World Trade Center Health Program; Petition 008-Autoimmune Diseases; Finding of Insufficient Evidence, 39720-39722 [2015-16942]
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Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Proposed Rules
202–501–1624, or by email at
aluanda.drain@gsa.gov. For information
pertaining to status or publication
schedules, contact the Regulatory
Secretariat, at 202–501–4755. Please cite
FMR Case 2015–102–3.
SUPPLEMENTARY INFORMATION:
A. Background
As part of its regular cycle to review
and update its real property policies,
GSA is proposing to revise its policy on
Art-in-Architecture that is located in
FMR part 102–77 (41 CFR part 102–77).
This part was last revised on November
8, 2005 at 70 FR 67847.
proposed rule is also exempt from the
Administrative Procedure Act per 5
U.S.C. 553 (a)(2) because it applies to
agency management or personnel.
D. Paperwork Reduction Act
The Paperwork Reduction Act does
not apply because the proposed changes
to the FMR do not impose
recordkeeping or information collection
requirements, or the collection of
information from offerors, contractors,
or members of the public that require
the approval of the Office of
Management and Budget under 44
U.S.C. 3501, et seq.
create significant civic-scaled artwork of
outstanding quality and value. Federal
agencies should work collaboratively
with the artist, community, and art and
design professionals to produce works
of art that reflect the cultural,
intellectual, and historic interests of the
nation and the community. Federal
agencies should commission artwork
that is diverse in style and media.
■ 4. Revise § 102–77.25 to read as
follows:
§ 102–77.25 Do Federal agencies have
responsibilities to provide national visibility
for Art-in-Architecture?
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Proposed Changes
The proposed changes to FMR part
102–77 reflect an internal as well as an
interagency collaborative effort. Major
proposed changes include the following:
Section 102–77.10 recommends the
practice of commissioning artwork and
also requires that the art be the work of
living American artists.
Section 102–77.20 proposes that to
the maximum extent possible, agencies
should collaborate with representatives
of the client agency and with others
who are tied to the project to
commission the nation’s most talented
artists.
Section 102–77.25 calls for agencies to
implement the Art-in-Architecture
policies in a manner that receives
national and local visibility to facilitate
participation by a large and diverse
group of American artists.
E. Small Business Regulatory
Enforcement Fairness Act
This proposed rule is exempt from
Congressional review prescribed by 5
U.S.C. 801 since it relates to agency
management and personnel.
List of Subjects in 41 CFR Part 102–77
Arts and Crafts.
Yes, Federal agencies should
implement these Art-in-Architecture
policies in a manner that receives
appropriate national and local visibility
to facilitate participation by a large and
diverse group of American artists
representing a wide variety of types of
artwork.
[FR Doc. 2015–16902 Filed 7–9–15; 8:45 am]
B. Executive Orders 12866 and 13563
Executive Orders (E.O.S.) 12866 and
13563 direct agencies to assess all costs
and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This is not a significant
regulatory action, and therefore was not
subject to review under Section 6(b) of
E.O. 12866, Regulatory Planning and
Review, dated September 30, 1993. This
rule is not a major rule under 5 U.S.C.
804.
■
C. Regulatory Flexibility Act
While these revisions are substantive,
this proposed rule would not have a
significant economic impact on a
substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq. This
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Dated: May 7, 2015.
Giancarlo Brizzi,
Acting Associate Administrator.
For the reasons set forth in the
preamble, GSA proposes to amend 41
CFR part 102–77 as follows:
1. The authority continues to read as
follows:
■
Authority: 40 U.S.C. 121 and 3306.
2. Revise § 102–77.10 to read as
follows:
§ 102–77.10 What basic Art-in-Architecture
policy governs Federal agencies?
Federal agencies must incorporate
fine arts as an integral part of the total
building concept when designing new
Federal buildings, and when making
substantial repairs and alterations to
existing Federal buildings, as
appropriate. The commissioned
artworks—including painting, sculpture
and various other media—must reflect
the national cultural heritage and be the
work of living American artists (citizens
or permanent residents of the United
States).
■ 3. Revise § 102–77.20 to read as
follows:
§ 102–77.20 With whom should Federal
agencies collaborate when commissioning
and selecting art for Federal buildings?
