Availability of FDA Statement Added to the Docket for Public Meeting Related to Cosmetic Products Containing Talc, 51035 [2020-18181]
Download as PDF
<![CDATA[
51035
Federal Register / Vol. 85, No. 161 / Wednesday, August 19, 2020 / Notices
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates;
(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.
The Certification of Maintenance of
Effort under Title III and Certification of
Long-Term Care Ombudsman (LTCO)
Program Expenditures provide
statutorily required information
regarding each state’s contribution to
programs funded under the Older
Americans Act and compliance with
legislative requirements, pertinent
Federal regulations, and other
applicable instructions and guidelines
issued by ACL. This information will be
used for Federal oversight of Title III
Programs and Long Term Care
Ombudsman Program expenditures.
The proposed data collection tools are
located on the ACL website, please visit
for review and comment on this
Number of
respondents
Respondent/data collection activity
Estimated Program Burden
ACL estimates the burden associated
with this collection of information as
follows: 56 State Agencies on Aging
respond annually, and it takes each
agency an average of one half (.5) hour
per State agency per year to complete
each form for a total of twenty-eight
hours for all state agencies annually.
The half hour estimate is based on prior
years’ experience with States in
completing these forms.
Responses per
respondent
Hours per
response
Annual burden
hours
Certification on Maintenance of Effort under Title III .....................................
Certification of Long-Term Care Ombudsman Program Expenditures .........
56
56
1
1
.5
.5
28
28
Total ........................................................................................................
112
2
1
56
Dated: August 13, 2020.
Lance Robertson,
ACL Administrator and Assistant Secretary
for Aging.
group (the Interagency Working Group
on Asbestos in Consumer Products or
IWGACP).
FOR FURTHER INFORMATION CONTACT:
Deborah Smegal, Office of Cosmetics
and Colors, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5100 Campus Dr.,
College Park, MD 20740, 240–402–1130.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2020–18111 Filed 8–18–20; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0025]
Availability of FDA Statement Added to
the Docket for Public Meeting Related
to Cosmetic Products Containing Talc
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
statement added to the docket for the
public meeting entitled ‘‘Testing
Methods for Asbestos in Talc and
Cosmetic Products Containing Talc’’ to
address information provided in
connection with the public meeting.
FDA held the public meeting on
February 4, 2020, to discuss and obtain
scientific data and information on topics
related to cosmetic products with talc as
an ingredient, specifically, testing
methodologies, terminology, and criteria
that could be applied to characterize
and measure asbestos and other
potentially harmful elongate mineral
particles (EMPs) that may be present as
contaminants in such products. The
meeting included presentations by
members of an interagency working
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
information collection. https://
www.acl.gov/about-acl/public-input.
VerDate Sep<11>2014
16:34 Aug 18, 2020
Jkt 250001
I. Background
We opened a public docket and held
a public meeting on February 4, 2020,
to discuss and obtain scientific data and
information on topics related to
cosmetic products with talc as an
ingredient, specifically, testing
methodologies, terminology, and criteria
that could be applied to characterize
and measure asbestos and other
potentially harmful EMPs that may be
present as contaminants in such
products. The meeting included
presentations by members of an
interagency working group (IWGACP).
As part of the meeting materials, FDA
made available an Executive Summary
titled ‘‘Preliminary Recommendations
on Testing Methods for Asbestos in Talc
and Consumer Products Containing
Talc’’ by the IWGACP. Neither the
Executive Summary nor any of the
presentations at the public meeting by
members of the IWGACP represent
proposed or preliminary
recommendations or policies of FDA or
any other Federal Agency.
Recently, we have been made aware
of concerns that some external parties
may consider the Executive Summary to
be FDA recommendations. As a result,
we are announcing the availability of a
PO 00000
Frm 00029
Fmt 4703
Sfmt 9990
statement in the public docket to
address information provided in
connection with the public meeting. We
have also added corresponding content
on FDA’s web page for cosmetics and
talc (https://www.fda.gov/cosmetics/
cosmetic-ingredients/talc).
