 524 of the FD&C Act (21 2008–N–0567) between August 20,
disease for the purposes of obtaining a U.S.C. 360n), which was added by 2015, and June 20, 2018, as potential
priority review voucher (PRV) under the section 1102 of the Food and Drug additions to the list of tropical diseases
Federal Food, Drug, and Cosmetic Act Administration Amendments Act of under section 524 of the FD&C Act,
(FD&C Act), namely whether it 2007 (FDAAA), uses a PRV incentive to under the docket review process
primarily affects poor and marginalized encourage the development of new explained on the Agency’s website (see

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Document Created: 2018-08-24 04:14:21
Document Modified: 2018-08-24 04:14:21

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 42895

83 FR 42895 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 83, Issue 165 (August 24, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families