World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC or Advisory Committee), National Institute for Occupational Safety and Health (NIOSH), 71504-71505 [2016-25039]
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Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
Approved: October 12, 2016.
Walter M. Shaub, Jr.,
Director, Office of Government Ethics.
[FR Doc. 2016–25053 Filed 10–14–16; 8:45 am]
BILLING CODE 6345–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number CDC–2016–0093; NIOSH
248–F]
jstallworth on DSK7TPTVN1PROD with NOTICES
World Trade Center Health Program
Scientific/Technical Advisory
Committee (WTCHP STAC or Advisory
Committee), National Institute for
Occupational Safety and Health
(NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Time and Date: 9:00 a.m.–5:00 p.m.,
November 3, 2016 (All times are Eastern
Daylight Time).
Place: Jacob J. Javits Federal Building,
26 Federal Plaza, New York, New York
10278. This meeting is also available by
telephone and Web conference. Audio
will be available by telephone only;
visuals will be available by Web
conference. The USA toll-free, dial-in
number is 1–888–810–4931, and when
prompted enter passcode—8328289. To
view the web conference, enter the
following web address in your web
browser: https://
odniosh.adobeconnect.com/wtchpstac/.
Public Comment Time and Date:
10:45 a.m.–11:15 a.m. (Eastern Daylight
Time), November 3, 2016.
Please note that the public comment
period ends at the time indicated above
or following the last call for comments,
whichever is earlier. Members of the
public who want to comment must sign
up by providing their name by mail,
email, or telephone, at the addresses
provided below by October 31, 2016.
Each commenter will be provided up to
five minutes for comment. A limited
number of time slots are available and
will be assigned on a first come—first
served basis. Written comments will
also be accepted from those unable to
attend the public session.
Status: Open to the public, limited
only by the number of telephone lines.
The conference line will accommodate
up to 50 callers. The room will
accommodate approximately 100
persons.
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Background: The Advisory Committee
was established by Title I of the James
Zadroga 9/11 Health and Compensation
Act of 2010, Public Law 111–347
(January 2, 2011), amended by Public
Law 114–113 (Dec. 18, 2015), adding
Title XXXIII to the Public Health
Service Act (codified at 42 U.S.C.
300mm to 300mm–61).
Purpose: The purpose of the Advisory
Committee is to review scientific and
medical evidence and to make
recommendations to the World Trade
Center (WTC) Program Administrator
regarding additional WTC Health
Program eligibility criteria, potential
additions to the list of covered WTCrelated health conditions, and research
regarding certain health conditions
related to the September 11, 2001
terrorist attacks.
Title XXXIII of the PHS Act
established the WTC Health Program
within the Department of Health and
Human Services (HHS). The WTC
Health Program provides medical
monitoring and treatment benefits to
eligible firefighters and related
personnel, law enforcement officers,
and rescue, recovery, and cleanup
workers who responded to the
September 11, 2001, terrorist attacks in
New York City, at the Pentagon, and in
Shanksville, Pennsylvania (responders),
and to eligible persons who were
present in the dust or dust cloud on
September 11, 2001 or who worked,
resided, or attended school, childcare,
or adult daycare in the New York City
disaster area (survivors). Certain specific
activities of the WTC Program
Administrator are reserved to the
Secretary, HHS, to delegate at her
discretion; other WTC Program
Administrator duties not explicitly
reserved to the Secretary, HHS, are
assigned to the Director, NIOSH. The
administration of the Advisory
Committee is left to the Director of
NIOSH in his role as WTC Program
Administrator. CDC and NIOSH provide
funding, staffing, and administrative
support services for the Advisory
Committee. The charter was reissued on
May 12, 2015, and will expire on May
12, 2017.
Matters for Discussion: The Advisory
Committee will address the new
responsibilities required under the
reauthorization of the WTC Health
Program in the PHS Act. Specifically,
the enhanced role of the STAC to: (1)
Make recommendations regarding the
identification of individuals to conduct
independent peer reviews of the
evidence that would be the basis for
issuing final rules to add a health
condition to the List of WTC-Related
Health Conditions; and (2) review and
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evaluate the policies and procedures in
effect within the WTC Health Program
that are used to determine whether
sufficient evidence is available to
support adding a non-cancer condition
or type of cancer to the List of WTCRelated Health Conditions.