To the maximum extent practicable,
Federal agencies should collaborate
with representatives of the client agency
and the local community, the designer,
and arts professionals to commission
the nation’s most talented artists to
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 88
[NIOSH Docket 094]
PART 102–77—ART-INARCHITECTURE
PO 00000
BILLING CODE 6820–14–P
World Trade Center Health Program;
Petition 008—Autoimmune Diseases;
Finding of Insufficient Evidence
Centers for Disease Control and
Prevention, HHS.
ACTION: Denial of petition for addition of
a health condition.
AGENCY:
On May 11, 2015, the
Administrator of the World Trade
Center (WTC) Health Program received
a petition (Petition 008) to add
autoimmune diseases to the List of
WTC-Related Health Conditions (List).
Upon reviewing the information
provided by the petitioner, the
Administrator has determined that
Petition 008 is not substantially
different from Petition 007, which also
requested the addition of autoimmune
diseases. The Administrator recently
published a response to Petition 007 in
the Federal Register and has
determined that Petition 008 does not
provide additional evidence of a causal
relationship between 9/11 exposures
and autoimmune diseases. Accordingly,
the Administrator finds that insufficient
evidence exists to request a
recommendation of the WTC Health
Program Scientific/Technical Advisory
Committee (STAC), to publish a
proposed rule, or to publish a
SUMMARY:
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Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Proposed Rules
determination not to publish a proposed
rule.
DATES: The Administrator of the WTC
Health Program is denying this petition
for the addition of a health condition as
of July 10, 2015.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C–46,
Cincinnati, OH 45226; telephone (855)
818–1629 (this is a toll-free number);
email NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
A. WTC Health Program Statutory Authority
B. Petition 008
C. Administrator’s Determination on Petition
008
mstockstill on DSK4VPTVN1PROD with PROPOSALS
A. WTC Health Program Statutory
Authority
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010
(Pub. L. 111–347), amended the Public
Health Service Act (PHS Act) to add
Title XXXIII 1 establishing 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).
All references to the Administrator of
the WTC Health Program
(Administrator) in this notice mean the
Director of the National Institute for
Occupational Safety and Health
(NIOSH) or his or her designee.
Pursuant to section 3312(a)(6)(B) of
the PHS Act, interested parties may
petition the Administrator to add a
health condition to the List in 42 CFR
88.1. Within 60 calendar days after
receipt of a petition to add a condition
to the List, the Administrator must take
one of the following four actions
described in section 3312(a)(6)(B) and
42 CFR 88.17: (i) Request a
recommendation of the STAC; (ii)
publish a proposed rule in the Federal
Register to add such health condition;
1 Title XXXIII of the PHS Act is codified at 42
U.S.C. 300mm to 300mm–61. Those portions of the
Zadroga Act found in Titles II and III of Public Law
111–347 do not pertain to the WTC Health Program
and are codified elsewhere.
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17:25 Jul 09, 2015
Jkt 235001
(iii) publish in the Federal Register the
Administrator’s determination not to
publish such a proposed rule and the
basis for such determination; or (iv)
publish in the Federal Register a
determination that insufficient evidence
exists to take action under (i) through
(iii) above. However, in accordance with
42 CFR 88.17(a)(4), the Administrator is
required to consider a new petition for
a previously-evaluated health condition
determined not to qualify for addition to
the List only if the new petition presents
a new medical basis—evidence not
previously reviewed by the
Administrator—for the association
between 9/11 exposures and the
condition to be added.
B. Petition 008
On May 11, 2015, the Administrator
received a petition to add ‘‘autoimmune
disease—encephalitis of the brain’’ to
the List (Petition 008).2 This is the
second petition to the Administrator
requesting the addition of autoimmune
diseases to the List; the first
autoimmune disease petition, Petition
007, was denied due to insufficient
evidence as described in a Federal
Register notice published on June 8,
2015 (80 FR 32333). Petition 008, which
is addressed in this notice, was
submitted by a WTC Health Program
member who responded to the
September 11, 2001, terrorist attacks in
New York City. The petitioner indicated
that she has been diagnosed with
encephalitis as well as two WTC-related
health conditions. The petition
presented as evidence several
newspaper articles referencing a study
recently published in the Journal of
Arthritis and Rheumatology by Webber
et al. [2015],3 which was designed to
test the hypothesis that acute and
chronic 9/11 work-related exposures
were associated with the risk of certain
new-onset systemic autoimmune
diseases.
