80 FR 39720 - World Trade Center Health Program; Petition 008-Autoimmune Diseases; Finding of Insufficient Evidence

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 132 (July 10, 2015)

Page Range		39720-39722
FR Document		2015-16942

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 determination not to publish a proposed rule.

Federal Register, Volume 80 Issue 132 (Friday, July 10, 2015)

[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Proposed Rules]
[Pages 39720-39722]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16942]


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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.

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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 [email protected].

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).
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    \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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    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.
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    \2\ See Petition 008. WTC Health Program: Petitions Received. 
http://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.
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    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.
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    \4\ This determination is consistent with the Administrator's 
reasoning in the Petition 007 finding of insufficient evidence. 80 
FR 32333, June 8, 2015.
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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. http://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

39720 Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Proposed Rules

202–501–1624, or by email at proposed rule is also exempt from the create significant civic-scaled artwork of
aluanda.drain@gsa.gov. For information Administrative Procedure Act per 5 outstanding quality and value. Federal
pertaining to status or publication U.S.C. 553 (a)(2) because it applies to agencies should work collaboratively
schedules, contact the Regulatory agency management or personnel. with the artist, community, and art and
Secretariat, at 202–501–4755. Please cite design professionals to produce works
D. Paperwork Reduction Act
FMR Case 2015–102–3. of art that reflect the cultural,
SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act does intellectual, and historic interests of the
not apply because the proposed changes nation and the community. Federal
A. Background to the FMR do not impose agencies should commission artwork
As part of its regular cycle to review recordkeeping or information collection that is diverse in style and media.
and update its real property policies, requirements, or the collection of ■ 4. Revise § 102–77.25 to read as
GSA is proposing to revise its policy on information from offerors, contractors, follows:
Art-in-Architecture that is located in or members of the public that require
FMR part 102–77 (41 CFR part 102–77). the approval of the Office of § 102–77.25 Do Federal agencies have
Management and Budget under 44 responsibilities to provide national visibility
This part was last revised on November
for Art-in-Architecture?
8, 2005 at 70 FR 67847. U.S.C. 3501, et seq.
Yes, Federal agencies should
Proposed Changes E. Small Business Regulatory implement these Art-in-Architecture
The proposed changes to FMR part Enforcement Fairness Act policies in a manner that receives
102–77 reflect an internal as well as an This proposed rule is exempt from appropriate national and local visibility
interagency collaborative effort. Major Congressional review prescribed by 5 to facilitate participation by a large and
proposed changes include the following: U.S.C. 801 since it relates to agency diverse group of American artists
Section 102–77.10 recommends the management and personnel. representing a wide variety of types of
practice of commissioning artwork and artwork.
List of Subjects in 41 CFR Part 102–77
also requires that the art be the work of [FR Doc. 2015–16902 Filed 7–9–15; 8:45 am]
living American artists. Arts and Crafts. BILLING CODE 6820–14–P
Section 102–77.20 proposes that to Dated: May 7, 2015.
the maximum extent possible, agencies Giancarlo Brizzi,
should collaborate with representatives Acting Associate Administrator.
of the client agency and with others DEPARTMENT OF HEALTH AND
who are tied to the project to For the reasons set forth in the HUMAN SERVICES
commission the nation’s most talented preamble, GSA proposes to amend 41
CFR part 102–77 as follows: 42 CFR Part 88
artists.
Section 102–77.25 calls for agencies to PART 102–77—ART-IN- [NIOSH Docket 094]
implement the Art-in-Architecture ARCHITECTURE
policies in a manner that receives World Trade Center Health Program;
national and local visibility to facilitate ■ 1. The authority continues to read as Petition 008—Autoimmune Diseases;
participation by a large and diverse follows: Finding of Insufficient Evidence
group of American artists.
Authority: 40 U.S.C. 121 and 3306. AGENCY: Centers for Disease Control and
B. Executive Orders 12866 and 13563 ■ 2. Revise § 102–77.10 to read as Prevention, HHS.
Executive Orders (E.O.S.) 12866 and follows: ACTION: Denial of petition for addition of
13563 direct agencies to assess all costs § 102–77.10 What basic Art-in-Architecture a health condition.
and benefits of available regulatory policy governs Federal agencies?
alternatives and, if regulation is SUMMARY: On May 11, 2015, the
Federal agencies must incorporate
necessary, to select regulatory Administrator of the World Trade
fine arts as an integral part of the total
approaches that maximize net benefits Center (WTC) Health Program received
building concept when designing new
(including potential economic, a petition (Petition 008) to add
Federal buildings, and when making
environmental, public health and safety autoimmune diseases to the List of
substantial repairs and alterations to
effects, distributive impacts, and WTC-Related Health Conditions (List).
existing Federal buildings, as
equity). E.O. 13563 emphasizes the Upon reviewing the information
appropriate. The commissioned
importance of quantifying both costs provided by the petitioner, the
artworks—including painting, sculpture
and benefits, of reducing costs, of Administrator has determined that
and various other media—must reflect
harmonizing rules, and of promoting Petition 008 is not substantially
the national cultural heritage and be the
flexibility. This is not a significant different from Petition 007, which also
work of living American artists (citizens
regulatory action, and therefore was not requested the addition of autoimmune
or permanent residents of the United
subject to review under Section 6(b) of diseases. The Administrator recently
States).
E.O. 12866, Regulatory Planning and published a response to Petition 007 in
■ 3. Revise § 102–77.20 to read as
Review, dated September 30, 1993. This the Federal Register and has
follows:
rule is not a major rule under 5 U.S.C. determined that Petition 008 does not
provide additional evidence of a causal
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804. § 102–77.20 With whom should Federal
agencies collaborate when commissioning relationship between 9/11 exposures
C. Regulatory Flexibility Act and selecting art for Federal buildings? and autoimmune diseases. Accordingly,
While these revisions are substantive, To the maximum extent practicable, the Administrator finds that insufficient
this proposed rule would not have a Federal agencies should collaborate evidence exists to request a
significant economic impact on a with representatives of the client agency recommendation of the WTC Health
substantial number of small entities and the local community, the designer, Program Scientific/Technical Advisory
within the meaning of the Regulatory and arts professionals to commission Committee (STAC), to publish a
Flexibility Act, 5 U.S.C. 601, et seq. This the nation’s most talented artists to proposed rule, or to publish a

