81_FR_60499 81 FR 60329 - World Trade Center Health Program; Petition 013-Autoimmune Disease; Finding of Insufficient Evidence

81 FR 60329 - World Trade Center Health Program; Petition 013-Autoimmune Disease; Finding of Insufficient Evidence

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 170 (September 1, 2016)

Page Range60329-60332
FR Document2016-21070

On April 4, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 013) to add ``relapsing remitting multiple sclerosis (autoimmune)'' to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 013 is not substantially different from Petitions 007, 008, 009, and 011, which also requested the addition of autoimmune diseases, including various subtypes. The Administrator recently published responses to the four previous petitions in the Federal Register and has determined that Petition 013 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases, including multiple sclerosis. 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 81 Issue 170 (Thursday, September 1, 2016)
[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Proposed Rules]
[Pages 60329-60332]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21070]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[NIOSH Docket 094]


World Trade Center Health Program; Petition 013--Autoimmune 
Disease; Finding of Insufficient Evidence

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Denial of petition for addition of a health condition.

-----------------------------------------------------------------------

SUMMARY: On April 4, 2016, the Administrator of the World Trade Center 
(WTC) Health Program received a petition (Petition 013) to add 
``relapsing remitting multiple sclerosis (autoimmune)'' to the List of 
WTC-Related Health Conditions (List). Upon reviewing the information 
provided by the petitioner, the Administrator has determined that 
Petition 013 is not substantially different from Petitions

[[Page 60330]]

007, 008, 009, and 011, which also requested the addition of autoimmune 
diseases, including various subtypes. The Administrator recently 
published responses to the four previous petitions in the Federal 
Register and has determined that Petition 013 does not provide 
additional evidence of a causal relationship between 9/11 exposures and 
autoimmune diseases, including multiple sclerosis. 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.

DATES: The Administrator of the WTC Health Program is denying this 
petition for the addition of a health condition as of September 1, 
2016.

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. Approval To Submit Document to the Office of the Federal Register
C. Petition 013
D. Administrator's Determination on Petition 013

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title 
XXXIII to the Public Health Service Act (PHS Act),\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 90 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: (1) Request a recommendation of the STAC; (2) publish a proposed 
rule in the Federal Register to add such health condition; (3) publish 
in the Federal Register the Administrator's determination not to 
publish such a proposed rule and the basis for such determination; or 
(4) publish in the Federal Register a determination that insufficient 
evidence exists to take action under (1) through (3) 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. Approval To Submit Document to the Office of the Federal Register

    The Secretary, HHS, or her designee, the Director, Centers for 
Disease Control and Prevention (CDC) and Administrator, Agency for 
Toxic Substances and Disease Registry (ATSDR), authorized the 
undersigned, the Administrator of the WTC Health Program, to sign and 
submit the document to the Office of the Federal Register for 
publication as an official document of the WTC Health Program. Thomas 
R. Frieden, M.D., M.P.H., Director, CDC, and Administrator, ATSDR, 
approved this document for publication on August 24, 2016.

C. Petition 013

    On April 4, 2016, the Administrator received a petition from a 
responder in the WTC Health Program to add ``relapsing remitting 
multiple sclerosis (autoimmune)'' to the List (Petition 013).\2\ 
Because the petitioner identified the requested health condition as 
``the autoimmune disease of multiple sclerosis'' in the petition 
narrative and used a study of autoimmune diseases among WTC responders 
to provide the medical basis for the petition,\3\ the Administrator 
determined that the petitioned health condition is ``autoimmune 
diseases, including multiple sclerosis.''
---------------------------------------------------------------------------

    \2\ See Petition 013, WTC Health Program: Petitions Received, 
http://www.cdc.gov/wtc/received.html.
    \3\ Id.
---------------------------------------------------------------------------

    This is the fifth petition to the Administrator requesting the 
addition of autoimmune diseases, including various subtypes, to the 
List; each of the first four autoimmune disease petitions were denied 
due to insufficient evidence, as described in respective Federal 
Register notices (FRNs).\4\ The medical basis for a potential addition 
to the List may be demonstrated by reference to a peer-reviewed, 
published, epidemiologic study about the health condition among 9/11-
exposed populations or to clinical case reports of health conditions in 
WTC responders or survivors.\5\ In accordance with WTC Health Program 
policy, the Science Team reviews references for relevance, and relevant 
studies are further reviewed for quality and quantity.\6\ The current 
petition, Petition 013, presented five references to support the 
request to add ``relapsing remitting multiple sclerosis (autoimmune)'' 
to the List.
---------------------------------------------------------------------------

    \4\ ``World Trade Center Health Program; Petition 007--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 80 FR 32333 
(June 8, 2015); ``World Trade Center Health Program; Petition 008--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 80 FR 39720 
(July 10, 2015); ``World Trade Center Health Program; Petition 009--
Autoimmune Diseases; Finding of Insufficient Evidence,'' 80 FR 65980 
(Oct. 28, 2015); and ``World Trade Center Health Program; Petition 
011--Autoimmune Diseases; Finding of Insufficient Evidence,'' 81 FR 
24047 (April 25, 2016).
    \5\ See John Howard, Administrator of the WTC Health Program, 
Policy and Procedures for Handling Submissions and Petitions to Add 
a Health Condition to the List of WTC-Related Health Conditions, May 
14, 2014, http://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.
    \6\ Information is determined to be relevant if it is presented 
in peer-reviewed, published, epidemiologic studies of the health 
condition in 9/11-exposed populations. John Howard, Administrator of 
the WTC Health Program, Policy and Procedures for Adding Non-Cancer 
Conditions to the List of WTC-Related Health Conditions, May 11, 
2016, http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.
---------------------------------------------------------------------------

    Petition 013 references 1, 2, and 4 are links to the same newspaper 
article announcing the online publication of a study published in 
2015.\7\ Petition 013

[[Page 60331]]

reference 3 is a different newspaper article announcing the online 
publication of the same study.\8\ These four references identify a 2015 
study by Webber et al., a peer-reviewed, published epidemiologic study 
of autoimmune diseases among 9/11-exposed responders and survivors, 
titled ``Nested Case-Control Study of Selected Systemic Autoimmune 
Diseases in World Trade Center Rescue/Recovery Workers.'' \9\ The 2015 
Webber et al. study has already been evaluated by the Administrator in 
consideration of the other four autoimmune disease petitions, and is 
discussed below.
---------------------------------------------------------------------------