Although Petition 008 specifically
requested the addition of ‘‘autoimmune
disease—encephalitis of the brain,’’ the
Administrator determined that the
scope of the petition properly includes
only the autoimmune diseases
identified in Webber et al., cited as
evidence in both Petition 007 and
Petition 008.4 Encephalitis is not among
2 See Petition 008. WTC Health Program: Petitions
Received. https://www.cdc.gov/wtc/received.html.
3 Webber MP, Moir W, Zeig-Owens R, Glaser MS,
Jaber N, Hall C, Berman J, Qayyum B, Loupasakis
K, Kelly K, and Prezant DJ [20015]. Nested casecontrol study of selected systemic autoimmune
diseases in World Trade Center rescue/recovery
workers. Journal of Arthritis & Rheumatology
67(5):1369–1376.
4 This determination is consistent with the
Administrator’s reasoning in the Petition 007
PO 00000
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39721
the autoimmune diseases studied by
Webber et al. No other evidence was
provided in Petition 008 to support the
addition of encephalitis to the List;
therefore, encephalitis is not addressed
in this action.
C. Administrator’s Determination on
Petition 008
The Administrator has established a
methodology for evaluating whether to
add non-cancer health conditions to the
List of WTC-Related Health Conditions,
published online in the Policies and
Procedures section of the WTC Health
Program Web site.5 However, the
Administrator has determined that the
methodology is not triggered in this case
because Petition 008 requested the
addition of a health condition that was
previously reviewed by the Program,
and presented no new evidence of a
causal association between 9/11
exposures and autoimmune diseases. In
a response to Petition 007, which also
requested the addition of autoimmune
diseases, published in the Federal
Register on June 8, 2015 (80 FR 32333),
the Administrator reviewed the findings
presented in the Webber study and
determined that insufficient evidence
exists to take any of the following
actions: Propose the addition of
autoimmune diseases to the List
(pursuant to PHS Act, section
3312(a)(6)(B)(ii) and 42 CFR
88.17(a)(2)(ii)); publish a determination
not to publish a proposed rule in the
Federal Register (pursuant to PHS Act,
section 3312(a)(6)(B)(iii) and 42 CFR
88.17(a)(2)(iii)); or request a
recommendation from the STAC
(pursuant to PHS Act, section
3312(a)(6)(B)(i) and 42 CFR
88.17(a)(2)(i)). Because the
Administrator recently evaluated the
Webber study, presented as evidence for
the addition of autoimmune conditions
in Petition 007, there is no need to
reevaluate the same evidence again in
response to the request to add
autoimmune diseases in Petition 008,
which also presented the Webber study
as evidence of a causal association
between 9/11 exposures and
autoimmune diseases.
Accordingly, with regard to Petition
008, the Administrator has determined
that insufficient evidence exists to take
further action, including either
proposing the addition of autoimmune
finding of insufficient evidence. 80 FR 32333, June
8, 2015.
5 ‘‘Policy and Procedures for Adding Non-Cancer
Conditions to the List of WTC-Related Health
Conditions,’’ John Howard MD, Administrator of
the WTC Health Program, October 21, 2014. https://
www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancers_21_Oct_2014.pdf.
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39722
Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Proposed Rules
diseases to the List (pursuant to PHS
Act, section 3312(a)(6)(B)(ii) and 42 CFR
88.17(a)(2)(ii)) or publishing a
determination not to publish a proposed
rule in the Federal Register (pursuant to
PHS Act, section 3312(a)(6)(B)(iii) and
42 CFR 88.17(a)(2)(iii)). The
Administrator has also determined that
requesting a recommendation from the
STAC (pursuant to PHS Act, section
3312(a)(6)(B)(i) and 42 CFR
88.17(a)(2)(i)) is unwarranted.
For the reasons discussed above, the
request made in Petition 008 to add
autoimmune diseases to the List of
WTC-Related Health Conditions is
denied.
The Administrator is aware that
another study of autoimmune diseases
among WTC Health Program members is
being conducted by the WTC Health
Registry; however, results from this
study are not yet available in the
scientific literature. The Administrator
will monitor the scientific literature for
publication of the results of this study
and any other studies that address
autoimmune diseases among 9/11exposed populations.
Dated: July 1, 2015.
John Howard,
Administrator, World Trade Center Health
Program and Director, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention, Department
of Health and Human Services.
