81 FR 71504 - World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC or Advisory Committee), National Institute for Occupational Safety and Health (NIOSH)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 200 (October 17, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 200 (October 17, 2016)
| Page Range | 71504-71505 | |
| FR Document | 2016-25039 |
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)] [Notices] [Pages 71504-71505] From the Federal Register Online [www.thefederalregister.org] [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: http://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 http://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: ni[email protected]. 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 http://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 http://www.regulations.gov. Policy on Redaction of Committee Meeting Transcripts (Public Comment): Transcripts will be prepared and posted to http://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: [email protected]. 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
![71504 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
Approved: October 12, 2016. Background: The Advisory Committee evaluate the policies and procedures in
Walter M. Shaub, Jr., was established by Title I of the James effect within the WTC Health Program
Director, Office of Government Ethics. Zadroga 9/11 Health and Compensation that are used to determine whether
[FR Doc. 2016–25053 Filed 10–14–16; 8:45 am] Act of 2010, Public Law 111–347 sufficient evidence is available to
BILLING CODE 6345–03–P
(January 2, 2011), amended by Public support adding a non-cancer condition
Law 114–113 (Dec. 18, 2015), adding or type of cancer to the List of WTC-
Title XXXIII to the Public Health Related Health Conditions.
Service Act (codified at 42 U.S.C. The two policies can be found at:
DEPARTMENT OF HEALTH AND 300mm to 300mm–61). http://www.cdc.gov/wtc/policies.html.
HUMAN SERVICES Purpose: The purpose of the Advisory The agenda will include workgroup
Committee is to review scientific and presentations on independent peer
Centers for Disease Control and
medical evidence and to make review and the policies and procedures
Prevention
recommendations to the World Trade the WTC Health Program uses to add
[Docket Number CDC–2016–0093; NIOSH Center (WTC) Program Administrator health conditions to the list of covered
248–F] regarding additional WTC Health conditions.
Program eligibility criteria, potential The agenda is subject to change as
World Trade Center Health Program additions to the list of covered WTC- priorities dictate.
Scientific/Technical Advisory related health conditions, and research To view the notice, visit http://
Committee (WTCHP STAC or Advisory regarding certain health conditions www.regulations.gov and enter CDC–
Committee), National Institute for related to the September 11, 2001 2016–0093 in the search field and click
Occupational Safety and Health terrorist attacks. ‘‘Search.’’
(NIOSH) Title XXXIII of the PHS Act Public Comment Sign-up and
established the WTC Health Program Submissions to the Docket: To sign up
In accordance with section 10(a)(2) of within the Department of Health and to provide public comments or to
the Federal Advisory Committee Act Human Services (HHS). The WTC submit comments to the docket, send
(Pub. L. 92–463), the Centers for Disease Health Program provides medical information to the NIOSH Docket Office
Control and Prevention (CDC), monitoring and treatment benefits to by one of the following means:
announces the following meeting of the eligible firefighters and related Mail: NIOSH Docket Office, Robert A.
aforementioned committee: personnel, law enforcement officers, Taft Laboratories, MS C–34, 1090
Time and Date: 9:00 a.m.–5:00 p.m., and rescue, recovery, and cleanup Tusculum Avenue, Cincinnati, Ohio
November 3, 2016 (All times are Eastern workers who responded to the 45226.
Daylight Time). September 11, 2001, terrorist attacks in Email: nioshdocket@cdc.gov.
Place: Jacob J. Javits Federal Building, New York City, at the Pentagon, and in Telephone: (513) 533–8611.
26 Federal Plaza, New York, New York Shanksville, Pennsylvania (responders), In the event an individual cannot
10278. This meeting is also available by and to eligible persons who were attend, written comments may be
telephone and Web conference. Audio present in the dust or dust cloud on submitted. The comments should be
will be available by telephone only; September 11, 2001 or who worked, limited to two pages and submitted
visuals will be available by Web resided, or attended school, childcare, through http://www.regulations.gov by
conference. The USA toll-free, dial-in or adult daycare in the New York City October 31, 2016. Efforts will be made
number is 1–888–810–4931, and when disaster area (survivors). Certain specific to provide the two-page written
prompted enter passcode—8328289. To activities of the WTC Program comments received by the deadline
view the web conference, enter the Administrator are reserved to the above to the committee members before
following web address in your web Secretary, HHS, to delegate at her the meeting. Comments in excess of two
browser: https:// discretion; other WTC Program pages will be made publicly available at
odniosh.adobeconnect.com/wtchpstac/. Administrator duties not explicitly http://www.regulations.gov.