    \7\ The article, by Amy Norton, is published in reference 1, New 
Health Worry for 9/11 Recovery Workers, HealthDay, March 19, 2015, 
in www.cbsnews.com/news/ground-zero-workers-at-risk-of-autoimmune-diseases; reference 2, `Ground Zero' Workers at Risk of Autoimmune 
Diseases: Study, HealthDay, March 19, 2015, in http://www.medicinenet.com/script/main/art.asp?articlekey=187534; and 
reference 4, `Ground Zero' Workers at Risk of Autoimmune Diseases: 
Study, HealthDay, March 19, 2015, https://consumer.healthday.com/senior-citizen-information-31/misc-arthritis-news-41/ground-zero-workers-at-risk-of-autoimmune-diseases-study-697581.html. The study 
announced in the Norton article is the 2015 study by Webber et al., 
cited infra note 9.
    \8\ Nancy Walsh, Autoimmunity Rising in 9/11 Workers, MedPage 
Today, March 19, 2015, http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/50548.
    \9\ Mayris Webber, William Moir, Rachel Zeig-Owens, et al., 
Nested Case-Control Study of Selected Systemic Autoimmune Diseases 
in World Trade Center Rescue/Recovery Workers, Arthritis Rheumatol 
2015;67(5):1369-1376.
---------------------------------------------------------------------------

    The fifth reference provided in Petition 013 does not specifically 
identify a peer-reviewed, published epidemiologic study of the health 
condition among 9/11-exposed populations, nor is it a clinical case 
report of the health condition in WTC responders or survivors. Petition 
013 reference 5 is a link to the proceedings of a research meeting 
conducted by the WTC Health Program in 2014.\10\ Two abstracts found in 
the proceedings address the topic of autoimmune disease among the 9/11 
population--``Autoimmune Disease among WTCHR [World Trade Center Health 
Registry] Registrants: Survey Design and Preliminary Response Rates,'' 
and ``Post-9/11 Incidence of Systemic Autoimmune Diseases in the FDNY 
Cohort.'' The former abstract references an unpublished study; because 
unpublished studies do not meet the Program's standard for relevance, 
it was not further considered. The latter abstract describes a study 
that resulted in the 2015 Webber et al. publication discussed in this 
action and reviewed in full in the April 2016 FRN for Petition 011.
---------------------------------------------------------------------------

    \10\ WTC Health Program, Research Meeting Proceedings, June 17-
18, 2014, www.cdc.gov/wtc/proceedings.html.
---------------------------------------------------------------------------

    As discussed in the April 2016 FRN finding of insufficient evidence 
for Petition 011, the 2015 Webber et al. study looked at the 
association between 9/11-related exposures and systemic autoimmune 
diseases. It was found to be a published, peer-reviewed epidemiologic 
study of autoimmune diseases in the 9/11 population, and therefore 
deemed relevant. However, the study was found to exhibit substantial 
limitations, and it was ultimately concluded not to have the potential 
to form the basis for a decision on whether to propose adding 
autoimmune diseases to the List of WTC-Related Health Conditions.\11\
---------------------------------------------------------------------------

    \11\ 81 FR 24047 at 24049.
---------------------------------------------------------------------------

    In addition to a review of the studies presented in Petition 013, 
the WTC Health Program Science Team conducted a review of the 
scientific literature to determine if the available scientific 
information has the potential to provide a basis for a decision on 
whether to add the condition to the List. A previously conducted 
literature review for autoimmune diseases in response to Petition 007 
\12\ included all of the autoimmune conditions in the 2015 Webber et 
al. study.\13\ In reviewing Petition 013, the Science Team conducted a 
search to update the results of the previous literature review for all 
of the types of autoimmune diseases identified in the 2015 Webber et 
al. study, and also conducted a separate search for published, peer-
reviewed studies of multiple sclerosis in 9/11 populations.\14\
---------------------------------------------------------------------------

    \12\ See 80 FR 32333 at 32334.
    \13\ Rheumatoid arthritis; spondyloarthritis; inflammatory 
myositis (polymyositis and dermatomyositis); systemic lupus 
erythematosus; systemic sclerosis (scleroderma); Sjogren's syndrome; 
antiphospholipid syndrome; granulomatosis with polyangiitis 
(Wegener's); and eosinophilic granulomatosis with polyangiitis 
(Churg-Strauss).
    \14\ Databases searched include: CINAHL, Embase, NIOSHTIC-2, 
PsycINFO, PubMed, Scopus, Toxicology Abstracts, and TOXLINE.
---------------------------------------------------------------------------

    The Science Team identified five additional references to review 
for relevance. Of the five additional references, only one study, 
published in 2016 by Webber et al.,\15\ was found to be a relevant, 
published, peer-reviewed study of autoimmune diseases in 9/11-exposed 
populations. No published, peer-reviewed epidemiologic studies of 
multiple sclerosis in 9/11-exposed populations were identified in the 
literature search.
---------------------------------------------------------------------------

    \15\ Mayris Webber, William Moir, Cynthia Crowson, et al., Post-
September 11, 2001, Incidence of Systemic Autoimmune Diseases in 
World Trade Center-Exposed Firefighters and Emergency Medical 
Service Workers, Mayo Clin Proc 2016;91(1):23-32.
---------------------------------------------------------------------------

    The 2016 Webber et al. study is a follow-up to the 2015 Webber et 
al. study discussed above. The 2016 Webber et al. study looked at the 
same cohort of FDNY rescue/recovery workers included in the 2015 study 
to estimate the incidence of systemic autoimmune diseases in the cohort 
of FDNY rescue/recovery workers and to compare the FDNY incidence rates 
to demographically similar men and other published rates. This 
additional reference, the 2016 Webber et al. study, was also identified 
as relevant in the literature search for Petition 011. As a result, it 
was further reviewed in the April 2016 FRN for Petition 011 and, along 
with the 2015 Webber et al. study, evaluated for quantity and quality 
to provide a sufficient basis for deciding whether to propose an 
addition to the List. Significant limitations, discussed in the April 
2016 FRN for Petition 011, led the WTC Health Program to conclude that 
the 2015 Webber et al., and the 2016 Webber et al. study together do 
not have the potential to provide a basis for a decision on whether to 
propose adding autoimmune diseases to the List.
    All of the references and potential medical bases presented in 
Petition 013 were previously identified and assessed in Petition 011; 
as discussed above, these medical bases had significant limitations 
that prevented them from having the potential to provide a basis to 
propose adding autoimmune diseases to the List. The Science Team did 
not find any information during their review of Petition 013 which 
would alter the assessment of the previously reviewed studies. 
Moreover, none of the studies identified, including the 2015 and 2016 
Webber et al. studies, include multiple sclerosis. Thus, no evidence 
was found specific to multiple sclerosis which would have the potential 
to form the basis for a decision on whether to propose adding multiple 
sclerosis to the List.