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39722 Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Proposed Rules

diseases to the List (pursuant to PHS that the devices and applications they fjallfoss.fcc.gov/ecfs2/. (Documents will
Act, section 3312(a)(6)(B)(ii) and 42 CFR provide to subscribers include a simple be available electronically in ASCII,
88.17(a)(2)(ii)) or publishing a and easy to use activation mechanism Microsoft Word, and/or Adobe Acrobat.)
determination not to publish a proposed for accessing audible emergency This document is also available for
rule in the Federal Register (pursuant to information on the secondary audio public inspection and copying during
PHS Act, section 3312(a)(6)(B)(iii) and stream. regular business hours in the FCC
42 CFR 88.17(a)(2)(iii)). The DATES: Comments are due on or before Reference Information Center, Federal
Administrator has also determined that August 10, 2015; reply comments are Communications Commission, 445 12th
requesting a recommendation from the due on or before September 8, 2015. Street SW., CY–A257, Washington, DC,
STAC (pursuant to PHS Act, section ADDRESSES: You may submit comments, 20554. The complete text may be
3312(a)(6)(B)(i) and 42 CFR identified by MB Docket No. 12–107, by purchased from the Commission’s copy
88.17(a)(2)(i)) is unwarranted. any of the following methods: contractor, 445 12th Street SW., Room
For the reasons discussed above, the • Federal Communications CY–B402, Washington, DC 20554.
request made in Petition 008 to add Commission (FCC) Electronic Comment Alternative formats are available for
autoimmune diseases to the List of Filing System (ECFS) Web site: http:// people with disabilities (Braille, large
WTC-Related Health Conditions is fjallfoss.fcc.gov/ecfs2/. Follow the print, electronic files, audio format), by
denied. instructions for submitting comments. sending an email to fcc504@fcc.gov or
The Administrator is aware that • Mail: U.S. Postal Service first-class, calling the Commission’s Consumer and
another study of autoimmune diseases Express, and Priority mail must be Governmental Affairs Bureau at (202)
among WTC Health Program members is addressed to the FCC Secretary, Office 418–0530 (voice), (202) 418–0432
being conducted by the WTC Health of the Secretary, Federal (TTY).
Registry; however, results from this Communications Commission, 445 12th
study are not yet available in the I. Introduction
Street SW., Washington, DC 20554.
scientific literature. The Administrator Commercial overnight mail (other than 1. In this Second Further Notice of
will monitor the scientific literature for U.S. Postal Service Express Mail and Proposed Rulemaking (‘‘Second Further
publication of the results of this study Priority Mail) must be sent to 9300 East Notice’’), we seek comment on three
and any other studies that address Hampton Drive, Capitol Heights, MD issues: (i) whether we should adopt
autoimmune diseases among 9/11- 20743. rules regarding how covered entities
exposed populations. • Hand or Messenger Delivery: All should prioritize emergency information
Dated: July 1, 2015. hand-delivered or messenger-delivered conveyed aurally on the secondary
John Howard, paper filings for the FCC Secretary must audio stream when more than one
Administrator, World Trade Center Health be delivered to FCC Headquarters at 445 source of visual emergency information
Program and Director, National Institute for 12th Street SW., Room TW–A325, is presented on-screen at the same time;
Occupational Safety and Health, Centers for Washington, DC 20554. (ii) whether we should reconsider the
