71436 Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0168] 

Recommendations for Labeling 

Medical Products To Inform Users That 

the Product or Product Container Is 

Not Made With Natural Rubber Latex; 

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 the guidance entitled 

‘‘Recommendations for Labeling 

Medical Products to Inform Users That 

the Product or Product Container Is Not 

Made With Natural Rubber Latex; 

Guidance for Industry and Food and 

Drug Administration Staff.’’ The 

purpose of this guidance is to make 

recommendations on the appropriate 

language to include in the labeling of a 

medical product to convey that natural 

rubber latex was not used as a material 

in the manufacture of the product, 

product container, and/or packaging. 

FDA is concerned that statements 

submitted for inclusion in medical 

product labeling, such as ‘‘latex-free,’’ 

‘‘does not contain natural rubber latex,’’ 

or ‘‘does not contain latex’’ are not 

accurate because it is not possible to 

reliably assure that there is a complete 

absence of the allergens associated with 

hypersensitivity reactions to natural 

rubber latex in the medical product. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome 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 a 

single hard copy of the guidance 

document entitled ‘‘Recommendations 

for Labeling Medical Products to Inform 

Users That the Product or Product 

Container Is Not Made With Natural 

Rubber Latex; Guidance for Industry 

and Food and Drug Administration 

Staff’’ 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: 

Michael T. Bailey, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G120, Silver Spring, 

MD 20993–0002, 301–796–6530, email: 

Michael.Bailey@fda.hhs.gov; or Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Contact with medical products 

containing natural rubber has been 

associated with anaphylaxis in 

individuals allergic to natural rubber 

latex proteins. Therefore, all medical 

devices and device packaging composed 

of or containing natural rubber latex, 

dry natural rubber, and synthetic latex 

or synthetic rubber that contains natural 

rubber in the formulation are required to 

include a specific caution statement 

regarding the presence of these 

materials (e.g., ‘‘Caution: This Product 

Contains Natural Rubber Latex Which 

May Cause Allergic Reactions’’) in 

device labeling (21 CFR 801.437). The 

biological products regulations require 

that the package label or package insert 

declare the presence of known 

sensitizing substances, but do not 

specifically mention natural rubber 

latex (21 CFR 610.61(l)). Specific 

regulations for labeling of natural rubber 

latex content in medical products or 

their containers and/or packaging do not 

exist for drugs or veterinary products. 

At this time, there are no regulations 

requiring the labeling of a medical 

product to state that natural rubber latex 

was not used as a material in the 

manufacture of a medical product, 

medical product container, or medical 

product packaging. However, some 

manufacturers have included the 

promotional statements ‘‘latex-free’’ or 

‘‘does not contain latex’’ in medical 

product labeling to inform users that 

natural rubber latex, dry natural rubber, 

or synthetic derivatives of natural 

rubber latex were not used. FDA 

believes that these labeling statements 

are not sufficiently specific, not 

necessarily scientifically accurate, and 

may be misunderstood or applied too 

widely and, therefore, are inappropriate 

to be included in medical product 

labeling. Use of these terms may give 

users allergic to natural rubber latex a 

false sense of security when using a 

medical product. This guidance 

document provides recommendations 

for scientifically accurate labeling that 

can be used by manufacturers who wish 

to convey that natural rubber latex was 

not used as a material in the 

manufacture of a medical product, 

medical product container, or medical 

product packaging. 

The draft of this guidance was made 

available in the Federal Register on 

March 11, 2013 (78 FR 15370). The 

comment period closed on June 10, 

2013. A number of comments were 

received from the public, all of which 

the Agency considered carefully as it 

finalized the guidance and made 

appropriate changes. Any changes to the 

guidance were minor and made to 

clarify statements in the draft guidance. 

II. Significance of Guidance 

This 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 labeling medical 

products to inform users that a product, 

product container, or product packaging 

was not made with natural rubber latex. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Recommendations for Labeling 

Medical Products to Inform Users That 

the Product or Product Container Is Not 

Made With Natural Rubber Latex; 

Guidance for Industry and Food and 

Drug Administration Staff’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1768 to identify the 

guidance you are requesting. 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices 71437 

IV. Paperwork Reduction Act of 1995 

This guidance refers to currently 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520) (the PRA). The collections of 

information in 21 CFR part 801 are 

approved under OMB control number 

0910–0485 and the collections of 

information in 21 CFR part 610, subpart 

G, are approved under OMB control 

number 0910–0338. 

The labeling provisions recommended 

in this guidance are not subject to 

review by OMB because they do not 

constitute a ‘‘collection of information’’ 

under the PRA. Rather, the 

recommended labeling 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)). 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: November 25, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28265 Filed 12–1–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1936] 

Establishment of a Public Docket; 

Electronic Cigarettes and the Public 

Health Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of docket; 

request for data, information, and 

comments. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for 

Tobacco Products, is establishing a 

public docket in conjunction with the 

first public workshop to gather scientific 

information about electronic cigarettes 

(e-cigarettes) as announced in Docket 

No. FDA–2014–N–0001–0079. 

Regardless of attendance at the public 

workshop, interested parties are invited 

to submit comments, supported by 

research and data, regarding electronic 

cigarettes and the public health. 

DATES: Submit written or electronic 

comments by April 15, 2015. 

ADDRESSES: Submit electronic 

comments 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: 

Caryn Cohen, Office of Science, Center 

for Tobacco Products, Food and Drug 

Administration, Document Control 

Center, Bldg. 71, Rm. G335, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 1–877–287–1373, email: 

workshop.CTPOS@fda.hhs.gov. 

I. Background 

On September 17, 2014, FDA 

announced a public workshop to gather 

information about e-cigarettes and the 

public health (Electronic Cigarettes and 

the Public Health; Public Workshop; 79 

FR 55815, September 17, 2014, Docket 

No. FDA–2014–N–0001). The focus of 

the workshop is product science 

(specifically device designs and 

characteristics, and e-liquid and aerosol 

constituents), product packaging, 

constituent labeling, and environmental 

impact. FDA intends to follow the first 

workshop with two additional ecigarette workshops; one on individual 

health effects and one on population 

health effects. As stated in the Federal 

Register notice of the public workshop, 

the workshops are not intended to 

inform the Agency’s deeming 

rulemaking. The workshops are 

intended to better inform FDA about 

these products. Should the Agency 

move forward as proposed to regulate ecigarettes, additional information about 

the products would assist the Agency in 

carrying out its responsibilities under 

the law. 

II. Submission of Comments 

Regardless of attendance at the public 

workshop, interested parties are invited 

to submit comments, supported by 

research and data, regarding e-cigarettes 

and the public health. Information 

related to workshop presentations and 

discussion topics, including specific 

questions to be addressed at the 

workshop, can be found at http://

www.fda.gov/TobaccoProducts/

NewsEvents/ucm238308.htm. 

Interested persons may submit either 

electronic comments to this docket at 

http://www.regulations.gov or written 

comments to the Division of Dockets 

Management (see ADDRESSES). It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: November 25, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28261 Filed 12–1–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than January 2, 2015. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 


rljohnson on DSK3VPTVN1PROD with NOTICES