D. Administrator's Determination on Petition 013

    The Administrator has established a policy for evaluating whether 
to propose the addition of non-cancer health conditions to the List of 
WTC-Related Health Conditions.\16\ Petition 013 requested the addition 
of ``relapsing remitting multiple sclerosis (autoimmune)'' to the List. 
The Administrator previously reviewed the category of ``autoimmune 
diseases,'' which includes multiple sclerosis, for Petitions 007, 008, 
009, and 011. Neither the references included in Petition 013 nor the 
studies found in the literature review conducted by the Science Team 
presented evidence of a causal association between 9/11 exposures and

[[Page 60332]]

autoimmune diseases, including multiple sclerosis.
---------------------------------------------------------------------------

    \16\ Supra note 6.
---------------------------------------------------------------------------

    The Administrator initially reviewed the findings presented in the 
2015 Webber et al. study in response to Petition 007, which also 
requested the addition of autoimmune diseases, including rheumatoid 
arthritis and connective tissue diseases. In that review, due to 
limitations in the 2015 Webber et al. study, the Administrator 
determined that insufficient evidence existed to take any of the 
following actions: Propose the addition of autoimmune diseases to the 
List (pursuant to PHS Act, sec. 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, sec. 
3312(a)(6)(B)(iii) and 42 CFR 88.17(a)(2)(iii)); or request a 
recommendation from the STAC (pursuant to PHS Act, sec. 
3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)). The 2015 Webber et al. 
study was also presented as evidence to support the Petition 008 
request for autoimmune disorders, specifically encephalitis of the 
brain, the Petition 009 request for autoimmune disorders, including 
multiple sclerosis, as well as the Petition 011 request for autoimmune 
disorders, including lupus and rheumatoid arthritis. The 2016 Webber et 
al. study was also presented as evidence to support Petition 011. As 
concluded in the April 2016 FRN for Petition 011, the two Webber et al. 
studies, taken together, while meeting the relevance threshold of being 
published, peer-reviewed epidemiologic studies of autoimmune diseases 
in 9/11-exposed populations, were found to exhibit significant 
limitations and were thus insufficient to provide a potential basis for 
a decision on whether to propose adding the requested health conditions 
to the List.\17\
---------------------------------------------------------------------------

    \17\ 81 FR 24047 at 24050.
---------------------------------------------------------------------------

    Finding no additional relevant studies with regard to Petition 013, 
the Administrator has accordingly determined that insufficient evidence 
exists to take further action at this time, including either proposing 
the addition of autoimmune diseases, including multiple sclerosis, to 
the List (pursuant to PHS Act, sec. 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, sec. 
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, sec. 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 013 
to add ``relapsing remitting multiple sclerosis (autoimmune)'' to the 
List of WTC-Related Health Conditions is denied.
    The Administrator will continue to monitor the scientific 
literature for publication of the results of the ongoing WTC Health 
Registry study discussed above (reference 5 in the petition) and any 
other studies that address autoimmune diseases among 9/11-exposed 
populations.

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. 2016-21070 Filed 8-31-16; 8:45 am]
 BILLING CODE 4163-18-P



                                                                          Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Proposed Rules                                                60329

                                                      and lead-based paint management                         ACTION:   Proposed rule.                              (Mail code OEP05–2), Boston, MA
                                                      requirements under this part throughout                                                                       02109–3912, telephone number (617)
                                                      the 12 months preceding the date the                    SUMMARY:    The Environmental Protection              918–1684, fax number (617) 918–0684,
                                                      owner received the environmental                        Agency (EPA) is proposing to approve a                email simcox.alison@epa.gov.
                                                      investigation report pursuant to                        State Implementation Plan (SIP)                       SUPPLEMENTARY INFORMATION: In the
                                                      paragraph (a) of this section; and, in                  revision submitted by the State of                    Final Rules Section of this Federal
                                                      either case, the owner provided the                     Connecticut on November 19, 2012. We                  Register, EPA is approving the State’s
                                                      HUD field office, within 10 business                    propose to approve Connecticut’s                      SIP submittal as a direct final rule
                                                      days after receiving the notification of                request to remove two regulations from                without prior proposal because the
                                                      the elevated blood lead level,                          its SIP that regulate ‘‘open burning’’ and            Agency views this as a noncontroversial
                                                      documentation that it has conducted the                 ‘‘portable fuel container spillage                    submittal and anticipates no adverse
                                                      activities described in this paragraph                  control.’’ In place of the open burning               comments. A detailed rationale for the
                                                      (f)(4) of this section.                                 regulation, we propose to approve into                approval is set forth in the direct final
                                                         (g) HUD encourages the designated                    the Connecticut SIP a Connecticut                     rule. If no adverse comments are
                                                      party or the owner to evaluate for                      statute that controls open burning. We                received in response to this action rule,
                                                      sources of lead exposure in units other                 also propose to approve a definition of               no further activity is contemplated. If
                                                      than those covered by this subpart, and                 ‘‘brush,’’ which was included in a                    EPA receives adverse comments, the
                                                      to control such sources.                                December 15, 2015 SIP submittal by                    direct final rule will be withdrawn and
                                                         (h) Data collection and record keeping               Connecticut to meet infrastructure                    all public comments received will be
                                                      responsibilities. At least quarterly, the               requirements of the Clean Air Act for                 addressed in a subsequent final rule
                                                      designated party shall attempt to obtain                the 2012 fine particle (PM2.5) National               based on this proposed rule. EPA will
                                                      from the public health department(s)                    Ambient Air Quality Standards                         not institute a second comment period.
                                                      with area(s) of jurisdiction similar to                 (NAAQS). The requirements in the                      Any parties interested in commenting
                                                      that of the designated party the names                  Connecticut portable fuel container                   on this action should do so at this time.
                                                      and/or addresses of children of less than               regulation have been superseded by                    Please note that if EPA receives adverse
                                                      6 years of age with an identified                       federal portable fuel container                       comment on an amendment, paragraph,
                                                      elevated blood lead level. At least                     requirements. This action is being taken              or section of this rule and if that
                                                      quarterly, the designated party shall also              in accordance with the Clean Air Act.                 provision may be severed from the
                                                      report an updated list of the addresses                 DATES: Written comments must be                       remainder of the rule, EPA may adopt
                                                      of units receiving assistance under a                   received on or before October 3, 2016.                as final those provisions of the rule that
                                                      tenant-based rental assistance program                  ADDRESSES: Submit your comments,                      are not the subject of an adverse
                                                      to the same public health department(s),                identified by Docket ID No. EPA–R01–                  comment.
                                                      except that the report(s) to the public                 OAR–2015–0471 by one of the following                    For additional information, see the
                                                      health department(s) is not required if                 methods:                                              direct final rule which is located in the
                                                      the health department states that it does                  1. http://www.regulations.gov: Follow              Rules Section of this Federal Register.
                                                      not wish to receive such report. If it                  the online instructions for submitting                  Dated: February 4, 2016.
                                                      obtains names and addresses of elevated                 comments.
                                                                                                                                                                    H. Curtis Spalding,
                                                      blood lead level children from the                         2. Email: arnold.anne@epa.gov.
                                                                                                                 3. Mail: ‘‘EPA–R01–OAR–2015–                       Regional Administrator, EPA New England.
                                                      public health department(s), the
                                                      designated party shall match                            0471,’’ Anne Arnold, U.S.                             [FR Doc. 2016–21011 Filed 8–31–16; 8:45 am]
                                                      information on cases of elevated blood                  Environmental Protection Agency, EPA                  BILLING CODE 6560–50–P