The two policies can be found at:
https://www.cdc.gov/wtc/policies.html.
The agenda will include workgroup
presentations on independent peer
review and the policies and procedures
the WTC Health Program uses to add
health conditions to the list of covered
conditions.
The agenda is subject to change as
priorities dictate.
To view the notice, visit https://
www.regulations.gov and enter CDC–
2016–0093 in the search field and click
‘‘Search.’’
Public Comment Sign-up and
Submissions to the Docket: To sign up
to provide public comments or to
submit comments to the docket, send
information to the NIOSH Docket Office
by one of the following means:
Mail: NIOSH Docket Office, Robert A.
Taft Laboratories, MS C–34, 1090
Tusculum Avenue, Cincinnati, Ohio
45226.
Email: nioshdocket@cdc.gov.
Telephone: (513) 533–8611.
In the event an individual cannot
attend, written comments may be
submitted. The comments should be
limited to two pages and submitted
through https://www.regulations.gov by
October 31, 2016. Efforts will be made
to provide the two-page written
comments received by the deadline
above to the committee members before
the meeting. Comments in excess of two
pages will be made publicly available at
https://www.regulations.gov.
Policy on Redaction of Committee
Meeting Transcripts (Public Comment):
Transcripts will be prepared and posted
to https://www.regulations.gov within 60
days after the meeting. If a person
making a comment gives his or her
name, no attempt will be made to redact
that name. NIOSH will take reasonable
steps to ensure that individuals making
public comments are aware of the fact
that their comments (including their
name, if provided) will appear in a
transcript of the meeting posted on a
public Web site. Such reasonable steps
include a statement read at the start of
the meeting stating that transcripts will
be posted and names of speakers will
not be redacted. If individuals in
making a statement reveal personal
information (e.g., medical information)
about themselves, that information will
not usually be redacted. The CDC
Freedom of Information Act coordinator
will, however, review such revelations
E:\FR\FM\17OCN1.SGM
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Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
in accordance with the Freedom of
Information Act and, if deemed
appropriate, will redact such
information. Disclosures of information
concerning third party medical
information will be redacted.
Contact person for more information:
Paul J. Middendorf, Ph.D., Designated
Federal Officer, NIOSH, CDC, 2400
Century Parkway NE., Mail Stop E–20,
Atlanta, Georgia 30345, telephone 1
(888) 982–4748; email: wtc-stac@
cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, Washington, DC 20503 or by fax
to (202) 395–5806. Written comments
should be received within 30 days of
this notice.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Proposed Project
Study to Explore Early Development
(SEED) Phase 3—New—National Center
on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
[FR Doc. 2016–25039 Filed 10–14–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–16PA]
jstallworth on DSK7TPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
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Background and Brief Description
Autism spectrum disorders (ASD) are
a group of neurodevelopmental
disorders characterized by qualitative
impairments in social interaction and
communication and stereotyped
behaviors and interests. Recent
systematic population surveys and
routine monitoring systems in the U.S.
and other countries indicate the
prevalence to be 1–2%. Apart from the
identification of some rare genetic
conditions that are commonly
associated with autism, causal
mechanisms for the disorder largely
remain unknown.
The Children’s Health Act of 2000
mandated CDC to establish autism
surveillance and research programs to
address the number, incidence, and
causes of autism and related
developmental disabilities. Under the
provisions of this act, NCBDDD funded
five Centers for Autism and
Developmental Disabilities Research
and Epidemiology (CADDRE) through
program announcements in FY2001 and
FY2002; CDC’s NCBDDD served as the
sixth CADDRE site.
For the first funding cycle (2001–
2006), each CADDRE grantee had three
core objectives: To develop a protocol
for a multi-site collaborative
epidemiologic study focused on autism
(which was eventually named the Study
to Explore Early Development [SEED]);
to conduct surveillance of autism and
other developmental disabilities; and to
conduct site-specific investigator-
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initiated studies on autism. In FY 2006,
through a second CADDRE funding
cycle, five grantees were awarded. The
CADDRE activities for the second
funding cycle (2006–2011) were limited
to implementation of the first phase of
SEED (subsequently known as SEED 1).