Disease Control and Prevention, Department • People with Disabilities: Contact the Commission’s requirement for ‘‘school
of Health and Human Services. FCC to request reasonable closings and changes in school bus
[FR Doc. 2015–16942 Filed 7–9–15; 8:45 am] accommodations (accessible format schedules’’ resulting from emergency
BILLING CODE 4163–18–P documents, sign language interpreters, situations to be conveyed aurally on the
CART, etc.) by email: FCC504@fcc.gov secondary audio stream, considering the
or phone: 202–418–0530; or TTY: 202– length of such information and the
418–0432. limits of the secondary audio stream;
FEDERAL COMMUNICATIONS For detailed instructions for
COMMISSION and (iii) whether we should require
submitting comments and additional MVPDs to ensure that the navigation
47 CFR Part 79 information on the rulemaking process, devices that they provide to subscribers
see the section IV. ‘‘Procedural Matters’’ include a simple and easy to use
[MB Docket No. 12–107; FCC 15–56] heading of the SUPPLEMENTARY activation mechanism for accessing
INFORMATION section of this document. audible emergency information on the
Accessible Emergency Information, FOR FURTHER INFORMATION CONTACT:
and Apparatus Requirements for secondary audio stream, and to provide
Evan Baranoff, Evan.Baranoff@fcc.gov, a simple and easy to use mechanism to
Emergency Information and Video of the Media Bureau, Policy Division,
Description activate the secondary audio stream for
(202) 418–2120. emergency information when they
AGENCY: Federal Communications SUPPLEMENTARY INFORMATION: This is a permit subscribers to view linear
Commission. summary of the Commission’s Second programming on mobile and other
ACTION: Proposed rule. Further Notice of Proposed Rulemaking devices as part of their MVPD services.
(Second Further Notice), FCC 15–56,
SUMMARY: In this document, the adopted on May 21, 2015, and released II. Discussion
Commission seeks comments on issues on May 28, 2015. For background, see A. Prioritization of Emergency
related to making emergency the summary of the Second Report and Information on the Secondary Audio
information audibly accessible to Order (Second Report and Order) Stream
individuals who are blind or visually accompanying the Second Further
mstockstill on DSK4VPTVN1PROD with PROPOSALS

impaired. Specifically, this document Notice published in this issue of the 2. We seek comment on how video
seeks comment on: How to prioritize Federal Register. The full text of this programming providers and video
aural emergency information on the document is available electronically via programming distributors should
secondary audio stream; whether to the FCC’s Electronic Document prioritize emergency information
continue to require school closing Management System (EDOCS) Web site conveyed aurally on the secondary
information to be included aurally on at http://fjallfoss.fcc.gov/edocs_public/ audio stream when more than one
the secondary audio stream; and or via the FCC’s Electronic Comment source of visual emergency information
whether to require MVPDs to ensure Filing System (ECFS) Web site at http:// is presented on-screen at the same time.

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Document Created: 2018-02-23 09:15:59
Document Modified: 2018-02-23 09:15:59

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		Proposed Rules
Action		Denial of petition for addition of a health condition.
Dates		The Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of July 10, 2015.
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 [email protected]
FR Citation		80 FR 39720