                                                      lead levels with the names and                          New England Regional Office, 5 Post
                                                      addresses of families receiving tenant-                 Office Square—Suite 100, (Mail code
                                                      based rental assistance, unless the                     OEP05–2), Boston, MA 02109–3912.                      DEPARTMENT OF HEALTH AND
                                                      public health department performs such                     4. Hand Delivery or Courier. Deliver               HUMAN SERVICES
                                                      a matching procedure. If a match occurs,                your comments to: Anne Arnold,
                                                      the designated party shall carry out the                Manager, Air Quality Planning Unit,                   42 CFR Part 88
                                                      requirements of this section.                           Office of Ecosystem Protection, U.S.                  [NIOSH Docket 094]
                                                        Dated: August 26, 2016.
                                                                                                              Environmental Protection Agency, EPA
                                                                                                              New England Regional Office, 5 Post                   World Trade Center Health Program;
                                                      Michelle Miller,
                                                                                                              Office Square—Suite 100, (Mail code                   Petition 013—Autoimmune Disease;
                                                      Deputy Director, Office of Healthy Homes and            OEP05–2), Boston, MA 02109–3912.                      Finding of Insufficient Evidence
                                                      Lead Hazard Control.
                                                                                                              Such deliveries are only accepted
                                                      [FR Doc. 2016–20955 Filed 8–31–16; 8:45 am]
                                                                                                              during the Regional Office’s normal                   AGENCY:  Centers for Disease Control and
                                                      BILLING CODE 4210–67–P                                  hours of operation. The Regional                      Prevention, HHS.
                                                                                                              Office’s official hours of business are               ACTION: Denial of petition for addition of
                                                                                                              Monday through Friday, 8:30 a.m. to                   a health condition.
                                                      ENVIRONMENTAL PROTECTION                                4:30 p.m., excluding legal holidays.                  SUMMARY:   On April 4, 2016, the
                                                      AGENCY                                                     Please see the direct final rule which             Administrator of the World Trade
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                                                                              is located in the Rules Section of this               Center (WTC) Health Program received
                                                      40 CFR Part 52                                          Federal Register for detailed                         a petition (Petition 013) to add
                                                      [EPA–R01–OAR–2015–0471; A–1–FRL–                        instructions on how to submit                         ‘‘relapsing remitting multiple sclerosis
                                                      9943–04–Region 1]                                       comments.                                             (autoimmune)’’ to the List of WTC-
                                                      Air Plan Approval; Connecticut; Open                    FOR FURTHER INFORMATION CONTACT:                      Related Health Conditions (List). Upon
                                                      Burning and Portable Fuel Containers                    Alison C. Simcox, Air Quality Planning                reviewing the information provided by
                                                                                                              Unit, U.S. Environmental Protection                   the petitioner, the Administrator has
                                                      AGENCY: Environmental Protection                        Agency, EPA New England Regional                      determined that Petition 013 is not
                                                      Agency (EPA).                                           Office, 5 Post Office Square—Suite 100,               substantially different from Petitions


                                                 VerDate Sep<11>2014   16:57 Aug 31, 2016   Jkt 238001   PO 00000   Frm 00033   Fmt 4702   Sfmt 4702   E:\FR\FM\01SEP1.SGM   01SEP1


                                                      60330                Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Proposed Rules

