National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments, 111-112 [2020-29079]
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111
Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices
Respondents to this collection of
information are manufacturers and
repackagers of male condoms made of
natural rubber latex without spermicidal
lubricant. FDA expects approximately
five new manufacturers or repackagers
to enter the market yearly and to
collectively have a third-party
disclosure burden of 60 hours. The
average burden per disclosure was
derived from a study performed for FDA
by Eastern Research Group, Inc., an
economic consulting firm, to estimate
the impact of the 1999 over-the-counter
(OTC) human drug labeling
requirements final rule (64 FR 13254,
March 17, 1999). Because the packaging
requirements for condoms are similar to
those of many OTC drugs, we believe
the burden to design the labeling for
OTC drugs is an appropriate proxy for
the estimated burden to design condom
labeling.
The special controls guidance
document also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 807, subpart E have been approved
under OMB control number 0910–0120;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
The collection of information under
21 CFR 801.437 does not constitute a
‘‘collection of information’’ under the
PRA. Rather, it 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)).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number of
respondents
Number of
disclosures per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
‘‘Class II Special Controls Guidance Document: Labeling
for Natural Rubber Latex Condoms Classified Under
21 CFR 884.5300’’ .........................................................
5
1
5
12
60
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–29091 Filed 12–31–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program Board of
Scientific Counselors; Announcement
of Meeting; Request for Comments
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This notice announces the
next meeting of the National Toxicology
Program (NTP) Board of Scientific
Counselors (BSC). The BSC, a federally
chartered, external advisory group
composed of scientists from the public
and private sectors, will review and
provide advice on programmatic
activities. This meeting is a virtual
meeting and is open to the public.
Written comments will be accepted and
registration is required to present oral
comments. Information about the
meeting and registration is available at
https://ntp.niehs.nih.gov/go/165.
DATES:
SUMMARY:
VerDate Sep<11>2014
17:28 Dec 31, 2020
Jkt 253001
Meeting: Scheduled for February 2,
2021, 12:30 p.m.–5:00 p.m. Eastern
Standard Time (EST). Written Public
Comment Submissions: Deadline is
January 26, 2021.
Registration for Oral Comments:
Deadline is January 26, 2021.
ADDRESSES:
Meeting Web page: The preliminary
agenda, registration, and other meeting
materials are available at https://
ntp.niehs.nih.gov/go/165.
Virtual Meeting: The URL for viewing
the virtual meeting will be provided on
the meeting web page.
FOR FURTHER INFORMATION CONTACT: Dr.
Sheena Scruggs, Designated Federal
Official for the BSC, Office of Liaison,
Policy and Review, Division of NTP,
NIEHS, P.O. Box 12233, K2–03,
Research Triangle Park, NC 27709.
Phone: 984–287–3355, Fax: 301–451–
5759, Email: sheena.scruggs@nih.gov.
Hand Deliver/Courier address: 530
Davis Drive, Room K2130, Morrisville,
NC 27560.
SUPPLEMENTARY INFORMATION: The BSC
will provide input to the NTP on
programmatic activities and issues. The
preliminary agenda topics include
presentations from two of the Division
of the National Toxicology Program
(DNTP)’s research program areas. The
preliminary agenda, roster of BSC
members, background materials, public
comments, and any additional
information, when available, will be
posted on the BSC meeting web page
(https://ntp.niehs.nih.gov/go/165) or
may be requested in hardcopy from the
PO 00000
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Designated Federal Official for the BSC.
Following the meeting, summary
minutes will be prepared and made
available on the BSC meeting web page.
Meeting Attendance Registration: The
meeting is open to the public with time
scheduled for oral public comments.
Registration is not required to view the
virtual meeting; the URL for the virtual
meeting is provided on the BSC meeting
web page (https://ntp.niehs.nih.gov/go/
165). TTY users should contact the
Federal TTY Relay Service at 800–877–
8339. Requests should be made at least
five business days in advance of the
event.
Written Public Comments: NTP
invites written public comments.
Guidelines for public comments are
available at https://ntp.niehs.nih.gov/
ntp/about_ntp/guidelines_public_
comments_508.pdf.
The deadline for submission of
written comments is January 26, 2021.
Written public comments should be
submitted through the meeting web
page. Persons submitting written
comments should include name,
affiliation, mailing address, phone,
email, and sponsoring organization (if
any). Written comments received in
response to this notice will be posted on
the NTP web page, and the submitter
will be identified by name, affiliation,
and sponsoring organization (if any).
Oral Public Comment Registration:
The agenda allows for two formal public
comment periods—one comment period
for each program area (up to 3
commenters, up to 5 minutes per
speaker, per topic). Persons wishing to
E:\FR\FM\04JAN1.SGM
04JAN1
112
Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices
make an oral comment are required to
register online at https://
ntp.niehs.nih.gov/go/165 by January 26,
2021. Oral comments will be received
only during the formal comment periods
indicated on the preliminary agenda.
