4270 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 

Evaluation Report (PER) 009 (‘‘Target Organs 

for Lymphoma’’); PER 011 (‘‘K–25 [Technical 

Basis Document] TBD and TIB Revisions’’), 

PER 018 (‘‘Los Alamos National Laboratory 

TBD Revision, Rev. 00,’’), PER 031 (‘‘Y–12 

TBD Revisions’’), PER 042 (‘‘Linde Ceramic 

Plant TBD Revision’’), PER 043 (‘‘Internal 

and External Dosimetry Organs and IREP 

Model Selection by ICD–9 Code Revision’’), 

PER 045 (‘‘Aliquippa Forge TBD Revision’’), 

PER 0052 (‘‘Westinghouse Nuclear Fuels 

Division’’); Update on Review of ORAU 

Team Report 0053 (‘‘Stratified Co-Worker 

Sets’’); and a continuation of the commentresolution process for other dose 

reconstruction procedures under review by 

the Subcommittee. 

The agenda is subject to change as 

priorities dictate. 

Contact Person for More Information: 

Theodore Katz, Designated Federal Officer, 

NIOSH, CDC, 1600 Clifton Road NE., 

Mailstop E–20, Atlanta Georgia 30333, 

Telephone (513)533–6800, Toll Free 

1(800)CDC–INFO, Email ocas@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office. 

[FR Doc. 2015–01380 Filed 1–26–15; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Safety and Occupational Health Study 

Section (SOHSS), National Institute for 

Occupational Safety and Health 

(NIOSH or Institute) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following committee 

meeting. 

Times and Dates: 

8 a.m.–5 p.m., February 18, 2015 

(Closed) 

8 a.m.–5 p.m., February 19, 2015 

(Closed) 

8 a.m.–5 p.m., February 20, 2015 

(Closed) 

Place: Embassy Suites, 1900 Diagonal 

Road, Alexandria, Virginia 22314, 

Telephone: 703–684–5900, Fax: 703– 

684–0653. 

Purpose: The Safety and Occupational 

Health Study Section will review, 

discuss, and evaluate grant 

application(s) received in response to 

the Institute’s standard grants review 

and funding cycles pertaining to 

research issues in occupational safety 

and health, and allied areas. 

It is the intent of NIOSH to support 

broad-based research endeavors in 

keeping with the Institute’s program 

goals. This will lead to improved 

understanding and appreciation for the 

magnitude of the aggregate health 

burden associated with occupational 

injuries and illnesses, as well as to 

support more focused research projects, 

which will lead to improvements in the 

delivery of occupational safety and 

health services, and the prevention of 

work-related injury and illness. It is 

anticipated that research funded will 

promote these program goals. 

Matters for Discussion: The meeting 

will convene to address matters related 

to the conduct of Study Section 

business and for the study section to 

consider safety and occupational healthrelated grant applications. 

These portions of the meeting will be 

closed to the public in accordance with 

provisions set forth in Section 

552b(c)(4) and (6), Title 5 U.S.C., and 

the Determination of the Director, 

Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention, pursuant to Section 10(d) 

Public Law 92–463. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person For More Information: 

Price Connor, Ph.D., NIOSH Health 

Scientist, CDC, 2400 Executive Parkway, 

Mailstop E–20, Atlanta, Georgia 30345, 

Telephone: (404) 498–2511, Fax: (404) 

498–2571. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–01379 Filed 1–26–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Information Collections for the 

Interim Final Rule on Standards to 

Prevent, Detect, and Respond to Sexual 

Abuse and Sexual Harassment Involving 

Unaccompanied Children. 

OMB No.: New Collection. 

Description: In accordance with 

section 1101(c) of the Violence Against 

Women Reauthorization Act of 2013, 

Public Law 113–4 (VAWA 2013), the 

Administration for Children and 

families (ACF), Office of Refugee 

Resettlement (ORR) published an 

interim final rule (IFR) on December 24, 

2014 setting forth standards to prevent, 

detect, and respond to sexual abuse and 

sexual harassment involving 

unaccompanied children (UC). The IFR 

requires care provider facilities to 

collect, report, and retain information to 

ensure care provider facilities are 

properly preventing, detecting, and 

responding to all incidents of sexual 

abuse and sexual harassment that occur 

while a UC is in ORR care and custody. 

The proposed information collections 

solicit information to document a care 

provider facility’s efforts to do so. The 

proposed information collections 

associated with this rule include the 

following: 

(1) Sexual Abuse Significant Incident 

Report Form: ORR requires care 

provider facilities to use this form to 

report allegations related to sexual 

abuse and sexual harassment to ORR so 

that ORR may be able to monitor and 

track allegations of sexual abuse and 

sexual harassment as well as ensure 

proper follow-up. All care provider 

facility staff, volunteers, and contractors 

are required to report to ORR and thirdparties: any knowledge, suspicion, or 

information regarding an incident of 

sexual abuse or sexual harassment; 

retaliation; staff neglect or violation of 

responsibilities that may have 

contributed to an incident or retaliation; 

and allegations of sexual abuse or sexual 

harassment that occurred while the UC 

was at another care provider facility. 