                                                      007, 008, 009, and 011, which also                      or adult daycare in the New York City                 autoimmune disease of multiple
                                                      requested the addition of autoimmune                    disaster area (survivors).                            sclerosis’’ in the petition narrative and
                                                      diseases, including various subtypes.                     All references to the Administrator of              used a study of autoimmune diseases
                                                      The Administrator recently published                    the WTC Health Program                                among WTC responders to provide the
                                                      responses to the four previous petitions                (Administrator) in this notice mean the               medical basis for the petition,3 the
                                                      in the Federal Register and has                         Director of the National Institute for                Administrator determined that the
                                                      determined that Petition 013 does not                   Occupational Safety and Health                        petitioned health condition is
                                                      provide additional evidence of a causal                 (NIOSH) or his or her designee.                       ‘‘autoimmune diseases, including
                                                      relationship between 9/11 exposures                       Pursuant to section 3312(a)(6)(B) of                multiple sclerosis.’’
                                                      and autoimmune diseases, including                      the PHS Act, interested parties may                      This is the fifth petition to the
                                                      multiple sclerosis. Accordingly, the                    petition the Administrator to add a                   Administrator requesting the addition of
                                                      Administrator finds that insufficient                   health condition to the List in 42 CFR                autoimmune diseases, including various
                                                      evidence exists to request a                            88.1. Within 90 days after receipt of a               subtypes, to the List; each of the first
                                                      recommendation of the WTC Health                        petition to add a condition to the List,              four autoimmune disease petitions were
                                                      Program Scientific/Technical Advisory                   the Administrator must take one of the                denied due to insufficient evidence, as
                                                      Committee (STAC), to publish a                          following four actions described in                   described in respective Federal Register
                                                      proposed rule, or to publish a                          section 3312(a)(6)(B) and 42 CFR 88.17:               notices (FRNs).4 The medical basis for a
                                                      determination not to publish a proposed                 (1) Request a recommendation of the                   potential addition to the List may be
                                                      rule.                                                   STAC; (2) publish a proposed rule in the              demonstrated by reference to a peer-
                                                                                                              Federal Register to add such health                   reviewed, published, epidemiologic
                                                      DATES:  The Administrator of the WTC                    condition; (3) publish in the Federal                 study about the health condition among
                                                      Health Program is denying this petition                 Register the Administrator’s                          9/11-exposed populations or to clinical
                                                      for the addition of a health condition as               determination not to publish such a                   case reports of health conditions in
                                                      of September 1, 2016.                                   proposed rule and the basis for such                  WTC responders or survivors.5 In
                                                      FOR FURTHER INFORMATION CONTACT:                        determination; or (4) publish in the                  accordance with WTC Health Program
                                                      Rachel Weiss, Program Analyst, 1090                     Federal Register a determination that                 policy, the Science Team reviews
                                                      Tusculum Avenue, MS: C–46,                              insufficient evidence exists to take                  references for relevance, and relevant
                                                      Cincinnati, OH 45226; telephone (855)                   action under (1) through (3) above.                   studies are further reviewed for quality
                                                      818–1629 (this is a toll-free number);                  However, in accordance with 42 CFR                    and quantity.6 The current petition,
                                                      email NIOSHregs@cdc.gov.                                88.17(a)(4), the Administrator is                     Petition 013, presented five references
                                                                                                              required to consider a new petition for               to support the request to add ‘‘relapsing
                                                      SUPPLEMENTARY INFORMATION:                                                                                    remitting multiple sclerosis
                                                                                                              a previously-evaluated health condition
                                                      Table of Contents                                       determined not to qualify for addition to             (autoimmune)’’ to the List.
                                                                                                              the List only if the new petition presents               Petition 013 references 1, 2, and 4 are
                                                      A. WTC Health Program Statutory Authority                                                                     links to the same newspaper article
                                                      B. Approval To Submit Document to the                   a new medical basis—evidence not
                                                                                                              previously reviewed by the                            announcing the online publication of a
                                                          Office of the Federal Register
                                                                                                              Administrator—for the association                     study published in 2015.7 Petition 013
                                                      C. Petition 013
                                                      D. Administrator’s Determination on Petition            between 9/11 exposures and the                          3 Id.
                                                          013                                                 condition to be added.                                   4 ‘‘World Trade Center Health Program; Petition

                                                      A. WTC Health Program Statutory                         B. Approval To Submit Document to the                 007—Autoimmune Diseases; Finding of Insufficient
                                                      Authority                                                                                                     Evidence,’’ 80 FR 32333 (June 8, 2015); ‘‘World
                                                                                                              Office of the Federal Register                        Trade Center Health Program; Petition 008—
                                                         Title I of the James Zadroga 9/11                      The Secretary, HHS, or her designee,                Autoimmune Diseases; Finding of Insufficient
                                                                                                                                                                    Evidence,’’ 80 FR 39720 (July 10, 2015); ‘‘World
                                                      Health and Compensation Act of 2010                     the Director, Centers for Disease Control             Trade Center Health Program; Petition 009—
                                                      (Pub. L. 111–347, as amended by Pub.                    and Prevention (CDC) and                              Autoimmune Diseases; Finding of Insufficient
                                                      L. 114–113), added Title XXXIII to the                  Administrator, Agency for Toxic                       Evidence,’’ 80 FR 65980 (Oct. 28, 2015); and
                                                                                                              Substances and Disease Registry                       ‘‘World Trade Center Health Program; Petition
                                                      Public Health Service Act (PHS Act),1                                                                         011—Autoimmune Diseases; Finding of Insufficient
                                                      establishing the WTC Health Program                     (ATSDR), authorized the undersigned,                  Evidence,’’ 81 FR 24047 (April 25, 2016).
                                                      within the Department of Health and                     the Administrator of the WTC Health                      5 See John Howard, Administrator of the WTC

                                                      Human Services (HHS). The WTC                           Program, to sign and submit the                       Health Program, Policy and Procedures for
                                                      Health Program provides medical                         document to the Office of the Federal                 Handling Submissions and Petitions to Add a
                                                                                                                                                                    Health Condition to the List of WTC-Related Health
                                                      monitoring and treatment benefits to                    Register for publication as an official               Conditions, May 14, 2014, http://www.cdc.gov/wtc/
                                                      eligible firefighters and related                       document of the WTC Health Program.                   pdfs/WTCHPPPPetitionHandlingProcedures14May
                                                      personnel, law enforcement officers,                    Thomas R. Frieden, M.D., M.P.H.,                      2014.pdf.
                                                      and rescue, recovery, and cleanup                       Director, CDC, and Administrator,                        6 Information is determined to be relevant if it is