CDC served as the sixth CADDRE SEED
1 site during this period. A second
phase of SEED (SEED 2) was funded
under a third funding cycle (2011–
2016). Five CADDRE grantees received
the awards. Again, CDC served as the
sixth SEED 2 site.
A third phase of SEED (SEED 3) was
funded in July 2016. Five extramural
sites were funded. Together with the
CDC, they will implement the SEED 3
collaborative protocol. The SEED 3
protocol for identification of study
participants, recruitment, and study
data collection flow will be similar to
the protocols for SEED 1 and 2.
However, while all SEED phases have
the same research goals and the same
basic study design, data collection has
been greatly streamlined and revised
between SEED 1, SEED 2, and SEED 3.
Many study instruments and data
collection components included in the
SEED 1 protocol are not included in the
SEED 3 protocol; two instruments
included in the SEED 3 protocol were
developed subsequent to SEED 1 to
capture an abbreviated version of
information that had been included on
some of the discontinued SEED 1 forms
and to capture some additional
information overlooked in the SEED 1
protocol; and instruments included in
all phases of SEED underwent review
and minor revision subsequent to SEED
1 to address ambiguities and difficulties
experienced during SEED 1 data
collection. Implementing this phase of
SEED will increase the total SEED
pooled sample size for investigation of
high priority hypotheses. Maintaining
the same basic study design and general
protocol integrity will ensure that data
pooling can be achieved across SEED
phases.
Families will be identified from each
of the 3 groups: Autism Spectrum
Disorder (ASD), other developmental
delay or disorder comparison group
(DD), and a second comparison group of
children randomly drawn from the
entire study cohort population (POP). It
is expected that the 6 SEED 3 study sites
will have a total of 2,106 children enroll
and complete the study protocol. The
data collection process will take
approximately 9 hours 10 minutes (ASD
group); 5 hours 30 minutes (POP group);
2 hours 45 minutes (DD group) to
complete, which includes (1) maternal
telephone interview with questions
about maternal reproductive history and
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]]>Agencies
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71504-71505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25039]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number CDC-2016-0093; NIOSH 248-F]
World Trade Center Health Program Scientific/Technical Advisory
Committee (WTCHP STAC or Advisory Committee), National Institute for
Occupational Safety and Health (NIOSH)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC), announces the following meeting of the aforementioned
committee:
Time and Date: 9:00 a.m.-5:00 p.m., November 3, 2016 (All times are
Eastern Daylight Time).
Place: Jacob J. Javits Federal Building, 26 Federal Plaza, New
York, New York 10278. This meeting is also available by telephone and
Web conference. Audio will be available by telephone only; visuals will
be available by Web conference. The USA toll-free, dial-in number is 1-
888-810-4931, and when prompted enter passcode--8328289. To view the
web conference, enter the following web address in your web browser:
https://odniosh.adobeconnect.com/wtchpstac/.
Public Comment Time and Date: 10:45 a.m.-11:15 a.m. (Eastern
Daylight Time), November 3, 2016.
Please note that the public comment period ends at the time
indicated above or following the last call for comments, whichever is
earlier. Members of the public who want to comment must sign up by
providing their name by mail, email, or telephone, at the addresses
provided below by October 31, 2016. Each commenter will be provided up
to five minutes for comment. A limited number of time slots are
available and will be assigned on a first come--first served basis.
Written comments will also be accepted from those unable to attend the
public session.
Status: Open to the public, limited only by the number of telephone
lines. The conference line will accommodate up to 50 callers. The room
will accommodate approximately 100 persons.
Background: The Advisory Committee was established by Title I of
the James Zadroga 9/11 Health and Compensation Act of 2010, Public Law
111-347 (January 2, 2011), amended by Public Law 114-113 (Dec. 18,
2015), adding Title XXXIII to the Public Health Service Act (codified
at 42 U.S.C. 300mm to 300mm-61).
Purpose: The purpose of the Advisory Committee is to review
scientific and medical evidence and to make recommendations to the
World Trade Center (WTC) Program Administrator regarding additional WTC
Health Program eligibility criteria, potential additions to the list of
covered WTC-related health conditions, and research regarding certain
health conditions related to the September 11, 2001 terrorist attacks.
