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
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 4273 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Biosimilars User Fee Cover Sheet; Form 

FDA 3792 (OMB Control Number 0910– 

0718)—Extension 

The Patient Protection and Affordable 

Care Act (Pub. L. 111–148) contains a 

subtitle called the Biologics Price 

Competition and Innovation Act of 2009 

(Title VII Subtitle A) (BPCI Act) that 

amends the Public Health Service Act 

(42 U.S.C. 262) (PHS Act) and other 

statutes to create an abbreviated 

approval pathway for biological 

products shown to be biosimilar to or 

interchangeable with an FDA-licensed 

reference biological product. Section 

351(k) of the PHS Act, added by the 

BPCI Act, allows a company to submit 

an application for licensure of a 

biosimilar or interchangeable biological 

product. The BPCI Act also amends 

section 735 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379g) to 

include 351(k) applications in the 

definition of ‘‘human drug application’’ 

for the purposes of the prescription drug 

user fee provisions. The BPCI Act 

directs FDA to develop 

recommendations for a biosimilar 

biological product user fee program for 

fiscal years 2013 through 2017. FDA’s 

recommendations for a biosimilar 

biological product user fee program 

were submitted to Congress on January 

13, 2012. 

FDA’s biosimilar biological product 

user fee program requires FDA to assess 

and collect user fees for certain 

meetings concerning biosimilar 

biological product development (BPD 

meetings), investigational new drug 

applications (INDs) intended to support 

a biosimilar biological product 

application, and biosimilar biological 

product applications and supplements. 

Form FDA 3792, the Biosimilars User 

Fee Cover Sheet, requests the minimum 

necessary information to determine the 

amount of the fee required, and to 

account for and track user fees. The 

form provides a cross-reference of the 

fees submitted for a submission with the 

actual submission by using a unique 

number tracking system. The 

information collected is used by FDA’s 

Center for Drug Evaluation and Research 

and Center for Biologics Evaluation and 

Research to initiate the administrative 

screening of biosimilar biological 

product INDs, applications, and 

supplements, and to account for and 

track user fees associated with BPD 

meetings. 

Respondents to this collection of 

information are manufacturers of 

biosimilar biological product 

candidates. Based on the number of 

Form FDA 3792s we have received, we 

estimate the burden of this collection of 

information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Biosimilars User Fee Cover Sheet; Form FDA 3792 .. 20 1 20 0.50 (30 minutes) ... 10 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: January 21, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01404 Filed 1–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1414] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Class II Special 

Controls Guidance Document: 

Labeling of Natural Rubber Latex 

Condoms 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 

26, 2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0633. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Class II Special Controls Guidance 

Document: Labeling for Natural Rubber 

Latex Condoms Classified Under 21 

CFR 884.5300—(OMB Control Number 

0910–0633)—Extension 

Under the Medical Device 

Amendments of 1976 (Pub. L. 94–295), 

class II devices were defined as those 

devices for which there was insufficient 

information to show that general 

controls themselves would provide a 

reasonable assurance of safety and 

effectiveness but for which there was 

sufficient information to establish 

performance standards to provide such 

assurance. 

Condoms without spermicidal 

lubricant containing nonoxynol 9 are 


asabaliauskas on DSK5VPTVN1PROD with NOTICES