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, 71436-71437 [2014-28265]

Download as PDF 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. 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 self- rljohnson on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:30 Dec 01, 2014 Jkt 235001 addressed adhesive label to assist that office in processing your request. Submit electronic comments on the guidance to https://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 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://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. E:\FR\FM\02DEN1.SGM 02DEN1 Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices 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 https://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 https:// 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 rljohnson on DSK3VPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. Notice; establishment of docket; request for data, information, and comments. ACTION: The Food and Drug Administration (FDA), Center for Tobacco Products, is establishing a SUMMARY: VerDate Sep<11>2014 15:30 Dec 01, 2014 Jkt 235001 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 https:// 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 71437 discussion topics, including specific questions to be addressed at the workshop, can be found at https:// www.fda.gov/TobaccoProducts/ NewsEvents/ucm238308.htm. Interested persons may submit either electronic comments to this docket at https://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 https:// 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 Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: 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. SUMMARY: E:\FR\FM\02DEN1.SGM 02DEN1

Agencies

[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Pages 71436-71437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28265]



[[Page 71436]]

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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 self-addressed adhesive label to assist that office in 
processing your request.
    Submit electronic comments on the guidance to https://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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://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.

[[Page 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 https://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 https://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
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