Public Comment Time and Date: reserved to the Secretary, HHS, are Policy on Redaction of Committee
10:45 a.m.–11:15 a.m. (Eastern Daylight assigned to the Director, NIOSH. The Meeting Transcripts (Public Comment):
Time), November 3, 2016. administration of the Advisory Transcripts will be prepared and posted
Please note that the public comment Committee is left to the Director of to http://www.regulations.gov within 60
period ends at the time indicated above NIOSH in his role as WTC Program days after the meeting. If a person
or following the last call for comments, Administrator. CDC and NIOSH provide making a comment gives his or her
whichever is earlier. Members of the funding, staffing, and administrative name, no attempt will be made to redact
public who want to comment must sign support services for the Advisory that name. NIOSH will take reasonable
up by providing their name by mail, Committee. The charter was reissued on steps to ensure that individuals making
email, or telephone, at the addresses May 12, 2015, and will expire on May public comments are aware of the fact
provided below by October 31, 2016. 12, 2017. that their comments (including their
Each commenter will be provided up to Matters for Discussion: The Advisory name, if provided) will appear in a
five minutes for comment. A limited Committee will address the new transcript of the meeting posted on a
number of time slots are available and responsibilities required under the public Web site. Such reasonable steps
will be assigned on a first come—first reauthorization of the WTC Health include a statement read at the start of
served basis. Written comments will Program in the PHS Act. Specifically, the meeting stating that transcripts will
also be accepted from those unable to the enhanced role of the STAC to: (1) be posted and names of speakers will
jstallworth on DSK7TPTVN1PROD with NOTICES
attend the public session. Make recommendations regarding the not be redacted. If individuals in
Status: Open to the public, limited identification of individuals to conduct making a statement reveal personal
only by the number of telephone lines. independent peer reviews of the information (e.g., medical information)
The conference line will accommodate evidence that would be the basis for about themselves, that information will
up to 50 callers. The room will issuing final rules to add a health not usually be redacted. The CDC
accommodate approximately 100 condition to the List of WTC-Related Freedom of Information Act coordinator
persons. Health Conditions; and (2) review and will, however, review such revelations
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![Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices 71505
in accordance with the Freedom of the collection of information on those initiated studies on autism. In FY 2006,
Information Act and, if deemed who are to respond, including through through a second CADDRE funding
appropriate, will redact such the use of appropriate automated, cycle, five grantees were awarded. The
information. Disclosures of information electronic, mechanical, or other CADDRE activities for the second
concerning third party medical technological collection techniques or funding cycle (2006–2011) were limited
information will be redacted. other forms of information technology, to implementation of the first phase of
Contact person for more information: e.g., permitting electronic submission of SEED (subsequently known as SEED 1).
Paul J. Middendorf, Ph.D., Designated responses; and (e) Assess information CDC served as the sixth CADDRE SEED
Federal Officer, NIOSH, CDC, 2400 collection costs. 1 site during this period. A second
Century Parkway NE., Mail Stop E–20, To request additional information on phase of SEED (SEED 2) was funded
Atlanta, Georgia 30345, telephone 1 the proposed project or to obtain a copy under a third funding cycle (2011–
(888) 982–4748; email: wtc-stac@ of the information collection plan and 2016). Five CADDRE grantees received
cdc.gov. instruments, call (404) 639–7570 or the awards. Again, CDC served as the
The Director, Management Analysis send an email to omb@cdc.gov. Direct sixth SEED 2 site.
and Services Office, has been delegated written comments and/or suggestions A third phase of SEED (SEED 3) was
the authority to sign Federal Register regarding the items contained in this funded in July 2016. Five extramural
notices pertaining to announcements of notice to the Attention: CDC Desk sites were funded. Together with the
meetings and other committee Officer, Office of Management and CDC, they will implement the SEED 3
management activities, for both the Budget, Washington, DC 20503 or by fax collaborative protocol. The SEED 3
Centers for Disease Control and to (202) 395–5806. Written comments protocol for identification of study
Prevention, and the Agency for Toxic should be received within 30 days of participants, recruitment, and study
Substances and Disease Registry. this notice. data collection flow will be similar to
the protocols for SEED 1 and 2.