[FR Doc. 2015–16942 Filed 7–9–15; 8:45 am]
BILLING CODE 4163–18–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 79
[MB Docket No. 12–107; FCC 15–56]
Accessible Emergency Information,
and Apparatus Requirements for
Emergency Information and Video
Description
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
In this document, the
Commission seeks comments on issues
related to making emergency
information audibly accessible to
individuals who are blind or visually
impaired. Specifically, this document
seeks comment on: How to prioritize
aural emergency information on the
secondary audio stream; whether to
continue to require school closing
information to be included aurally on
the secondary audio stream; and
whether to require MVPDs to ensure
mstockstill on DSK4VPTVN1PROD with PROPOSALS
SUMMARY:
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17:25 Jul 09, 2015
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that the devices and applications they
provide to subscribers include a simple
and easy to use activation mechanism
for accessing audible emergency
information on the secondary audio
stream.
DATES: Comments are due on or before
August 10, 2015; reply comments are
due on or before September 8, 2015.
ADDRESSES: You may submit comments,
identified by MB Docket No. 12–107, by
any of the following methods:
• Federal Communications
Commission (FCC) Electronic Comment
Filing System (ECFS) Web site: https://
fjallfoss.fcc.gov/ecfs2/. Follow the
instructions for submitting comments.
• Mail: U.S. Postal Service first-class,
Express, and Priority mail must be
addressed to the FCC Secretary, Office
of the Secretary, Federal
Communications Commission, 445 12th
Street SW., Washington, DC 20554.
Commercial overnight mail (other than
U.S. Postal Service Express Mail and
Priority Mail) must be sent to 9300 East
Hampton Drive, Capitol Heights, MD
20743.
• Hand or Messenger Delivery: All
hand-delivered or messenger-delivered
paper filings for the FCC Secretary must
be delivered to FCC Headquarters at 445
12th Street SW., Room TW–A325,
Washington, DC 20554.
• People with Disabilities: Contact the
FCC to request reasonable
accommodations (accessible format
documents, sign language interpreters,
CART, etc.) by email: FCC504@fcc.gov
or phone: 202–418–0530; or TTY: 202–
418–0432.
For detailed instructions for
submitting comments and additional
information on the rulemaking process,
see the section IV. ‘‘Procedural Matters’’
heading of the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
Evan Baranoff, Evan.Baranoff@fcc.gov,
of the Media Bureau, Policy Division,
(202) 418–2120.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Second
Further Notice of Proposed Rulemaking
(Second Further Notice), FCC 15–56,
adopted on May 21, 2015, and released
on May 28, 2015. For background, see
the summary of the Second Report and
Order (Second Report and Order)
accompanying the Second Further
Notice published in this issue of the
Federal Register. The full text of this
document is available electronically via
the FCC’s Electronic Document
Management System (EDOCS) Web site
at https://fjallfoss.fcc.gov/edocs_public/
or via the FCC’s Electronic Comment
Filing System (ECFS) Web site at https://
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
fjallfoss.fcc.gov/ecfs2/. (Documents will
be available electronically in ASCII,
Microsoft Word, and/or Adobe Acrobat.)
This document is also available for
public inspection and copying during
regular business hours in the FCC
Reference Information Center, Federal
Communications Commission, 445 12th
Street SW., CY–A257, Washington, DC,
20554. The complete text may be
purchased from the Commission’s copy
contractor, 445 12th Street SW., Room
CY–B402, Washington, DC 20554.
Alternative formats are available for
people with disabilities (Braille, large
print, electronic files, audio format), by
sending an email to fcc504@fcc.gov or
calling the Commission’s Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY).
I. Introduction
1. In this Second Further Notice of
Proposed Rulemaking (‘‘Second Further
Notice’’), we seek comment on three
issues: (i) whether we should adopt
rules regarding how covered entities
should prioritize emergency information
conveyed aurally on the secondary
audio stream when more than one
source of visual emergency information
is presented on-screen at the same time;
(ii) whether we should reconsider the
Commission’s requirement for ‘‘school
closings and changes in school bus
schedules’’ resulting from emergency
situations to be conveyed aurally on the
secondary audio stream, considering the
length of such information and the
limits of the secondary audio stream;
and (iii) whether we should require
MVPDs to ensure that the navigation
devices that they provide to subscribers
include a simple and easy to use
activation mechanism for accessing
audible emergency information on the
secondary audio stream, and to provide
a simple and easy to use mechanism to
activate the secondary audio stream for
emergency information when they
permit subscribers to view linear
programming on mobile and other
devices as part of their MVPD services.