Oral comments will only be by
teleconference line. The access number
for the teleconference line will be
provided to registrants by email prior to
the meeting. Registration is on a firstcome, first-served basis. Each
organization is allowed one time slot
per topic. After the maximum number of
speakers per comment period is
exceeded, individuals registered to
provide oral comment will be placed on
a wait list and notified should an
opening become available. Commenters
will be notified approximately one week
before the meeting about the actual time
allotted per speaker.
If possible, oral public commenters
should send a copy of their slides and/
or statement or talking points to NTPMeetings@icf.com by January 26, 2021.
Meeting Materials: The preliminary
meeting agenda is available on the
meeting web page (https://
ntp.niehs.nih.gov/go/165) and will be
updated one week before the meeting.
Individuals are encouraged to access the
meeting web page to stay abreast of the
most current information regarding the
meeting.
Background Information on the BSC:
The BSC is a technical advisory body
comprised of scientists from the public
and private sectors that provides
primary scientific oversight to the NTP.
Specifically, the BSC advises the NTP
on matters of scientific program content,
both present and future, and conducts
periodic review of the program for the
purpose of determining and advising on
the scientific merit of its activities and
their overall scientific quality. Its
members are selected from recognized
authorities knowledgeable in fields such
as toxicology, pharmacology, pathology,
epidemiology, risk assessment,
carcinogenesis, mutagenesis, cellular
biology, computational toxicology,
neurotoxicology, genetic toxicology,
reproductive toxicology or teratology,
and biostatistics. Members serve
overlapping terms of up to four years.
The BSC usually meets periodically.
The authority for the BSC is provided by
42 U.S.C. 217a, section 222 of the Public
Health Service Act (PHS), as amended.
The BSC is governed by the
provisions of the Federal Advisory
Committee Act, as amended (5 U.S.C.
app.), which sets forth standards for the
formation and use of advisory
committees.
VerDate Sep<11>2014
17:28 Dec 31, 2020
Jkt 253001
Dated: December 29, 2020.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2020–29079 Filed 12–31–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine and Oral
Fluid Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITFs) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs using Urine or Oral Fluid
(Mandatory Guidelines).
FOR FURTHER INFORMATION CONTACT:
Anastasia Donovan, Division of
Workplace Programs, SAMHSA/CSAP,
5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240–276–
2600 (voice); Anastasia.Donovan@
samhsa.hhs.gov (email).
SUPPLEMENTARY INFORMATION: A notice
listing all currently HHS-certified
laboratories and IITFs is published in
the Federal Register during the first
week of each month. If any laboratory or
IITF certification is suspended or
revoked, the laboratory or IITF will be
omitted from subsequent lists until such
time as it is restored to full certification
under the Mandatory Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
at the end and will be omitted from the
monthly listing thereafter.
This notice is also available on the
internet at https://www.samhsa.gov/
workplace/resources/drug-testing/
certified-lab-list.
The Department of Health and Human
Services (HHS) notifies federal agencies
of the laboratories and Instrumented
Initial Testing Facilities (IITFs)
currently certified to meet the standards
of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Mandatory Guidelines) using Urine and
SUMMARY:
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of the laboratories currently certified to
meet the standards of the Mandatory
Guidelines using Oral Fluid.
The Mandatory Guidelines using
Urine were first published in the
Federal Register on April 11, 1988 (53
FR 11970), and subsequently revised in
the Federal Register on June 9, 1994 (59
FR 29908); September 30, 1997 (62 FR
51118); April 13, 2004 (69 FR 19644);
November 25, 2008 (73 FR 71858);
December 10, 2008 (73 FR 75122); April
30, 2010 (75 FR 22809); and on January
23, 2017 (82 FR 7920).
The Mandatory Guidelines using Oral
Fluid were first published in the
Federal Register on October 25, 2019
(84 FR 57554) with an effective date of
January 1, 2020.
The Mandatory Guidelines were
initially developed in accordance with
Executive Order 12564 and section 503
of Public Law 100–71 and allowed urine
drug testing only. The Mandatory
Guidelines using Urine have since been
revised, and new Mandatory Guidelines
allowing for oral fluid drug testing have
been published. The Mandatory
Guidelines require strict standards that
laboratories and IITFs must meet in
order to conduct drug and specimen
validity tests on specimens for federal
agencies. HHS does not allow IITFs to
conduct oral fluid testing.
To become certified, an applicant
laboratory or IITF must undergo three
rounds of performance testing plus an
on-site inspection. To maintain that
certification, a laboratory or IITF must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories and IITFs in the
applicant stage of certification are not to
be considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines using Urine and/
or Oral Fluid. An HHS-certified
laboratory or IITF must have its letter of
certification from HHS/SAMHSA
(formerly: HHS/NIDA), which attests
that the test facility has met minimum
standards. HHS does not allow IITFs to
conduct oral fluid testing.
HHS-Certified Laboratories Approved
To Conduct Oral Fluid Drug Testing
In accordance with the Mandatory
Guidelines using Oral Fluid dated
October 25, 2019 (84 FR 57554), the
following HHS-certified laboratories
meet the minimum standards to conduct
drug and specimen validity tests on oral
fluid specimens:
At this time, there are no laboratories
certified to conduct drug and specimen
validity tests on oral fluid specimens.
