World Trade Center Health Program; Petition 013-Autoimmune Disease; Finding of Insufficient Evidence, 60329-60332 [2016-21070]

Download as PDF Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Proposed Rules and lead-based paint management requirements under this part throughout the 12 months preceding the date the owner received the environmental investigation report pursuant to paragraph (a) of this section; and, in either case, the owner provided the HUD field office, within 10 business days after receiving the notification of the elevated blood lead level, documentation that it has conducted the activities described in this paragraph (f)(4) of this section. (g) HUD encourages the designated party or the owner to evaluate for sources of lead exposure in units other than those covered by this subpart, and to control such sources. (h) Data collection and record keeping responsibilities. At least quarterly, the designated party shall attempt to obtain from the public health department(s) with area(s) of jurisdiction similar to that of the designated party the names and/or addresses of children of less than 6 years of age with an identified elevated blood lead level. At least quarterly, the designated party shall also report an updated list of the addresses of units receiving assistance under a tenant-based rental assistance program to the same public health department(s), except that the report(s) to the public health department(s) is not required if the health department states that it does not wish to receive such report. If it obtains names and addresses of elevated blood lead level children from the public health department(s), the designated party shall match information on cases of elevated blood lead levels with the names and addresses of families receiving tenantbased rental assistance, unless the public health department performs such a matching procedure. If a match occurs, the designated party shall carry out the requirements of this section. Dated: August 26, 2016. Michelle Miller, Deputy Director, Office of Healthy Homes and Lead Hazard Control. [FR Doc. 2016–20955 Filed 8–31–16; 8:45 am] asabaliauskas on DSK3SPTVN1PROD with PROPOSALS BILLING CODE 4210–67–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R01–OAR–2015–0471; A–1–FRL– 9943–04–Region 1] Air Plan Approval; Connecticut; Open Burning and Portable Fuel Containers Environmental Protection Agency (EPA). AGENCY: VerDate Sep<11>2014 16:57 Aug 31, 2016 Jkt 238001 ACTION: Proposed rule. The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Connecticut on November 19, 2012. We propose to approve Connecticut’s request to remove two regulations from its SIP that regulate ‘‘open burning’’ and ‘‘portable fuel container spillage control.’’ In place of the open burning regulation, we propose to approve into the Connecticut SIP a Connecticut statute that controls open burning. We also propose to approve a definition of ‘‘brush,’’ which was included in a December 15, 2015 SIP submittal by Connecticut to meet infrastructure requirements of the Clean Air Act for the 2012 fine particle (PM2.5) National Ambient Air Quality Standards (NAAQS). The requirements in the Connecticut portable fuel container regulation have been superseded by federal portable fuel container requirements. This action is being taken in accordance with the Clean Air Act. DATES: Written comments must be received on or before October 3, 2016. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–R01– OAR–2015–0471 by one of the following methods: 1. http://www.regulations.gov: Follow the online instructions for submitting comments. 2. Email: arnold.anne@epa.gov. 3. Mail: ‘‘EPA–R01–OAR–2015– 0471,’’ Anne Arnold, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05–2), Boston, MA 02109–3912. 4. Hand Delivery or Courier. Deliver your comments to: Anne Arnold, Manager, Air Quality Planning Unit, Office of Ecosystem Protection, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05–2), Boston, MA 02109–3912. Such deliveries are only accepted during the Regional Office’s normal hours of operation. The Regional Office’s official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays. Please see the direct final rule which is located in the Rules Section of this Federal Register for detailed instructions on how to submit comments. SUMMARY: FOR FURTHER INFORMATION CONTACT: Alison C. Simcox, Air Quality Planning Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, PO 00000 Frm 00033 Fmt 4702 Sfmt 4702 60329 (Mail code OEP05–2), Boston, MA 02109–3912, telephone number (617) 918–1684, fax number (617) 918–0684, email simcox.alison@epa.gov. SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal Register, EPA is approving the State’s SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules Section of this Federal Register. Dated: February 4, 2016. H. Curtis Spalding, Regional Administrator, EPA New England. [FR Doc. 2016–21011 Filed 8–31–16; 8:45 am] BILLING CODE 6560–50–P 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 Centers for Disease Control and Prevention, HHS. ACTION: Denial of petition for addition of a health condition. AGENCY: 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 WTCRelated Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 013 is not substantially different from Petitions SUMMARY: 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 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. The Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of September 1, 2016. DATES: FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090 Tusculum Avenue, MS: C–46, Cincinnati, OH 45226; telephone (855) 818–1629 (this is a toll-free number); email NIOSHregs@cdc.gov. SUPPLEMENTARY INFORMATION: Table of Contents A. WTC Health Program Statutory Authority B. Approval To Submit Document to the Office of the Federal Register C. Petition 013 D. Administrator’s