Elaine L. Baker, Proposed Project However, while all SEED phases have
Director, Management Analysis and Services Study to Explore Early Development the same research goals and the same
Office, Centers for Disease Control and (SEED) Phase 3—New—National Center basic study design, data collection has
Prevention. on Birth Defects and Developmental been greatly streamlined and revised
[FR Doc. 2016–25039 Filed 10–14–16; 8:45 am] Disabilities (NCBDDD), Centers for between SEED 1, SEED 2, and SEED 3.
BILLING CODE 4163–18–P Disease Control and Prevention (CDC). Many study instruments and data
collection components included in the
Background and Brief Description
SEED 1 protocol are not included in the
DEPARTMENT OF HEALTH AND Autism spectrum disorders (ASD) are SEED 3 protocol; two instruments
HUMAN SERVICES a group of neurodevelopmental included in the SEED 3 protocol were
disorders characterized by qualitative developed subsequent to SEED 1 to
Centers for Disease Control and impairments in social interaction and capture an abbreviated version of
Prevention communication and stereotyped information that had been included on
[30Day–17–16PA]
behaviors and interests. Recent some of the discontinued SEED 1 forms
systematic population surveys and and to capture some additional
Agency Forms Undergoing Paperwork routine monitoring systems in the U.S. information overlooked in the SEED 1
Reduction Act Review and other countries indicate the protocol; and instruments included in
prevalence to be 1–2%. Apart from the all phases of SEED underwent review
The Centers for Disease Control and identification of some rare genetic and minor revision subsequent to SEED
Prevention (CDC) has submitted the conditions that are commonly 1 to address ambiguities and difficulties
following information collection request associated with autism, causal experienced during SEED 1 data
to the Office of Management and Budget mechanisms for the disorder largely collection. Implementing this phase of
(OMB) for review and approval in remain unknown. SEED will increase the total SEED
accordance with the Paperwork The Children’s Health Act of 2000 pooled sample size for investigation of
Reduction Act of 1995. The notice for mandated CDC to establish autism high priority hypotheses. Maintaining
the proposed information collection is surveillance and research programs to the same basic study design and general
published to obtain comments from the address the number, incidence, and protocol integrity will ensure that data
public and affected agencies. causes of autism and related pooling can be achieved across SEED
Written comments and suggestions developmental disabilities. Under the phases.
from the public and affected agencies provisions of this act, NCBDDD funded Families will be identified from each
concerning the proposed collection of five Centers for Autism and of the 3 groups: Autism Spectrum
information are encouraged. Your Developmental Disabilities Research Disorder (ASD), other developmental
comments should address any of the and Epidemiology (CADDRE) through delay or disorder comparison group
following: (a) Evaluate whether the program announcements in FY2001 and (DD), and a second comparison group of
proposed collection of information is FY2002; CDC’s NCBDDD served as the children randomly drawn from the
necessary for the proper performance of sixth CADDRE site. entire study cohort population (POP). It
the functions of the agency, including For the first funding cycle (2001– is expected that the 6 SEED 3 study sites
whether the information will have 2006), each CADDRE grantee had three will have a total of 2,106 children enroll
practical utility; (b) Evaluate the core objectives: To develop a protocol and complete the study protocol. The
jstallworth on DSK7TPTVN1PROD with NOTICES
accuracy of the agencies estimate of the for a multi-site collaborative data collection process will take
burden of the proposed collection of epidemiologic study focused on autism approximately 9 hours 10 minutes (ASD
information, including the validity of (which was eventually named the Study group); 5 hours 30 minutes (POP group);
the methodology and assumptions used; to Explore Early Development [SEED]); 2 hours 45 minutes (DD group) to
(c) Enhance the quality, utility, and to conduct surveillance of autism and complete, which includes (1) maternal
clarity of the information to be other developmental disabilities; and to telephone interview with questions
collected; (d) Minimize the burden of conduct site-specific investigator- about maternal reproductive history and
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Document Created: 2016-10-15 01:51:32
Document Modified: 2016-10-15 01:51:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | 9:00 a.m.-5:00 p.m., November 3, 2016 (All times are Eastern Daylight Time). | |
| FR Citation | 81 FR 71504 |
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