II. Discussion
A. Prioritization of Emergency
Information on the Secondary Audio
Stream
2. We seek comment on how video
programming providers and video
programming distributors should
prioritize emergency information
conveyed aurally on the secondary
audio stream when more than one
source of visual emergency information
is presented on-screen at the same time.
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]]>Agencies
[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Proposed Rules]
[Pages 39720-39722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16942]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 88
[NIOSH Docket 094]
World Trade Center Health Program; Petition 008--Autoimmune
Diseases; Finding of Insufficient Evidence
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Denial of petition for addition of a health condition.
-----------------------------------------------------------------------
SUMMARY: On May 11, 2015, the Administrator of the World Trade Center
(WTC) Health Program received a petition (Petition 008) to add
autoimmune diseases to the List of WTC-Related Health Conditions
(List). Upon reviewing the information provided by the petitioner, the
Administrator has determined that Petition 008 is not substantially
different from Petition 007, which also requested the addition of
autoimmune diseases. The Administrator recently published a response to
Petition 007 in the Federal Register and has determined that Petition
008 does not provide additional evidence of a causal relationship
between 9/11 exposures and autoimmune diseases. Accordingly, the
Administrator finds that insufficient evidence exists to request a
recommendation of the WTC Health Program Scientific/Technical Advisory
Committee (STAC), to publish a proposed rule, or to publish a
[[Page 39721]]
determination not to publish a proposed rule.
DATES: The Administrator of the WTC Health Program is denying this
petition for the addition of a health condition as of July 10, 2015.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090
Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-
1629 (this is a toll-free number); email NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
A. WTC Health Program Statutory Authority
B. Petition 008
C. Administrator's Determination on Petition 008
A. WTC Health Program Statutory Authority
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act)
to add Title XXXIII \1\ establishing 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).
---------------------------------------------------------------------------
\1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm
to 300mm-61. Those portions of the Zadroga Act found in Titles II
and III of Public Law 111-347 do not pertain to the WTC Health
Program and are codified elsewhere.
---------------------------------------------------------------------------
All references to the Administrator of the WTC Health Program
(Administrator) in this notice mean the Director of the National
Institute for Occupational Safety and Health (NIOSH) or his or her
designee.
Pursuant to section 3312(a)(6)(B) of the PHS Act, interested
parties may petition the Administrator to add a health condition to the
List in 42 CFR 88.1. Within 60 calendar days after receipt of a
petition to add a condition to the List, the Administrator must take
one of the following four actions described in section 3312(a)(6)(B)
and 42 CFR 88.17: (i) Request a recommendation of the STAC; (ii)
publish a proposed rule in the Federal Register to add such health
condition; (iii) publish in the Federal Register the Administrator's
determination not to publish such a proposed rule and the basis for
such determination; or (iv) publish in the Federal Register a
determination that insufficient evidence exists to take action under
(i) through (iii) above. However, in accordance with 42 CFR
88.17(a)(4), the Administrator is required to consider a new petition
for a previously-evaluated health condition determined not to qualify
for addition to the List only if the new petition presents a new
medical basis--evidence not previously reviewed by the Administrator--
for the association between 9/11 exposures and the condition to be
added.
B. Petition 008
On May 11, 2015, the Administrator received a petition to add
``autoimmune disease--encephalitis of the brain'' to the List (Petition
008).\2\ This is the second petition to the Administrator requesting
the addition of autoimmune diseases to the List; the first autoimmune
disease petition, Petition 007, was denied due to insufficient evidence
as described in a Federal Register notice published on June 8, 2015 (80
FR 32333). Petition 008, which is addressed in this notice, was
submitted by a WTC Health Program member who responded to the September
11, 2001, terrorist attacks in New York City. The petitioner indicated
that she has been diagnosed with encephalitis as well as two WTC-
related health conditions. The petition presented as evidence several
newspaper articles referencing a study recently published in the
Journal of Arthritis and Rheumatology by Webber et al. [2015],\3\ which
was designed to test the hypothesis that acute and chronic 9/11 work-
related exposures were associated with the risk of certain new-onset
systemic autoimmune diseases.
