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
4274 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 

classified in class II. They were 

originally classified before the 

enactment of provisions of the Safe 

Medical Devices Act of 1990 (Pub. L. 

101–629), which broadened the 

definition of class II devices and now 

permit FDA to establish special controls 

beyond performance standards, 

including guidance documents, to help 

provide reasonable assurance of the 

safety and effectiveness of such devices. 

In December 2000, Congress enacted 

Public Law 106–554, which directed 

FDA to ‘‘reexamine existing condom 

labels’’ and ‘‘determine whether the 

labels are medically accurate regarding 

the overall effectiveness or lack of 

effectiveness in preventing sexually 

transmitted diseases * * *.’’ In 

response, FDA recommended labeling 

intended to provide important 

information for condom users, including 

the extent of protection provided by 

condoms against various types of 

sexually transmitted diseases. 

Respondents to this collection of 

information are manufacturers and 

repackagers of male condoms made of 

natural rubber latex without spermicidal 

lubricant. FDA expects approximately 

five new manufacturers or repackagers 

to enter the market yearly and to 

collectively have a third-party 

disclosure burden of 60 hours. The 

number of respondents cited in table 1 

of this document is based on FDA’s 

database of premarket submissions and 

the electronic registration and listing 

database. The average burden per 

disclosure was derived from a study 

performed for FDA by Eastern Research 

Group, Inc., an economic consulting 

firm, to estimate the impact of the 1999 

over-the-counter (OTC) human drug 

labeling requirements final rule (64 FR 

13254, March 17, 1999). Because the 

packaging requirements for condoms are 

similar to those of many OTC drugs, we 

believe the burden to design the labeling 

for OTC drugs is an appropriate proxy 

for the estimated burden to design 

condom labeling. 

The special controls guidance 

document also refers to previously 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485; the 

collections of information in 21 CFR 

part 807 subpart E have been approved 

under OMB control number 0910–0120; 

and the collections of information in 21 

CFR part 820 have been approved under 

OMB control number 0910–0073. 

The collection of information under 

21 CFR 801.437 does not constitute a 

‘‘collection of information’’ under the 

Paperwork Reduction Act of 1995. 

Rather, it is a ‘‘public disclosure of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of disclosure to the public’’ 

(5 CFR 1320.3(c)(2)). 

In the Federal Register of October 15, 

2014 (79 FR 61874), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Class II Special Controls Guidance Document: Labeling for Natural 

Rubber Latex Condoms Classified Under 21 CFR 884.5300 ............. 5 1 5 12 60 

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. 2015–01403 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–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

038 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the Agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA Recognized 

Consensus Standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 038’’ (Recognition List 

Number: 038), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit either electronic or 

written comments concerning this 

document at any time. See section VII 

of this document for the effective date 

of the recognition of standards 

announced in this document. 

ADDRESSES: An electronic copy of 

Recognition List Number: 038 is 

available on the Internet at http://

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. See section 

VI of this document for electronic access 

to the searchable database for the 

current list of FDA recognized 

consensus standards, including 

Recognition List Number: 038 

modifications and other standards 

related information. 

Submit written requests for a single 

copy of the document entitled 

‘‘Modifications to the List of Recognized 

Standards, Recognition List Number: 

038’’ to the Division of Industry and 

Consumer Education, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4613, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–847–8149. 

Submit electronic comments on this 

document to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3632, Silver Spring, 


asabaliauskas on DSK5VPTVN1PROD with NOTICES