81_FR_94186 81 FR 93940 - Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level; Draft Guidance for Industry; Availability

81 FR 93940 - Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 246 (December 22, 2016)

Page Range93940-93941
FR Document2016-30781

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled, ``Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level.'' This draft guidance provides a recommended maximum level of 10 parts per million (ppm) for lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions) marketed in the United States. We consider the recommended maximum lead level to be achievable with the use of good manufacturing practices and consistent with the 10 ppm maximum lead level for similar products recommended by other countries, and we have concluded that the recommended maximum lead level would not pose a health risk.

Federal Register, Volume 81 Issue 246 (Thursday, December 22, 2016) 
[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 93940-93941]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2275]


Lead in Cosmetic Lip Products and Externally Applied Cosmetics: 
Recommended Maximum Level; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled, ``Lead in 
Cosmetic Lip Products and Externally Applied Cosmetics: Recommended 
Maximum Level.'' This draft guidance provides a recommended maximum 
level of 10 parts per million (ppm) for lead as an impurity in cosmetic 
lip products (such as lipsticks, lip glosses, and lip liners) and 
externally applied cosmetics (such as eye shadows, blushes, shampoos, 
and body lotions) marketed in the United States. We consider the 
recommended maximum lead level to be achievable with the use of good 
manufacturing practices and consistent with the 10 ppm maximum lead 
level for similar products recommended by other countries, and we have 
concluded that the recommended maximum lead level would not pose a 
health risk.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on this draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
February 21, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food

[[Page 93941]]

and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-2275 for ``Lead in Cosmetic Lip Products and Externally 
Applied Cosmetics: Recommended Maximum Level; Draft Guidance for 
Industry; Availability.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Division of Dockets Management. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Cosmetics and Colors, Center for Food Safety and Applied 
Nutrition, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Julie N. Barrows, Center for Food 
Safety and Applied Nutrition (HFS-106), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1119.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled, ``Lead in Cosmetic Lip Products and Externally Applied 
Cosmetics: Recommended Maximum Level.'' This draft guidance provides a 
recommended maximum level of 10 ppm for lead as an impurity in cosmetic 
lip products (such as lipsticks, lip glosses, and lip liners) and 
externally applied cosmetics (such as eye shadows, blushes, shampoos, 
and body lotions) marketed in the United States. FDA has concluded that 
a recommended maximum level of 10 ppm for lead as an impurity in 
cosmetic lip products and externally applied cosmetics would not pose a 
health risk. We consider the recommended maximum lead level to be 
achievable with the use of good manufacturing practices. Additionally, 
the recommended maximum level is consistent with the 10 ppm maximum 
lead level for similar products recommended by other countries. This 
draft guidance does not apply to topically applied products that are 
classified as drugs or to hair dyes that contain lead acetate as an 
ingredient.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on ``Lead in Cosmetic 
Lip Products and Externally Applied Cosmetics: Recommended Maximum 
Level.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Cosmetics/GuidanceRegulation/default.htm 
or https://www.regulations.gov. Use the FDA Web site listed in the 
previous sentence to find the most current version of the guidance.

    Dated: December 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30781 Filed 12-21-16; 8:45 am]
 BILLING CODE 4164-01-P

