Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level; Draft Guidance for Industry; Availability, 93940-93941 [2016-30781]
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Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices
Council of State and Territorial Disease
Epidemiologists (CSTE), supported by
CDC, determines which reportable
conditions should be designated
nationally notifiable and voluntarily
submitted to CDC so that information
can be shared across jurisdictional
boundaries and both surveillance and
prevention and control activities can be
coordinated at regional and national
levels.
CDC requests a three-year approval for
a Revision for the National Notifiable
Diseases Surveillance System (NNDSS),
OMB Control No. 0920–0728, Expiration
Date 01/31/2019. This Revision includes
requests for approval to receive: (1) Case
notification data from the Federated
States of Micronesia, the Republic of the
Marshall Islands, and the Republic of
Palau (independent nations that operate
under a Compact of Free Association
nationally notifiable or be placed under
standardized surveillance, will not
increase the burden since most case
notifications are submitted from already
existing databases. The burden on the
states and cities is estimated to be 10
hours per response and the burden on
the territories is estimated to be 5 hours
per response. The total burden will
increase because of the request to
receive case notification data from the
freely associated states. The burden on
the freely associated states is estimated
to be the same as the burden for the
territories, 5 hours per response. This is
because the methods and systems that
the freely associated states use to send
case notification data to CDC are nearly
the same as the territories.
There will be no costs to respondents
other than their time. The estimated
annual burden is 29,120 hours.
with the United States of America that
are commonly referred to as ‘‘freely
associated states’’); (2) case notification
data for histoplasmosis which is now
under standardized surveillance; and (3)
case notification data for all enteric
Escherichia coli infections should any
of them become nationally notifiable or
be placed under standardized
surveillance. CDC already has approval
to receive case notification data for
Shiga toxin-producing Escherichia coli
(STEC) which is nationally notifiable.
Although this Revision includes case
notifications that were not part of the
last NNDSS Revision, the estimate of the
average burden per response based on
the burden tables from all of the
consolidated applications for states,
cities, and territories has not changed.
The addition of new diseases and
conditions, should they become
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
States ................................................
Territories ..........................................
Freely Associated States ..................
Cities .................................................
Total ...........................................
Weekly
Weekly
Weekly
Weekly
10
5
5
10
26,000
1,300
780
1,040
...........................................................
........................
........................
........................
29,120
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
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
ACTION:
Notice of availability.
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
SUMMARY:
VerDate Sep<11>2014
17:40 Dec 21, 2016
Total burden
(in hours)
52
52
52
52
BILLING CODE 4163–18–P
Jkt 241001
Annual
Annual
Annual
Annual
Avg. burden
per response
(in hours)
50
5
3
2
[FR Doc. 2016–30779 Filed 12–21–16; 8:45 am]
and
and
and
and
Number of
responses per
respondent
..........................
..........................
..........................
..........................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
AGENCY:
Number of
respondents
Form name
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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
E:\FR\FM\22DEN1.SGM
22DEN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices
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: https://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
VerDate Sep<11>2014
17:40 Dec 21, 2016
Jkt 241001
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.
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.
93941
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://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
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2016–N–2474]
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.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reporting
Associated With Designated New
Animal Drugs for Minor Use and Minor
Species
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 January 23,
2017.
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 0910–0605. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\22DEN1.SGM
22DEN1
Agencies
[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 93940-93941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30781]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
https://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 https://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