Title XXXIII of the PHS Act established the WTC Health Program
within the Department of Health and Human Services (HHS). The WTC
Health Program provides medical monitoring and treatment benefits to
eligible firefighters and related personnel, law enforcement officers,
and rescue, recovery, and cleanup workers who responded to the
September 11, 2001, terrorist attacks in New York City, at the
Pentagon, and in Shanksville, Pennsylvania (responders), and to
eligible persons who were present in the dust or dust cloud on
September 11, 2001 or who worked, resided, or attended school,
childcare, or adult daycare in the New York City disaster area
(survivors). Certain specific activities of the WTC Program
Administrator are reserved to the Secretary, HHS, to delegate at her
discretion; other WTC Program Administrator duties not explicitly
reserved to the Secretary, HHS, are assigned to the Director, NIOSH.
The administration of the Advisory Committee is left to the Director of
NIOSH in his role as WTC Program Administrator. CDC and NIOSH provide
funding, staffing, and administrative support services for the Advisory
Committee. The charter was reissued on May 12, 2015, and will expire on
May 12, 2017.
Matters for Discussion: The Advisory Committee will address the new
responsibilities required under the reauthorization of the WTC Health
Program in the PHS Act. Specifically, the enhanced role of the STAC to:
(1) Make recommendations regarding the identification of individuals to
conduct independent peer reviews of the evidence that would be the
basis for issuing final rules to add a health condition to the List of
WTC-Related Health Conditions; and (2) review and evaluate the policies
and procedures in effect within the WTC Health Program that are used to
determine whether sufficient evidence is available to support adding a
non-cancer condition or type of cancer to the List of WTC-Related
Health Conditions.
The two policies can be found at: https://www.cdc.gov/wtc/policies.html.
The agenda will include workgroup presentations on independent peer
review and the policies and procedures the WTC Health Program uses to
add health conditions to the list of covered conditions.
The agenda is subject to change as priorities dictate.
To view the notice, visit https://www.regulations.gov and enter CDC-
2016-0093 in the search field and click ``Search.''
Public Comment Sign-up and Submissions to the Docket: To sign up to
provide public comments or to submit comments to the docket, send
information to the NIOSH Docket Office by one of the following means:
Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS C-34,
1090 Tusculum Avenue, Cincinnati, Ohio 45226.
Email: nioshdocket@cdc.gov.
Telephone: (513) 533-8611.
In the event an individual cannot attend, written comments may be
submitted. The comments should be limited to two pages and submitted
through https://www.regulations.gov by October 31, 2016. Efforts will be
made to provide the two-page written comments received by the deadline
above to the committee members before the meeting. Comments in excess
of two pages will be made publicly available at https://www.regulations.gov.
Policy on Redaction of Committee Meeting Transcripts (Public
Comment): Transcripts will be prepared and posted to https://www.regulations.gov within 60 days after the meeting. If a person
making a comment gives his or her name, no attempt will be made to
redact that name. NIOSH will take reasonable steps to ensure that
individuals making public comments are aware of the fact that their
comments (including their name, if provided) will appear in a
transcript of the meeting posted on a public Web site. Such reasonable
steps include a statement read at the start of the meeting stating that
transcripts will be posted and names of speakers will not be redacted.
If individuals in making a statement reveal personal information (e.g.,
medical information) about themselves, that information will not
usually be redacted. The CDC Freedom of Information Act coordinator
will, however, review such revelations
[[Page 71505]]
in accordance with the Freedom of Information Act and, if deemed
appropriate, will redact such information. Disclosures of information
concerning third party medical information will be redacted.
Contact person for more information: Paul J. Middendorf, Ph.D.,
Designated Federal Officer, NIOSH, CDC, 2400 Century Parkway NE., Mail
Stop E-20, Atlanta, Georgia 30345, telephone 1 (888) 982-4748; email:
wtc-stac@cdc.gov.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention, and the Agency
for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2016-25039 Filed 10-14-16; 8:45 am]
BILLING CODE 4163-18-P