                                                                                                              ATSDR, approved this document for                     presented in peer-reviewed, published,
                                                      workers who responded to the                                                                                  epidemiologic studies of the health condition in 9/
                                                      September 11, 2001, terrorist attacks in                publication on August 24, 2016.                       11-exposed populations. John Howard,
                                                      New York City, at the Pentagon, and in                                                                        Administrator of the WTC Health Program, Policy
                                                                                                              C. Petition 013                                       and Procedures for Adding Non-Cancer Conditions
                                                      Shanksville, Pennsylvania (responders),
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                                                                                 On April 4, 2016, the Administrator                to the List of WTC-Related Health Conditions, May
                                                      and to eligible persons who were                                                                              11, 2016, http://www.cdc.gov/wtc/pdfs/WTCHP_PP
                                                                                                              received a petition from a responder in               _Adding_NonCancer_Conditions_Revision_11_
                                                      present in the dust or dust cloud on
                                                                                                              the WTC Health Program to add                         May_2016.pdf.
                                                      September 11, 2001 or who worked,
                                                                                                              ‘‘relapsing remitting multiple sclerosis                 7 The article, by Amy Norton, is published in
                                                      resided, or attended school, childcare,
                                                                                                              (autoimmune)’’ to the List (Petition                  reference 1, New Health Worry for 9/11 Recovery
                                                                                                              013).2 Because the petitioner identified              Workers, HealthDay, March 19, 2015, in
                                                        1 Title XXXIII of the PHS Act is codified at 42                                                             www.cbsnews.com/news/ground-zero-workers-at-
                                                      U.S.C. 300mm to 300mm-61. Those portions of the         the requested health condition as ‘‘the               risk-of-autoimmune-diseases; reference 2, ‘Ground
                                                      Zadroga Act found in Titles II and III of Public Law                                                          Zero’ Workers at Risk of Autoimmune Diseases:
                                                      111–347 do not pertain to the WTC Health Program          2 See Petition 013, WTC Health Program: Petitions   Study, HealthDay, March 19, 2015, in http://
                                                      and are codified elsewhere.                             Received, http://www.cdc.gov/wtc/received.html.       www.medicinenet.com/script/main/



                                                 VerDate Sep<11>2014   16:57 Aug 31, 2016   Jkt 238001   PO 00000   Frm 00034   Fmt 4702   Sfmt 4702   E:\FR\FM\01SEP1.SGM    01SEP1


                                                                            Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Proposed Rules                                         60331

                                                      reference 3 is a different newspaper                      9/11-related exposures and systemic                   workers included in the 2015 study to
                                                      article announcing the online                             autoimmune diseases. It was found to be               estimate the incidence of systemic
                                                      publication of the same study.8 These                     a published, peer-reviewed                            autoimmune diseases in the cohort of
                                                      four references identify a 2015 study by                  epidemiologic study of autoimmune                     FDNY rescue/recovery workers and to
                                                      Webber et al., a peer-reviewed,                           diseases in the 9/11 population, and                  compare the FDNY incidence rates to
                                                      published epidemiologic study of                          therefore deemed relevant. However, the               demographically similar men and other
                                                      autoimmune diseases among 9/11-                           study was found to exhibit substantial                published rates. This additional
                                                      exposed responders and survivors, titled                  limitations, and it was ultimately                    reference, the 2016 Webber et al. study,
                                                      ‘‘Nested Case-Control Study of Selected                   concluded not to have the potential to                was also identified as relevant in the
                                                      Systemic Autoimmune Diseases in                           form the basis for a decision on whether              literature search for Petition 011. As a
                                                      World Trade Center Rescue/Recovery                        to propose adding autoimmune diseases                 result, it was further reviewed in the
                                                      Workers.’’ 9 The 2015 Webber et al.                       to the List of WTC-Related Health                     April 2016 FRN for Petition 011 and,
                                                      study has already been evaluated by the                   Conditions.11                                         along with the 2015 Webber et al. study,
                                                      Administrator in consideration of the                        In addition to a review of the studies             evaluated for quantity and quality to
                                                      other four autoimmune disease                             presented in Petition 013, the WTC                    provide a sufficient basis for deciding
                                                      petitions, and is discussed below.                        Health Program Science Team                           whether to propose an addition to the
                                                         The fifth reference provided in                        conducted a review of the scientific                  List. Significant limitations, discussed
                                                      Petition 013 does not specifically                        literature to determine if the available              in the April 2016 FRN for Petition 011,
                                                      identify a peer-reviewed, published                       scientific information has the potential              led the WTC Health Program to
                                                      epidemiologic study of the health                         to provide a basis for a decision on                  conclude that the 2015 Webber et al.,
                                                      condition among 9/11-exposed                              whether to add the condition to the List.             and the 2016 Webber et al. study
                                                      populations, nor is it a clinical case                    A previously conducted literature                     together do not have the potential to
                                                      report of the health condition in WTC                     review for autoimmune diseases in                     provide a basis for a decision on
                                                      responders or survivors. Petition 013                     response to Petition 007 12 included all              whether to propose adding autoimmune
                                                      reference 5 is a link to the proceedings                  of the autoimmune conditions in the                   diseases to the List.
                                                      of a research meeting conducted by the                    2015 Webber et al. study.13 In reviewing                 All of the references and potential
                                                      WTC Health Program in 2014.10 Two                         Petition 013, the Science Team                        medical bases presented in Petition 013
                                                      abstracts found in the proceedings                        conducted a search to update the results              were previously identified and assessed
                                                      address the topic of autoimmune                           of the previous literature review for all             in Petition 011; as discussed above,
                                                      disease among the 9/11 population—                        of the types of autoimmune diseases
                                                                                                                                                                      these medical bases had significant
                                                      ‘‘Autoimmune Disease among WTCHR                          identified in the 2015 Webber et al.
                                                                                                                                                                      limitations that prevented them from
                                                      [World Trade Center Health Registry]                      study, and also conducted a separate
