61874 Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0539. The 

approval expires on August 31, 2017. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24444 Filed 10–14–14; 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; Proposed Collection; 

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 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 for the 

labeling of natural rubber latex 

condoms. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 15, 2014. 

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, 

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. 

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 

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, among 

other provisions, 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 5 

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 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. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 61875 

The collection of information under 

§ 801.437 does not constitute a 

‘‘collection of information’’ under the 

PRA. 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)). 

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: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24445 Filed 10–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0114] 

Distinguishing Medical Device Recalls 

From Medical Device Enhancements; 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled, 

‘‘Distinguishing Medical Device Recalls 

From Medical Device Enhancements.’’ 

This guidance is intended to clarify 

when a potential change to a device is 

a medical device recall, distinguish 

those instances from product 

enhancements, and explain reporting 

requirements. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for 

single copies of the guidance document 

entitled, ‘‘Distinguishing Medical 

Device Recalls From Medical Device 

Enhancements’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

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

office in processing your request. 

Submit electronic comments on the 

guidance 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: 

Ronny Brown, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2654, Silver Spring, 

MD 20993–0002, 301–796–6163. 

I. Background 

Defects or performance failures of 

marketed medical devices can pose 

serious risks to public health. The recall 

process serves both to correct the device 

defects and to notify users of potential 

risks and steps to minimize the impact 

of device failure or improper function. 

The recall process establishes a 

mechanism for firms that produce and 

market medical devices to take timely 

action to correct or remove violative 

devices. 

When a firm’s recall process is 

operating effectively, the firm identifies 

a device defect or failure, determines 

that a recall is appropriate, and triggers 

the initiation of the recall process. 

However, firms may have trouble 

identifying whether a change to a device 

meets the definition of a recall, the 

appropriate scope of a recall, and when 

FDA should be notified of a recall. 

These issues can result in delays in 

notifying the public about unsafe 

medical devices. 

FDA also recognizes that continuous 

improvement activities, as part of an 

effective quality system, often have a 

favorable impact on medical device 

safety and are part of ongoing efforts to 

design and manufacture devices that 

meet the needs of the user and patient. 

When a new iteration of a device has 

improved design, for example, this does 

not necessarily mean that the prior 

version of the device should be recalled. 

Such changes may be appropriately 

characterized instead as product 

enhancements. In addition to 

determining whether a proposed change 

to a marketed device meets the 

definition of a device recall or a product 

enhancement, a firm must assess 

whether it is required to report the 

change to FDA. 

In the Federal Register of February 

22, 2013 (78 FR 12329), FDA announced 

the availability of the draft guidance 

document. Interested persons were 

invited to comment by May 23, 2013. 

Multiple comments were received with 

recommendations pertaining to three 

main areas: (1) Clarification of 

definitions; (2) requests for more 

examples; and (3) clarification of 

reporting obligations pertaining to 21 

CFR part 806. In response to these 

comments, FDA revised the guidance 

document to enhance clarity through 

the inclusion of multiple new examples. 

Some previously-included examples 

were deleted or reframed for improved 

clarity, and some content was removed 

since it did not enhance clarity and in 

some cases led to confusion. The 

guidance as revised provides more 

succinct information about the 

distinctions between medical device 

recalls and medical device 

enhancements and related reporting 

obligations. The guidance is organized 

in a question-and-answer format, 

providing responses to questions that 

FDA believes are helpful in properly 

identifying medical device recalls and 

applying reporting requirements. 

II. Significance of Guidance 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on the difference 

between a medical device recall and a 


tkelley on DSK3SPTVN1PROD with NOTICES