Submission for OMB Review; Comment Request, 42895-42896 [2018-18351]

Download as PDF 42895 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices ANNUAL BURDEN ESTIMATES Total number of respondents Instrument FACES 2019 Classroom sampling form from Head Start staff ................................................................................... FACES 2019 Child roster form from Head Start staff ......... FACES 2019 Parent consent form ...................................... FACES 2019 Head Start parent survey .............................. FACES 2019 Head Start child assessment ........................ FACES 2019 Head Start teacher child report ..................... FACES 2019 Head Start teacher survey ............................ FACES 2019 Head Start program director survey .............. FACES 2019 Head Start center director survey ................. AI/AN FACES 2019 Classroom sampling form from Head Start staff .......................................................................... AI/AN FACES 2019 Child roster form from Head Start staff ................................................................................... AI/AN FACES 2019 Parent consent form ........................... AI/AN FACES 2019 Head Start parent survey .................... AI/AN FACES 2019 Head Start child assessment .............. AI/AN FACES 2019 Head Start teacher child report .......... AI/AN FACES 2019 Head Start teacher survey .................. AI/AN FACES 2019 Head Start program director survey ... AI/AN FACES 2019 Head Start center director survey ....... Estimated Total Annual Burden Hours: 3,357. 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. (Authority: Section 640(a)(2)(D) and section 649 of the Improving Head Start for School Readiness Act of 2007) Emily B. Jabbour, ACF/OPRE Certifying Officer. [FR Doc. 2018–18333 Filed 8–23–18; 8:45 am] BILLING CODE 4184–22–P Annual number of respondents Number of responses per respondent Average burden hours per response Annual burden hours 360 120 2,400 2,400 2,400 240 720 180 360 120 40 800 800 800 80 240 60 120 1 1 1 2 2 20 1 1 1 0.17 0.33 0.17 0.42 0.75 0.17 0.50 0.50 0.50 20 13 136 672 1,200 272 120 30 60 37 13 1 0.17 2 37 800 800 800 80 80 22 37 13 267 267 267 27 27 8 13 1 1 2 2 20 1 1 1 0.33 0.17 0.50 0.75 0.17 0.58 0.33 0.33 4 45 267 401 92 16 3 4 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. daltland on DSKBBV9HB2PROD with NOTICES ANNUAL BURDEN ESTIMATES Number of respondents Instrument Family Reunification Application ...................................................................... Authorization for Release of Information ......................................................... Fingerprint Instructions .................................................................................... VerDate Sep<11>2014 19:17 Aug 23, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Number of responses per respondent 50,000 90,000 90,000 E:\FR\FM\24AUN1.SGM 1 1 1 24AUN1 Average burden hours per response 0.75 0.5 1.25 Total burden hours 37,500 45,000 112,500 42896 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices ANNUAL BURDEN ESTIMATES—Continued Number of respondents Instrument Letter of Designation ....................................................................................... 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: 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. Robert A. Sargis, Reports Clearance Officer. [FR Doc. 2018–18351 Filed 8–23–18; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Notice of Decision Not To Designate Pneumocystis Pneumonia as a Tropical Disease AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to Docket No. FDA–2008–N–0567, has analyzed whether Pneumocystis pneumonia (PCP) meets the statutory criteria for designation as a tropical disease for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:17 Aug 23, 2018 Jkt 244001 25,000 populations and whether there is ‘‘no significant market’’ for drugs that prevent or treat PCP in developed countries. The Agency has determined that PCP does not meet the statutory criteria for designation as a tropical disease and declines to designate it as such. DATES: August 24, 2018. ADDRESSES: Submit electronic comments on additional diseases suggested for designation to https:// www.regulations.gov. Submit written comments on additional diseases suggested for designation to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993–0002, 301– 796–1300, Katherine.Schumann@ fda.hhs.gov; or Office of Communication, Outreach and Development (OCOD), Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 800–835–4709 or 240– 402–8010, ocod@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Table of Contents [Docket No. FDA–2008–N–0567] I. Background: Priority Review Voucher Program II. Decision Not To Designate Pneumocystis Pneumonia A. Significant Market in Developed Nations B. Disproportionately Affects Poor and Marginalized Populations C. FDA Determination III. Process for Requesting Additional Diseases To Be Added to the List IV. Paperwork Reduction Act V. References I. Background: Priority Review Voucher Program Section 524 of the FD&C Act (21 U.S.C. 360n), which was added by section 1102 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), uses a PRV incentive to encourage the development of new PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 Average burden hours per response 0.5 Total burden hours 12,500 drugs, including biologics, for prevention and treatment of certain diseases that, in the aggregate, affect millions of people throughout the world. Further information about the tropical disease PRV program can be found in guidance for industry ‘‘Tropical Disease Priority Review Vouchers’’ (81 FR 69537, October 6, 2016, available at https:// www.federalregister.gov/documents/ 2015/08/20/2015-20554/designatingadditions-to-the-current-list-of-tropicaldiseases-in-the-federal-food-drug-andcosmetic). Additions to the statutory list of tropical diseases published in the Federal Register can be accessed at https://www.fda.gov/AboutFDA/Centers Offices/OfficeofMedicalProducts andTobacco/CDER/ucm534162.htm. In August 2015, FDA published a final order (80 FR 50559, August 20, 2015) (final order) designating Chagas disease and neurocysticercosis as tropical diseases. That final order also sets forth FDA’s interpretation of the statutory criteria for tropical disease designation and expands the list of tropical diseases under section 524(a)(3)(R) of the FD&C Act, which authorizes the FDA to designate by order ‘‘[a]ny other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations’’ as a tropical disease. FDA has applied its August 2015 criteria as set forth in the final order to analyze whether PCP meets the statutory criteria for addition to the tropical disease list. As discussed below, the Agency has determined that PCP does not meet the statutory criteria for designation as a ‘‘tropical disease’’ and thus will not add it to the list of tropical diseases whose applications may be eligible for a priority review voucher. II. Decision Not To Designate Pneumocystis Pneumonia FDA has considered all diseases submitted to the public docket (FDA– 2008–N–0567) between August 20, 2015, and June 20, 2018, as potential additions to the list of tropical diseases under section 524 of the FD&C Act, under the docket review process explained on the Agency’s website (see E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42895-42896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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