                                                                                                                                                                      having the potential to provide a basis
                                                      Registrants: Survey Design and                            search for published, peer-reviewed
                                                                                                                                                                      to propose adding autoimmune diseases
                                                      Preliminary Response Rates,’’ and                         studies of multiple sclerosis in 9/11
                                                                                                                                                                      to the List. The Science Team did not
                                                      ‘‘Post-9/11 Incidence of Systemic                         populations.14
                                                                                                                   The Science Team identified five                   find any information during their
                                                      Autoimmune Diseases in the FDNY                                                                                 review of Petition 013 which would
                                                                                                                additional references to review for
                                                      Cohort.’’ The former abstract references                                                                        alter the assessment of the previously
                                                                                                                relevance. Of the five additional
                                                      an unpublished study; because                                                                                   reviewed studies. Moreover, none of the
                                                                                                                references, only one study, published in
                                                      unpublished studies do not meet the                                                                             studies identified, including the 2015
                                                                                                                2016 by Webber et al.,15 was found to
                                                      Program’s standard for relevance, it was                                                                        and 2016 Webber et al. studies, include
                                                                                                                be a relevant, published, peer-reviewed
                                                      not further considered. The latter                                                                              multiple sclerosis. Thus, no evidence
                                                                                                                study of autoimmune diseases in 9/11-
                                                      abstract describes a study that resulted                                                                        was found specific to multiple sclerosis
                                                                                                                exposed populations. No published,
                                                      in the 2015 Webber et al. publication                                                                           which would have the potential to form
                                                                                                                peer-reviewed epidemiologic studies of
                                                      discussed in this action and reviewed in                                                                        the basis for a decision on whether to
                                                                                                                multiple sclerosis in 9/11-exposed
                                                      full in the April 2016 FRN for Petition                                                                         propose adding multiple sclerosis to the
                                                                                                                populations were identified in the
                                                      011.                                                                                                            List.
                                                                                                                literature search.
                                                         As discussed in the April 2016 FRN
                                                                                                                   The 2016 Webber et al. study is a                  D. Administrator’s Determination on
                                                      finding of insufficient evidence for
                                                                                                                follow-up to the 2015 Webber et al.                   Petition 013
                                                      Petition 011, the 2015 Webber et al.
                                                                                                                study discussed above. The 2016
                                                      study looked at the association between                                                                           The Administrator has established a
                                                                                                                Webber et al. study looked at the same
                                                                                                                cohort of FDNY rescue/recovery                        policy for evaluating whether to propose
                                                      art.asp?articlekey=187534; and reference 4, ‘Ground                                                             the addition of non-cancer health
                                                      Zero’ Workers at Risk of Autoimmune Diseases:
                                                      Study, HealthDay, March 19, 2015, https://                  11 81 FR 24047 at 24049.                            conditions to the List of WTC-Related
                                                      consumer.healthday.com/senior-citizen-                      12 See 80 FR 32333 at 32334.                        Health Conditions.16 Petition 013
                                                      information-31/misc-arthritis-news-41/ground-zero-          13 Rheumatoid arthritis; spondyloarthritis;         requested the addition of ‘‘relapsing
                                                      workers-at-risk-of-autoimmune-diseases-study-             inflammatory myositis (polymyositis and               remitting multiple sclerosis
                                                      697581.html. The study announced in the Norton            dermatomyositis); systemic lupus erythematosus;
                                                      article is the 2015 study by Webber et al., cited infra
                                                                                                                                                                      (autoimmune)’’ to the List. The
                                                                                                                systemic sclerosis (scleroderma); Sjogren’s
                                                      note 9.                                                   syndrome; antiphospholipid syndrome;                  Administrator previously reviewed the
                                                        8 Nancy Walsh, Autoimmunity Rising in 9/11              granulomatosis with polyangiitis (Wegener’s); and     category of ‘‘autoimmune diseases,’’
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      Workers, MedPage Today, March 19, 2015, http://           eosinophilic granulomatosis with polyangiitis         which includes multiple sclerosis, for
                                                      www.medpagetoday.com/Rheumatology/General                 (Churg-Strauss).                                      Petitions 007, 008, 009, and 011. Neither
                                                      Rheumatology/50548.                                         14 Databases searched include: CINAHL, Embase,
                                                        9 Mayris Webber, William Moir, Rachel Zeig-             NIOSHTIC–2, PsycINFO, PubMed, Scopus,
                                                                                                                                                                      the references included in Petition 013
                                                      Owens, et al., Nested Case-Control Study of               Toxicology Abstracts, and TOXLINE.                    nor the studies found in the literature
                                                      Selected Systemic Autoimmune Diseases in World              15 Mayris Webber, William Moir, Cynthia             review conducted by the Science Team
                                                      Trade Center Rescue/Recovery Workers, Arthritis           Crowson, et al., Post-September 11, 2001, Incidence   presented evidence of a causal
                                                      Rheumatol 2015;67(5):1369–1376.                           of Systemic Autoimmune Diseases in World Trade
                                                        10 WTC Health Program, Research Meeting
                                                                                                                                                                      association between 9/11 exposures and
                                                                                                                Center-Exposed Firefighters and Emergency
                                                      Proceedings, June 17–18, 2014, www.cdc.gov/wtc/           Medical Service Workers, Mayo Clin Proc
                                                      proceedings.html.                                         2016;91(1):23–32.                                      16 Supra   note 6.