93940 Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices Council of State and Territorial Disease with the United States of America that nationally notifiable or be placed under Epidemiologists (CSTE), supported by are commonly referred to as ‘‘freely standardized surveillance, will not CDC, determines which reportable associated states’’); (2) case notification increase the burden since most case conditions should be designated data for histoplasmosis which is now notifications are submitted from already nationally notifiable and voluntarily under standardized surveillance; and (3) existing databases. The burden on the submitted to CDC so that information case notification data for all enteric states and cities is estimated to be 10 can be shared across jurisdictional Escherichia coli infections should any hours per response and the burden on boundaries and both surveillance and of them become nationally notifiable or the territories is estimated to be 5 hours prevention and control activities can be be placed under standardized per response. The total burden will coordinated at regional and national surveillance. CDC already has approval increase because of the request to levels. to receive case notification data for receive case notification data from the CDC requests a three-year approval for Shiga toxin-producing Escherichia coli freely associated states. The burden on a Revision for the National Notifiable (STEC) which is nationally notifiable. the freely associated states is estimated Diseases Surveillance System (NNDSS), Although this Revision includes case to be the same as the burden for the OMB Control No. 0920–0728, Expiration notifications that were not part of the territories, 5 hours per response. This is Date 01/31/2019. This Revision includes last NNDSS Revision, the estimate of the because the methods and systems that requests for approval to receive: (1) Case average burden per response based on the freely associated states use to send notification data from the Federated the burden tables from all of the case notification data to CDC are nearly States of Micronesia, the Republic of the consolidated applications for states, the same as the territories. Marshall Islands, and the Republic of cities, and territories has not changed. There will be no costs to respondents Palau (independent nations that operate The addition of new diseases and other than their time. The estimated under a Compact of Free Association conditions, should they become annual burden is 29,120 hours. ESTIMATED ANNUALIZED BURDEN HOURS Number of Avg. burden Number of Total burden Type of respondents Form name responses per per response respondents (in hours) respondent (in hours) States ................................................ Weekly and Annual .......................... 50 52 10 26,000 Territories .......................................... Weekly and Annual .......................... 5 52 5 1,300 Freely Associated States .................. Weekly and Annual .......................... 3 52 5 780 Cities ................................................. Weekly and Annual .......................... 2 52 10 1,040 Total ........................................... ........................................................... ........................ ........................ ........................ 29,120 Leroy A. Richardson, level of 10 parts per million (ppm) for instructions for submitting comments. Chief, Information Collection Review Office, lead as an impurity in cosmetic lip Comments submitted electronically, Office of Scientific Integrity, Office of the products (such as lipsticks, lip glosses, including attachments, to https:// Associate Director for Science, Office of the and lip liners) and externally applied www.regulations.gov will be posted to Director, Centers for Disease Control and cosmetics (such as eye shadows, the docket unchanged. Because your Prevention. blushes, shampoos, and body lotions) comment will be made public, you are [FR Doc. 2016–30779 Filed 12–21–16; 8:45 am] marketed in the United States. We solely responsible for ensuring that your BILLING CODE 4163–18–P consider the recommended maximum comment does not include any lead level to be achievable with the use confidential information that you or a of good manufacturing practices and third party may not wish to be posted, DEPARTMENT OF HEALTH AND consistent with the 10 ppm maximum such as medical information, your or HUMAN SERVICES lead level for similar products anyone else’s Social Security number, or recommended by other countries, and confidential business information, such Food and Drug Administration as a manufacturing process. Please note we have concluded that the [Docket No. FDA–2014–D–2275] recommended maximum lead level that if you include your name, contact would not pose a health risk. information, or other information that Lead in Cosmetic Lip Products and DATES: Although you can comment on identifies you in the body of your Externally Applied Cosmetics: any guidance at any time (see 21 CFR comments, that information will be Recommended Maximum Level; Draft 10.115(g)(5)), to ensure that we consider posted on https://www.regulations.gov. Guidance for Industry; Availability • If you want to submit a comment your comment on this draft guidance with confidential information that you AGENCY: Food and Drug Administration, before we begin work on the final do not wish to be made available to the HHS. version of the guidance, submit either public, submit the comment as a electronic or written comments on the ACTION: Notice of availability. written/paper submission and in the draft guidance by February 21, 2017. manner detailed (see ‘‘Written/Paper SUMMARY: The Food and Drug sradovich on DSK3GMQ082PROD with NOTICES ADDRESSES: You may submit comments Submissions’’ and ‘‘Instructions’’). Administration (FDA or we) is as follows: announcing the availability of a draft Written/Paper Submissions Electronic Submissions guidance for industry entitled, ‘‘Lead in Submit written/paper submissions as Cosmetic Lip Products and Externally Submit electronic comments in the follows: Applied Cosmetics: Recommended following way: • Mail/Hand delivery/Courier (for Maximum Level.’’ This draft guidance • Federal eRulemaking Portal: written/paper submissions): Division of provides a recommended maximum https://www.regulations.gov. Follow the Dockets Management (HFA–305), Food VerDate Sep<11>2014 17:40 Dec 21, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\22DEN1.SGM 22DEN1

Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices 93941 and Drug Administration, 5630 Fishers and/or go to the Division of Dockets II. Electronic Access Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. Persons with access to the Internet • For written/paper comments 1061, Rockville, MD 20852. may obtain the draft guidance at either submitted to the Division of Dockets Submit written requests for single http://www.fda.gov/Cosmetics/ Management, FDA will post your copies of the draft guidance to the Office GuidanceRegulation/default.htm or comment, as well as any attachments, of Cosmetics and Colors, Center for https://www.regulations.gov. Use the except for information submitted, Food Safety and Applied Nutrition, FDA Web site listed in the previous marked and identified, as confidential, 5001 Campus Dr., College Park, MD sentence to find the most current if submitted as detailed in 20740. Send two self-addressed version of the guidance. ‘‘Instructions.’’ Instructions: All submissions received adhesive labels to assist that office in Dated: December 16, 2016. must include the Docket No. FDA– processing your requests. See the Leslie Kux, 2014–D–2275 for ‘‘Lead in Cosmetic Lip SUPPLEMENTARY INFORMATION section for Associate Commissioner for Policy. Products and Externally Applied electronic access to the draft guidance [FR Doc. 2016–30781 Filed 12–21–16; 8:45 am] Cosmetics: Recommended Maximum document. BILLING CODE 4164–01–P Level; Draft Guidance for Industry; Availability.’’ Received comments will FOR FURTHER INFORMATION CONTACT: Julie be placed in the docket and, except for N. Barrows, Center for Food Safety and Applied Nutrition (HFS–106), Food and DEPARTMENT OF HEALTH AND those submitted as ‘‘Confidential HUMAN SERVICES Submissions,’’ publicly viewable at Drug Administration, 5001 Campus Dr., https://www.regulations.gov or at the College Park, MD 20740, 240–402–1119. Food and Drug Administration Division of Dockets Management SUPPLEMENTARY INFORMATION: between 9 a.m. and 4 p.m., Monday [Docket No. FDA–2016–N–2474] through Friday. I. Background • Confidential Submissions—To Agency Information Collection submit a comment with confidential FDA is announcing the availability of Activities; Submission for Office of information that you do not wish to be a draft guidance for industry entitled, Management and Budget Review; made publicly available, submit your ‘‘Lead in Cosmetic Lip Products and Comment Request; Reporting comments only as a written/paper Externally Applied Cosmetics: Associated With Designated New submission. You should submit two Recommended Maximum Level.’’ This Animal Drugs for Minor Use and Minor copies total. One copy will include the draft guidance provides a recommended Species information you claim to be confidential maximum level of 10 ppm for lead as an with a heading or cover note that states impurity in cosmetic lip products (such AGENCY: Food and Drug Administration, ‘‘THIS DOCUMENT CONTAINS as lipsticks, lip glosses, and lip liners) HHS. CONFIDENTIAL INFORMATION.’’ We and externally applied cosmetics (such ACTION: Notice. will review this copy, including the as eye shadows, blushes, shampoos, and claimed confidential information, in our body lotions) marketed in the United SUMMARY: The Food and Drug consideration of comments. The second States. FDA has concluded that a Administration (FDA) is announcing copy, which will have the claimed recommended maximum level of 10 that a proposed collection of confidential information redacted/ ppm for lead as an impurity in cosmetic information has been submitted to the blacked out, will be available for public lip products and externally applied Office of Management and Budget viewing and posted on https:// cosmetics would not pose a health risk. (OMB) for review and clearance under www.regulations.gov. Submit both We consider the recommended the Paperwork Reduction Act of 1995. copies to the Division of Dockets maximum lead level to be achievable DATES: Fax written comments on the Management. If you do not wish your with the use of good manufacturing collection of information by January 23, name and contact information to be practices. Additionally, the 2017. made publicly available, you can recommended maximum level is ADDRESSES: To ensure that comments on provide this information on the cover consistent with the 10 ppm maximum the information collection are received, sheet and not in the body of your lead level for similar products OMB recommends that written comments and you must identify this recommended by other countries. This comments be faxed to the Office of information as ‘‘confidential.’’ Any draft guidance does not apply to Information and Regulatory Affairs, information marked as ‘‘confidential’’ topically applied products that are OMB, Attn: FDA Desk Officer, FAX: will not be disclosed except in classified as drugs or to hair dyes that 202–395–7285, or emailed to oira_ accordance with 21 CFR 10.20 and other submission@omb.eop.gov. All contain lead acetate as an ingredient. applicable disclosure law. For more comments should be identified with the information about FDA’s posting of This draft guidance is being issued OMB control number 0910–0605. Also comments to public dockets, see 80 FR consistent with FDA’s good guidance include the FDA docket number found 56469, September 18, 2015, or access practices regulation (21 CFR 10.115). in brackets in the heading of this the information at: http://www.fda.gov/ The draft guidance, when finalized, will document. regulatoryinformation/dockets/ represent FDA’s current thinking on default.htm. ‘‘Lead in Cosmetic Lip Products and FOR FURTHER INFORMATION CONTACT: FDA Docket: For access to the docket to Externally Applied Cosmetics: PRA Staff, Office of Operations, Food sradovich on DSK3GMQ082PROD with NOTICES read background documents or the Recommended Maximum Level.’’ It and Drug Administration, Three White electronic and written/paper comments does not establish any rights for any Flint North, 10A63, 11601 Landsdown received, go to https:// person and is not binding on FDA or the St., North Bethesda, MD 20852, www.regulations.gov and insert the public. You can use an alternative PRAStaff@fda.hhs.gov. docket number, found in brackets in the approach if it satisfies the requirements SUPPLEMENTARY INFORMATION: In heading of this document, into the of the applicable statutes and compliance with 44 U.S.C. 3507, FDA ‘‘Search’’ box and follow the prompts regulations. has submitted the following proposed VerDate Sep<11>2014 17:40 Dec 21, 2016 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\22DEN1.SGM 22DEN1


Document Created: 2016-12-21 23:52:26
Document Modified: 2016-12-21 23:52:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017.
ContactJulie N. Barrows, Center for Food Safety and Applied Nutrition (HFS-106), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1119.
FR Citation81 FR 93940 
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