(2) Assessment of Risk Form: ORR 

requires care provider facilities to use 

this form to assess a UC’s risk of being 

sexually abused or harassed or being 

sexually abusive or harassing other UC 

while in ORR care and custody. Care 

provider facilities will use this 

information to inform a UC’s service 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 4271 

assignments to reduce the risk of sexual 

abuse or sexual harassment by or upon 

a UC. 

(3) Care Provider Incident Review 

Form: ORR requires care provider 

facilities to collect data and prepare a 

report at the conclusion of every 

investigation of sexual abuse and sexual 

harassment that was determined to be 

substantiated or unsubstantiated but not 

unfounded to ensure proper steps are 

taken following an investigation or 

allegation of sexual abuse and/or sexual 

harassment. 

(4) Written policies: ORR requires care 

provider facilities to maintain written 

policies: mandating zero tolerance 

toward all forms of sexual abuse and 

sexual harassment and outlining the 

care provider facility’s approach to 

detecting, preventing, and responding to 

such conduct that include outside 

agencies (e.g. victim advocates, 

counselors) in the facility’s prevention 

and intervention protocols. 

(5) Previous misconduct of job 

applicants: ORR requires care provider 

facilities to solicit information from job 

applicants and employees considered 

for promotion and in any written selfevaluations conducted as part of 

performance evaluations of current 

employees about previous misconduct 

related to sexual abuse and sexual 

harassment. This information will be 

used to ensure any previous misconduct 

is reviewed prior to hiring or promoting 

a potential or existing employee. 

(6) Background checks: ORR requires 

care provider facilities to produce 

background investigation results and 

documentation to ORR upon request so 

that ORR can ensure background checks 

were conducted and to review 

background checks as necessary for 

potential employees at care provider 

facilities. 

(7) Reporting misconduct of former 

employees: ORR requires care provider 

facilities to provide information on 

substantiated allegations of sexual abuse 

or sexual harassment involving a former 

employee upon request from another 

care provider facility or institutional 

employer from whom such individual is 

seeking employment. ORR requires this 

so that an employee with substantiated 

allegations against him/her at one ORR 

care provider facility is not employed at 

a different ORR care provider facility. 

(8) Reporting to investigating 

authorities: ORR requires care provider 

facilities to report allegations of sexual 

abuse and sexual harassment, including 

allegations that occurred at another care 

provider facility, to ORR and all 

appropriate investigating authorities so 

allegations of sexual abuse and sexual 

harassment are investigated as 

appropriate. 

(9) Document retention: ORR requires 

care provider facilities to maintain 

documentation related to sexual abuse 

and sexual harassment for at least 10 

years. 

(10) MOUs with investigating 

authorities: ORR requires care provider 

facilities to maintain agreements or 

documentation showing attempts to 

enter into agreements with local law 

enforcement, State or local Child 

Protective Services, and State or local 

licensing agencies. This is required to 

document completion of the 

requirement under the IFR. 

(11) Training documentation: ORR 

requires care provider facilities to 

maintain written documentation that 

employees, contractors, volunteers, and 

medical and mental health practitioners 

employed or contracted by the care 

provider facility have completed 

required trainings on sexual abuse and 

sexual harassment prevention, 

detection, and response. This is 

required to document completion of the 

requirement under the IFR. 

(12) Information for UCs: ORR 

requires care provider facilities to 

provide information to UCs regarding 

the care provider facility’s zero 

tolerance policies, methods to report 

allegations, information on appropriate/ 

inappropriate relationships, and to 

document the provision of such 

information. This is required of care 

provider facilities so that UCs know 

what to report, how to report, and the 

policies of the facility. 

(13) MOUs with reporting entities: 

ORR requires care provider facilities to 

maintain agreements or document 

attempts to enter into agreements with 

external entities that can receive and 

immediately forward UC reports of 

sexual abuse and sexual harassment 

allegations to ORR. This is to ensure 

completion of the IFR requirements. 

(14) Grievance procedures: ORR 

requires care provider facilities to 

maintain written procedures for 

identifying and handling time-sensitive 

grievances that involve immediate 

threats to a child’s health, safety, or 

welfare related to sexual abuse and 

sexual harassment and reporting them 

to ORR. This is to ensure care provider 

facilities have procedures to handle 

time-sensitive grievances. 

(15) Agreements with community 

service providers: ORR requires care 

provider facilities must maintain 

agreements or document attempts to 

enter into agreements with community 

service providers to provide legal 

advocacy and confidential emotional 

support services for victims of sexual 

abuse and sexual harassment. This is to 

ensure that care provider facilities 

comply with the IFR requirements. 