                                                 VerDate Sep<11>2014    16:57 Aug 31, 2016   Jkt 238001   PO 00000   Frm 00035   Fmt 4702   Sfmt 4702   E:\FR\FM\01SEP1.SGM   01SEP1


                                                      60332                 Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Proposed Rules

                                                      autoimmune diseases, including                            3312(a)(6)(B)(i) and 42 CFR                           comment on amendments to an
                                                      multiple sclerosis.                                       88.17(a)(2)(i)) is unwarranted.                       information collection. See the
                                                         The Administrator initially reviewed                      For the reasons discussed above, the               Paperwork Reduction Act section under
                                                      the findings presented in the 2015                        request made in Petition 013 to add                   Rulemaking Analyses and Notices
                                                      Webber et al. study in response to                        ‘‘relapsing remitting multiple sclerosis              below. Please submit all comments
                                                      Petition 007, which also requested the                    (autoimmune)’’ to the List of WTC-                    relating to the information collection
                                                      addition of autoimmune diseases,                          Related Health Conditions is denied.                  requirements to NHTSA and to the
                                                      including rheumatoid arthritis and                           The Administrator will continue to                 Office of Management and Budget
                                                      connective tissue diseases. In that                       monitor the scientific literature for                 (OMB) at the address listed in the
                                                      review, due to limitations in the 2015                    publication of the results of the ongoing             ADDRESSES section on or before October
                                                      Webber et al. study, the Administrator                    WTC Health Registry study discussed                   31, 2016. Comments to OMB are most
                                                      determined that insufficient evidence                     above (reference 5 in the petition) and               useful if submitted within 30 days of
                                                      existed to take any of the following                      any other studies that address                        publication.
                                                      actions: Propose the addition of                          autoimmune diseases among 9/11-
                                                                                                                                                                      ADDRESSES:   You may submit comments
                                                      autoimmune diseases to the List                           exposed populations.
                                                                                                                                                                      by any of the following methods:
                                                      (pursuant to PHS Act, sec.                                John Howard,                                             • Internet: Go to http://
                                                      3312(a)(6)(B)(ii) and 42 CFR                              Administrator, World Trade Center Health              www.regulations.gov and follow the
                                                      88.17(a)(2)(ii)); publish a determination                 Program and Director, National Institute for          online instructions for submitting
                                                      not to publish a proposed rule in the                     Occupational Safety and Health, Centers for           comments.
                                                      Federal Register (pursuant to PHS Act,                    Disease Control and Prevention, Department               • Mail: Docket Management Facility,
                                                      sec. 3312(a)(6)(B)(iii) and 42 CFR                        of Health and Human Services.                         M–30, U.S. Department of
                                                      88.17(a)(2)(iii)); or request a                           [FR Doc. 2016–21070 Filed 8–31–16; 8:45 am]           Transportation, 1200 New Jersey
                                                      recommendation from the STAC                              BILLING CODE 4163–18–P                                Avenue SE., West Building, Room W12–
                                                      (pursuant to PHS Act, sec.                                                                                      140, Washington, DC 20590.
                                                      3312(a)(6)(B)(i) and 42 CFR                                                                                        • Hand Delivery or Courier: U.S.
                                                      88.17(a)(2)(i)). The 2015 Webber et al.                   DEPARTMENT OF TRANSPORTATION                          Department of Transportation, 1200
                                                      study was also presented as evidence to                                                                         New Jersey Avenue SE., West Building,
                                                      support the Petition 008 request for                      National Highway Traffic Safety                       Room W12–140, Washington, DC 20590
                                                      autoimmune disorders, specifically                        Administration                                        between 9 a.m. and 5 p.m. Eastern Time,
                                                      encephalitis of the brain, the Petition                                                                         Monday through Friday, except Federal
                                                      009 request for autoimmune disorders,                     49 CFR Part 577                                       holidays.
                                                      including multiple sclerosis, as well as                                                                           • Facsimile: (202) 493–2251.
                                                                                                                [Docket No. NHTSA–2016–0001]
                                                      the Petition 011 request for autoimmune                                                                            Regardless of how you submit your
                                                      disorders, including lupus and                            RIN 2127–AL66                                         comments, please include the docket
                                                      rheumatoid arthritis. The 2016 Webber                                                                           number of this document.
                                                      et al. study was also presented as                        Update Means of Providing Recall
                                                                                                                                                                         You may also call the Docket at (202)
                                                      evidence to support Petition 011. As                      Notification
                                                                                                                                                                      366–9322.
                                                      concluded in the April 2016 FRN for                       AGENCY: National Highway Traffic                         Note that all comments received will
                                                      Petition 011, the two Webber et al.                       Safety Administration (NHTSA),                        be posted without change to http://
                                                      studies, taken together, while meeting                    Department of Transportation (DOT).                   www.regulations.gov, including any
                                                      the relevance threshold of being                          ACTION: Notice of proposed rulemaking                 personal information provided. Please
                                                      published, peer-reviewed epidemiologic                    (NPRM).                                               see the Privacy Act discussion below.
                                                      studies of autoimmune diseases in 9/11-                                                                            Privacy Act: Anyone is able to search
                                                      exposed populations, were found to                        SUMMARY:   NHTSA proposes to amend                    the electronic form of all comments
                                                      exhibit significant limitations and were                  the means of recall notification to                   name of the individual submitting the
                                                      thus insufficient to provide a potential                  owners and purchasers required under                  comment (or signing the comment, if
                                                      basis for a decision on whether to                        the Safety Act to be in an electronic                 submitted on behalf of an association,
                                                      propose adding the requested health                       manner, in addition to first class mail,              business, labor union, etc.). You may
                                                      conditions to the List.17                                 in accordance with Section 30130 of the               review DOT’s complete Privacy Act
                                                         Finding no additional relevant studies                 Moving Ahead for Progress in the 21st                 Statement in the Federal Register
                                                      with regard to Petition 013, the                          Century Act (MAP–21) and Section                      published on April 11, 2000 (65 FR
                                                      Administrator has accordingly                             24104 of the Fixing America’s Surface                 19476 at 19477–78).
                                                      determined that insufficient evidence                     Transportation Act (FAST Act).                        FOR FURTHER INFORMATION CONTACT: For
                                                      exists to take further action at this time,               Through this proposed rule, NHTSA                     substantive issues: Jennifer Timian,
                                                      including either proposing the addition                   also seeks to improve the efficacy of                 Office of Defects Investigation, National
                                                      of autoimmune diseases, including                         recalls by requiring manufacturers to                 Highway Traffic Safety Administration,
                                                      multiple sclerosis, to the List (pursuant                 send additional notifications of defects              at (202) 366–4000. For legal issues:
                                                      to PHS Act, sec. 3312(a)(6)(B)(ii) and 42                 or noncompliance with applicable                      Justine Casselle, Office of the Chief
                                                      CFR 88.17(a)(2)(ii)) or publishing a                      Federal Motor Vehicle Safety Standards                Counsel, National Highway Traffic
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      determination not to publish a proposed                   (FMVSS) if a second notification by the               Safety Administration, at (202) 366–
                                                      rule in the Federal Register (pursuant to                 manufacturer does not result in an                    2992.
                                                      PHS Act, sec. 3312(a)(6)(B)(iii) and 42                   adequate number of motor vehicles or
                                                      CFR 88.17(a)(2)(iii)). The Administrator                  replacement equipment being returned                  SUPPLEMENTARY INFORMATION:
                                                      has also determined that requesting a                     for remedy.                                           I. Executive Summary
                                                                                                                                                                      II. Notification Requirements Before and
                                                      recommendation from the STAC                              DATES: Comments must be received on                         After MAP–21 and FAST Act
                                                      (pursuant to PHS Act, sec.                                or before October 31, 2016. In                        III. NHTSA’s Proposed Amendment To
                                                                                                                compliance with the Paperwork                               Require Notification to Owners and
                                                        17 81   FR 24047 at 24050.                              Reduction Act, NHTSA is also seeking                        Purchasers by Electronic Means in



                                                 VerDate Sep<11>2014     16:57 Aug 31, 2016   Jkt 238001   PO 00000   Frm 00036   Fmt 4702   Sfmt 4702   E:\FR\FM\01SEP1.SGM   01SEP1



Document Created: 2018-02-09 11:57:16
Document Modified: 2018-02-09 11:57:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionDenial of petition for addition of a health condition.
DatesThe Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of September 1, 2016.
ContactRachel 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 Citation81 FR 60329 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR