Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 42895 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden 

hours 

FACES 2019 Classroom sampling form from Head Start 

staff ................................................................................... 360 120 1 0.17 20 

FACES 2019 Child roster form from Head Start staff ......... 120 40 1 0.33 13 

FACES 2019 Parent consent form ...................................... 2,400 800 1 0.17 136 

FACES 2019 Head Start parent survey .............................. 2,400 800 2 0.42 672 

FACES 2019 Head Start child assessment ........................ 2,400 800 2 0.75 1,200 

FACES 2019 Head Start teacher child report ..................... 240 80 20 0.17 272 

FACES 2019 Head Start teacher survey ............................ 720 240 1 0.50 120 

FACES 2019 Head Start program director survey .............. 180 60 1 0.50 30 

FACES 2019 Head Start center director survey ................. 360 120 1 0.50 60 

AI/AN FACES 2019 Classroom sampling form from Head 

Start staff .......................................................................... 37 13 1 0.17 2 

AI/AN FACES 2019 Child roster form from Head Start 

staff ................................................................................... 37 13 1 0.33 4 

AI/AN FACES 2019 Parent consent form ........................... 800 267 1 0.17 45 

AI/AN FACES 2019 Head Start parent survey .................... 800 267 2 0.50 267 

AI/AN FACES 2019 Head Start child assessment .............. 800 267 2 0.75 401 

AI/AN FACES 2019 Head Start teacher child report .......... 80 27 20 0.17 92 

AI/AN FACES 2019 Head Start teacher survey .................. 80 27 1 0.58 16 

AI/AN FACES 2019 Head Start program director survey ... 22 8 1 0.33 3 

AI/AN FACES 2019 Head Start center director survey ....... 37 13 1 0.33 4 

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 

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

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

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 


daltland on DSKBBV9HB2PROD with NOTICES
42896 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 

ANNUAL BURDEN ESTIMATES—Continued 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

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: 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 

[Docket No. FDA–2008–N–0567] 

Notice of Decision Not To Designate 

Pneumocystis Pneumonia as a 

Tropical Disease 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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 

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 

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 

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 


daltland on DSKBBV9HB2PROD with NOTICES