(16) Third party reporting: ORR is 

required to establish a method to receive 

third-party reports of sexual abuse and 

sexual harassment that occur at ORR 

care provider facilities. This provides a 

way for third-parties to report 

allegations to ORR. 

(17) Reporting to parent/legal 

guardian: ORR requires care provider 

facilities to disclose allegations of 

sexual abuse and sexual harassment to 

the victim’s parents or legal guardian, 

except in cases where doing so would 

endanger the safety or well-being of the 

UC. 

(18) Reporting to attorney of record: 

ORR requires care provider facilities to 

disclose allegations of sexual abuse and 

sexual harassment to the victim’s 

attorney of record, if applicable. 

(19) Reporting staff, contractors, and 

volunteers to investigating authorities: 

ORR requires care provider facilities to 

report to law enforcement agencies and 

to any relevant state or local licensing 

agency any staff, contractor, or 

volunteer who was terminated or 

resigned because of a violation of care 

provider facility sexual abuse or sexual 

harassment policies or procedures. 

(20) Annual reports: ORR requires 

care provider facilities to conduct an 

annual review of all sexual abuse and 

sexual harassment investigations and 

provide the results to ORR so that ORR 

can gather aggregate data from all ORR 

care provider facilities. 

(21) Quarterly reporting: ORR requires 

the care provider facility’s PSA 

Compliance Manager to prepare a 

quarterly report for ORR compiling 

information and aggregate incidentbased sexual abuse and sexual 

harassment data in order for ORR to 

review data on a regular basis. 

(22) Other data: ORR requires care 

provider facilities to provide data or 

information to ORR upon request. 

(23) Audit report: ORR requires one 

audit report for each facility within the 

first three years of the rule’s publication 

and once every three years thereafter. 

Audits will certify that care provider 

facilities meet the standards required by 

the IFR. Audit reports will be provided 

to ORR so ORR can ensure that all care 

provider facilities are compliant with 

the IFR. 

Respondents: Care provider facility 

service staff, contractors, volunteers, 

family members and friends of UC, and 

auditors. 


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4272 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Sexual Abuse Significant Incident Report Form ................................... 2,430 ................ 1 or more .......... 0 .5 1,215 or more. 

Assessment of Risk Form ..................................................................... 57,500 .............. 1 ....................... 0 .17 9,775. 

Care Provider Incident Review Form .................................................... 2,430 ................ 1 ....................... 0 .5 1,215. 

Written policies ...................................................................................... 120 ................... 1 ....................... 2 240. 

Previous misconduct .............................................................................. 7,479 ................ 1 or more .......... 0 .33 2,468. 

Background checks ............................................................................... 748 ................... 1 or more .......... 0 .1 74.8. 

Reporting misconduct of former employees .......................................... 75 ..................... 1 ....................... 0 .33 25. 

Reporting to investigating authorities .................................................... 2,430 ................ 1 or more .......... 0 .33 802 or more. 

MOUs with investigating authorities ...................................................... 120 ................... 2 or more .......... 0 .33 79 or more. 

Training documentation ......................................................................... 7,479 ................ 1 ....................... 0 .17 1,271. 

Information for UCs ............................................................................... 57,500 .............. 1 ....................... 0 .25 14,375. 

MOUs with reporting entities ................................................................. 120 ................... 1 ....................... 0 .25 30. 

Grievance procedures ........................................................................... 120 ................... 1 ....................... 0 .5 60. 

Agreements with local service providers ............................................... 120 ................... 1 or more .......... 1 120. 

Third Party reporting .............................................................................. 73 or more ....... 1 ....................... 0 .25 18 or more. 

Disclosure to parent/guardian ................................................................ 2,430 ................ 1 ....................... 0 .17 413. 

Disclosure to atty of record ................................................................... 972 ................... 1 ....................... 0 .17 165. 

Reporting staff, contractors, and volunteers to investigating authorities 25 ..................... 1 ....................... 0 .25 6. 

Annual reports ....................................................................................... 120 ................... 1 ....................... 4 480. 

Quarterly reports .................................................................................... 120 ................... 4 ....................... 2 960. 

Other data .............................................................................................. 120 ................... 20 or more ........ 0 .25 600. 

Audit report ............................................................................................ 40 ..................... 1 ....................... 8 320. 

Estimated Total Annual Burden 

Hours: 34,713. 

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: infocollection@

acf.hhs.gov. 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 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. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–01372 Filed 1–26–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0194] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Biosimilars User 

Fee Cover Sheet; Form FDA 3792 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection in Form FDA 

3792, ‘‘Biosimilars User Fee Cover 

Sheet’’. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 30, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 


asabaliauskas on DSK5VPTVN1PROD with NOTICES