These updates are intended to clarify
that the Executive Summary and related
presentations at the public meeting were
meant solely to solicit scientific
feedback on the issues raised and
should not be used for any other
purpose. FDA and members of the
IWGACP continue to evaluate the
scientific literature and public feedback
to the docket. FDA does not have any
recommendations at this time. Should
FDA decide to develop
recommendations with respect to
standards or testing methods for
asbestos in talc, as a result of the
information it received as part of the
public meeting and comments to the
public docket or otherwise, it would
issue draft guidance for public
comment. Likewise, FDA would
propose any related regulations through
a public notice and comment process.
II. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
document at either https://www.fda.gov/
cosmetics/cosmetic-ingredients/talc or
https:/www.regulations.gov.
Dated: August 14, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–18181 Filed 8–18–20; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\19AUN1.SGM
19AUN1
]]>Agencies
[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Page 51035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18181]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0025]
Availability of FDA Statement Added to the Docket for Public
Meeting Related to Cosmetic Products Containing Talc
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a statement added to the docket for the public meeting
entitled ``Testing Methods for Asbestos in Talc and Cosmetic Products
Containing Talc'' to address information provided in connection with
the public meeting. FDA held the public meeting on February 4, 2020, to
discuss and obtain scientific data and information on topics related to
cosmetic products with talc as an ingredient, specifically, testing
methodologies, terminology, and criteria that could be applied to
characterize and measure asbestos and other potentially harmful
elongate mineral particles (EMPs) that may be present as contaminants
in such products. The meeting included presentations by members of an
interagency working group (the Interagency Working Group on Asbestos in
Consumer Products or IWGACP).
FOR FURTHER INFORMATION CONTACT: Deborah Smegal, Office of Cosmetics
and Colors, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Campus Dr., College Park, MD 20740, 240-402-1130.
SUPPLEMENTARY INFORMATION:
I. Background
We opened a public docket and held a public meeting on February 4,
2020, to discuss and obtain scientific data and information on topics
related to cosmetic products with talc as an ingredient, specifically,
testing methodologies, terminology, and criteria that could be applied
to characterize and measure asbestos and other potentially harmful EMPs
that may be present as contaminants in such products. The meeting
included presentations by members of an interagency working group
(IWGACP).
As part of the meeting materials, FDA made available an Executive
Summary titled ``Preliminary Recommendations on Testing Methods for
Asbestos in Talc and Consumer Products Containing Talc'' by the IWGACP.
Neither the Executive Summary nor any of the presentations at the
public meeting by members of the IWGACP represent proposed or
preliminary recommendations or policies of FDA or any other Federal
Agency.
Recently, we have been made aware of concerns that some external
parties may consider the Executive Summary to be FDA recommendations.
As a result, we are announcing the availability of a statement in the
public docket to address information provided in connection with the
public meeting. We have also added corresponding content on FDA's web
page for cosmetics and talc (https://www.fda.gov/cosmetics/cosmetic-ingredients/talc).
These updates are intended to clarify that the Executive Summary
and related presentations at the public meeting were meant solely to
solicit scientific feedback on the issues raised and should not be used
for any other purpose. FDA and members of the IWGACP continue to
evaluate the scientific literature and public feedback to the docket.
FDA does not have any recommendations at this time. Should FDA decide
to develop recommendations with respect to standards or testing methods
for asbestos in talc, as a result of the information it received as
part of the public meeting and comments to the public docket or
otherwise, it would issue draft guidance for public comment. Likewise,
FDA would propose any related regulations through a public notice and
comment process.
II. Electronic Access
Persons with access to the internet may obtain an electronic
version of the document at either https://www.fda.gov/cosmetics/cosmetic-ingredients/talc or https:/www.regulations.gov.
Dated: August 14, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-18181 Filed 8-18-20; 8:45 am]
BILLING CODE 4164-01-P
