National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting, 1320 [2020-00192]
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Federal Register / Vol. 85, No. 7 / Friday, January 10, 2020 / Notices
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2. Testing laboratories should report
all EMPs having length ≥0.5
micrometers (500 nanometers (nm)).
3. Test methods should specify
reportable EMPs identified as
amphibole or chrysotile particles as
covered minerals.
4. Test methods should include the
counting and reporting of covered EMPs
as a function of sample mass. In
counting, guidelines such as ISO 10312,
‘‘Ambient air—Determination of
asbestos fibres—Direct transfer
transmission electronic microscopy
method’’ (Ref. 6), classify primary and
secondary structures. Individual fibers
in secondary structures can be counted
recording the dimensions of each fiber.
5. Use of TEM at nominally 20,000 ×
magnification, in addition to PLM, to
resolve the issues of sensitivity that
cause reporting of false negatives for
covered EMPs. Use of TEM with energy
dispersive x ray spectroscopy and
selected area electron diffraction
analyses may reliably detect and
identify chrysotile and asbestiform and
non-asbestiform amphibole minerals,
including EMPs whose narrowest width
is <200 nm. Scanning electron
microscopy might be useful as a
complementary method, but has
significant shortcomings for
identification of chrysotile and
visualization of the narrowest particles
in the population that can only be
overcome by using TEM.
6. ‘‘Mass percent’’, a unit that is
frequently used to express content of
asbestos in commercial bulk materials,
is not appropriate for measurement of
EMPs in talc and consumer products
containing talc because mass percent
does not correlate with the number of
fibers, and one large fiber could
dominate the mass percent value.
V. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they also are available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
1. The Cosmetic, Toiletry and Fragrance
VerDate Sep<11>2014
16:39 Jan 09, 2020
Jkt 250001
Association, Inc. (CTFA) 1990. Method,
J 4–1, ‘‘Asbestiform Amphibole Minerals
in Cosmetic Talc’’ in Compendium of
Cosmetic Ingredient Composition:
Specifications Personal Care Products
Council, Washington DC (1976) (revised
in 1990). See https://
www.asbestosandtalc.com/EMP%20
Detection%20Limits%20ASTM/
PCPC000960.pdf.
2. USP, Revision Bulletin, ‘‘Talc,’’ dated
August 1, 2011, at page 2. See https://
www.usp.org/sites/default/files/usp/
document/harmonization/excipients/
m80360talc.pdf.
*3. Woodcock, J. (2010). Letter to Roger L.
Williams, CEO of USP (October 12,
2010). See https://www.usp.org/sites/
default/files/usp/document/get-involved/
monograph-modernization/2010-10-12letter-from-dr-janet-woodcock.pdf.
4. Block L.H., D. Beckers, J. Ferret, G.P.
Meeker, et al. (2014). ‘‘Stimuli to the
Revision Process, Modernization of
Asbestos Testing in USP Talc,’’ USP–PF
40(4).
*5. NIOSH 2011. ‘‘Asbestos Fibers and Other
Elongate Mineral Particles: State of the
Science and Roadmap for Research,’’
Current Intelligence Bulletin 62.
Department of Health and Human
Services. Centers for Disease Control and
Prevention. National Institute for
Occupational Safety and Health.
Publication No. 2011–159 (March 2011).
https://www.cdc.gov/niosh/docs/2011159/pdfs/2011-159.pdf.
6. International Organization for
Standardization, ‘‘ISO 10312:2019(en)
Ambient air—Determination of asbestos
fibres—Direct transfer transmission
electron microscopy method.’’ See
https://www.iso.org/obp/ui/
#iso:std:iso:10312:ed-2:v1:en.
Dated: January 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00259 Filed 1–9–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Arthritis and
Musculoskeletal and Skin Diseases
Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
PO 00000
Frm 00023
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notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Advisory Council.
Date: February 4, 2020.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: To review program documents
and policies.
Place: Porter Neuroscience Research
Center, Building 35A, Room: 620/630, 35
Convent Drive, Bethesda, MD 20892.
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Porter Neuroscience Research
Center, Building 35A, Room: 620/630, 35
Convent Drive, Bethesda, MD 20892.
Contact Person: Melinda Nelson, Acting
Director, Grants Management Branch,
National Institute of Arthritis and
Musculoskeletal and Skin Diseases, 45 Center
Drive, Natcher Building, Room 5A49,
Bethesda, MD 20892, (301) 594–3535,
mn23z@nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: January 6, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–00192 Filed 1–9–20; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 85, Number 7 (Friday, January 10, 2020)]
[Notices]
[Page 1320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00192]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin
Diseases; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Arthritis
and Musculoskeletal and Skin Diseases Advisory Council.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Arthritis and
Musculoskeletal and Skin Diseases Advisory Council.
Date: February 4, 2020.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: To review program documents and policies.
Place: Porter Neuroscience Research Center, Building 35A, Room:
620/630, 35 Convent Drive, Bethesda, MD 20892.
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Porter Neuroscience Research Center, Building 35A, Room:
620/630, 35 Convent Drive, Bethesda, MD 20892.
Contact Person: Melinda Nelson, Acting Director, Grants
Management Branch, National Institute of Arthritis and
Musculoskeletal and Skin Diseases, 45 Center Drive, Natcher
Building, Room 5A49, Bethesda, MD 20892, (301) 594-3535,
[email protected].
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
driver's license, or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance Program Nos. 93.846,
Arthritis, Musculoskeletal and Skin Diseases Research, National
Institutes of Health, HHS)
Dated: January 6, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-00192 Filed 1-9-20; 8:45 am]
BILLING CODE 4140-01-P