---------------------------------------------------------------------------
\2\ See Petition 008. WTC Health Program: Petitions Received.
https://www.cdc.gov/wtc/received.html.
\3\ Webber MP, Moir W, Zeig-Owens R, Glaser MS, Jaber N, Hall C,
Berman J, Qayyum B, Loupasakis K, Kelly K, and Prezant DJ [20015].
Nested case-control study of selected systemic autoimmune diseases
in World Trade Center rescue/recovery workers. Journal of Arthritis
& Rheumatology 67(5):1369-1376.
---------------------------------------------------------------------------
Although Petition 008 specifically requested the addition of
``autoimmune disease--encephalitis of the brain,'' the Administrator
determined that the scope of the petition properly includes only the
autoimmune diseases identified in Webber et al., cited as evidence in
both Petition 007 and Petition 008.\4\ Encephalitis is not among the
autoimmune diseases studied by Webber et al. No other evidence was
provided in Petition 008 to support the addition of encephalitis to the
List; therefore, encephalitis is not addressed in this action.
---------------------------------------------------------------------------
\4\ This determination is consistent with the Administrator's
reasoning in the Petition 007 finding of insufficient evidence. 80
FR 32333, June 8, 2015.
---------------------------------------------------------------------------
C. Administrator's Determination on Petition 008
The Administrator has established a methodology for evaluating
whether to add non-cancer health conditions to the List of WTC-Related
Health Conditions, published online in the Policies and Procedures
section of the WTC Health Program Web site.\5\ However, the
Administrator has determined that the methodology is not triggered in
this case because Petition 008 requested the addition of a health
condition that was previously reviewed by the Program, and presented no
new evidence of a causal association between 9/11 exposures and
autoimmune diseases. In a response to Petition 007, which also
requested the addition of autoimmune diseases, published in the Federal
Register on June 8, 2015 (80 FR 32333), the Administrator reviewed the
findings presented in the Webber study and determined that insufficient
evidence exists to take any of the following actions: Propose the
addition of autoimmune diseases to the List (pursuant to PHS Act,
section 3312(a)(6)(B)(ii) and 42 CFR 88.17(a)(2)(ii)); publish a
determination not to publish a proposed rule in the Federal Register
(pursuant to PHS Act, section 3312(a)(6)(B)(iii) and 42 CFR
88.17(a)(2)(iii)); or request a recommendation from the STAC (pursuant
to PHS Act, section 3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)).
Because the Administrator recently evaluated the Webber study,
presented as evidence for the addition of autoimmune conditions in
Petition 007, there is no need to reevaluate the same evidence again in
response to the request to add autoimmune diseases in Petition 008,
which also presented the Webber study as evidence of a causal
association between 9/11 exposures and autoimmune diseases.
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\5\ ``Policy and Procedures for Adding Non-Cancer Conditions to
the List of WTC-Related Health Conditions,'' John Howard MD,
Administrator of the WTC Health Program, October 21, 2014. https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
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Accordingly, with regard to Petition 008, the Administrator has
determined that insufficient evidence exists to take further action,
including either proposing the addition of autoimmune
[[Page 39722]]
diseases to the List (pursuant to PHS Act, section 3312(a)(6)(B)(ii)
and 42 CFR 88.17(a)(2)(ii)) or publishing a determination not to
publish a proposed rule in the Federal Register (pursuant to PHS Act,
section 3312(a)(6)(B)(iii) and 42 CFR 88.17(a)(2)(iii)). The
Administrator has also determined that requesting a recommendation from
the STAC (pursuant to PHS Act, section 3312(a)(6)(B)(i) and 42 CFR
88.17(a)(2)(i)) is unwarranted.
For the reasons discussed above, the request made in Petition 008
to add autoimmune diseases to the List of WTC-Related Health Conditions
is denied.
The Administrator is aware that another study of autoimmune
diseases among WTC Health Program members is being conducted by the WTC
Health Registry; however, results from this study are not yet available
in the scientific literature. The Administrator will monitor the
scientific literature for publication of the results of this study and
any other studies that address autoimmune diseases among 9/11-exposed
populations.
Dated: July 1, 2015.
John Howard,
Administrator, World Trade Center Health Program and Director, National
Institute for Occupational Safety and Health, Centers for Disease
Control and Prevention, Department of Health and Human Services.
[FR Doc. 2015-16942 Filed 7-9-15; 8:45 am]
BILLING CODE 4163-18-P