E:\FR\FM\04JAN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 111-112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29079]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program Board of Scientific Counselors;
Announcement of Meeting; Request for Comments
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the next meeting of the National
Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC,
a federally chartered, external advisory group composed of scientists
from the public and private sectors, will review and provide advice on
programmatic activities. This meeting is a virtual meeting and is open
to the public. Written comments will be accepted and registration is
required to present oral comments. Information about the meeting and
registration is available at https://ntp.niehs.nih.gov/go/165.
DATES:
Meeting: Scheduled for February 2, 2021, 12:30 p.m.-5:00 p.m.
Eastern Standard Time (EST). Written Public Comment Submissions:
Deadline is January 26, 2021.
Registration for Oral Comments: Deadline is January 26, 2021.
ADDRESSES:
Meeting Web page: The preliminary agenda, registration, and other
meeting materials are available at https://ntp.niehs.nih.gov/go/165.
Virtual Meeting: The URL for viewing the virtual meeting will be
provided on the meeting web page.
FOR FURTHER INFORMATION CONTACT: Dr. Sheena Scruggs, Designated Federal
Official for the BSC, Office of Liaison, Policy and Review, Division of
NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709.
Phone: 984-287-3355, Fax: 301-451-5759, Email: [email protected].
Hand Deliver/Courier address: 530 Davis Drive, Room K2130, Morrisville,
NC 27560.
SUPPLEMENTARY INFORMATION: The BSC will provide input to the NTP on
programmatic activities and issues. The preliminary agenda topics
include presentations from two of the Division of the National
Toxicology Program (DNTP)'s research program areas. The preliminary
agenda, roster of BSC members, background materials, public comments,
and any additional information, when available, will be posted on the
BSC meeting web page (https://ntp.niehs.nih.gov/go/165) or may be
requested in hardcopy from the Designated Federal Official for the BSC.
Following the meeting, summary minutes will be prepared and made
available on the BSC meeting web page.
Meeting Attendance Registration: The meeting is open to the public
with time scheduled for oral public comments. Registration is not
required to view the virtual meeting; the URL for the virtual meeting
is provided on the BSC meeting web page (https://ntp.niehs.nih.gov/go/165). TTY users should contact the Federal TTY Relay Service at 800-
877-8339. Requests should be made at least five business days in
advance of the event.
Written Public Comments: NTP invites written public comments.
Guidelines for public comments are available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
The deadline for submission of written comments is January 26,
2021. Written public comments should be submitted through the meeting
web page. Persons submitting written comments should include name,
affiliation, mailing address, phone, email, and sponsoring organization
(if any). Written comments received in response to this notice will be
posted on the NTP web page, and the submitter will be identified by
name, affiliation, and sponsoring organization (if any).
Oral Public Comment Registration: The agenda allows for two formal
public comment periods--one comment period for each program area (up to
3 commenters, up to 5 minutes per speaker, per topic). Persons wishing
to
[[Page 112]]
make an oral comment are required to register online at https://ntp.niehs.nih.gov/go/165 by January 26, 2021. Oral comments will be
received only during the formal comment periods indicated on the
preliminary agenda. Oral comments will only be by teleconference line.
The access number for the teleconference line will be provided to
registrants by email prior to the meeting. Registration is on a first-
come, first-served basis. Each organization is allowed one time slot
per topic. After the maximum number of speakers per comment period is
exceeded, individuals registered to provide oral comment will be placed
on a wait list and notified should an opening become available.
Commenters will be notified approximately one week before the meeting
about the actual time allotted per speaker.
If possible, oral public commenters should send a copy of their
slides and/or statement or talking points to [email protected] by
January 26, 2021.
Meeting Materials: The preliminary meeting agenda is available on
the meeting web page (https://ntp.niehs.nih.gov/go/165) and will be
updated one week before the meeting. Individuals are encouraged to
access the meeting web page to stay abreast of the most current
information regarding the meeting.
Background Information on the BSC: The BSC is a technical advisory
body comprised of scientists from the public and private sectors that
provides primary scientific oversight to the NTP. Specifically, the BSC
advises the NTP on matters of scientific program content, both present
and future, and conducts periodic review of the program for the purpose
of determining and advising on the scientific merit of its activities
and their overall scientific quality. Its members are selected from
recognized authorities knowledgeable in fields such as toxicology,
pharmacology, pathology, epidemiology, risk assessment, carcinogenesis,
mutagenesis, cellular biology, computational toxicology,
neurotoxicology, genetic toxicology, reproductive toxicology or
teratology, and biostatistics. Members serve overlapping terms of up to
four years. The BSC usually meets periodically. The authority for the
BSC is provided by 42 U.S.C. 217a, section 222 of the Public Health
Service Act (PHS), as amended.
The BSC is governed by the provisions of the Federal Advisory
Committee Act, as amended (5 U.S.C. app.), which sets forth standards
for the formation and use of advisory committees.
Dated: December 29, 2020.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2020-29079 Filed 12-31-20; 8:45 am]
BILLING CODE 4140-01-P