Determination on Petition 013 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS A. WTC Health Program Statutory Authority Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111–347, 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, 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. VerDate Sep<11>2014 16:57 Aug 31, 2016 Jkt 238001 or adult daycare in the New York City disaster area (survivors). All references to the Administrator of the WTC Health Program (Administrator) in this notice mean the Director of the National Institute for Occupational Safety and Health (NIOSH) or his or her designee. Pursuant to section 3312(a)(6)(B) of the PHS Act, interested parties may petition the Administrator to add a health condition to the List in 42 CFR 88.1. Within 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 2 See Petition 013, WTC Health Program: Petitions Received, http://www.cdc.gov/wtc/received.html. PO 00000 Frm 00034 Fmt 4702 Sfmt 4702 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.’’ 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 peerreviewed, 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. 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 3 Id. 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/WTCHPPPPetitionHandlingProcedures14May 2014.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. 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-atrisk-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/ E:\FR\FM\01SEP1.SGM 01SEP1 Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 9/11exposed 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. 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. 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 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-citizeninformation-31/misc-arthritis-news-41/ground-zeroworkers-at-risk-of-autoimmune-diseases-study697581.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/General Rheumatology/50548. 9 Mayris Webber, William Moir, Rachel ZeigOwens, 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. 10 WTC Health Program, Research Meeting Proceedings, June 17–18, 2014, www.cdc.gov/wtc/ proceedings.html. VerDate Sep<11>2014 16:57 Aug 31, 2016 Jkt 238001 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 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 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 9/11exposed populations. No published, peer-reviewed epidemiologic studies of multiple sclerosis in 9/11-exposed populations were identified in the literature search. 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 11 81 FR 24047 at 24049. 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. 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. 12 See PO 00000 Frm 00035 Fmt 4702 Sfmt 4702 60331 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 16 Supra E:\FR\FM\01SEP1.SGM note 6. 01SEP1 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 60332 Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Proposed Rules autoimmune diseases, including multiple sclerosis. 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 9/11exposed 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 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. 17 81 FR 24047 at 24050. VerDate Sep<11>2014 16:57 Aug 31, 2016 Jkt 238001 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 WTCRelated 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 9/11exposed 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 DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 577 [Docket No. NHTSA–2016–0001] RIN 2127–AL66 Update Means of Providing Recall Notification National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). AGENCY: NHTSA proposes to amend the means of recall notification to owners and purchasers required under the Safety Act to be in an electronic manner, in addition to first class mail, in accordance with Section 30130 of the Moving Ahead for Progress in the 21st Century Act (MAP–21) and Section 24104 of the Fixing America’s Surface Transportation Act (FAST Act). Through this proposed rule, NHTSA also seeks to improve the efficacy of recalls by requiring manufacturers to send additional notifications of defects or noncompliance with applicable Federal Motor Vehicle Safety Standards (FMVSS) if a second notification by the manufacturer does not result in an adequate number of motor vehicles or replacement equipment being returned for remedy. DATES: Comments must be received on or before October 31, 2016. In compliance with the Paperwork Reduction Act, NHTSA is also seeking SUMMARY: PO 00000 Frm 00036 Fmt 4702 Sfmt 4702 comment on amendments to an information collection. See the Paperwork Reduction Act section under Rulemaking Analyses and Notices below. Please submit all comments relating to the information collection requirements to NHTSA and to the Office of Management and Budget (OMB) at the address listed in the ADDRESSES section on or before October 31, 2016. Comments to OMB are most useful if submitted within 30 days of publication. You may submit comments by any of the following methods: • Internet: Go to http:// www.regulations.gov and follow the online instructions for submitting comments. • Mail: Docket Management Facility, M–30, U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building, Room W12– 140, Washington, DC 20590. • Hand Delivery or Courier: U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building, Room W12–140, Washington, DC 20590 between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal holidays. • Facsimile: (202) 493–2251. Regardless of how you submit your comments, please include the docket number of this document. You may also call the Docket at (202) 366–9322. Note that all comments received will be posted without change to http:// www.regulations.gov, including any personal information provided. Please see the Privacy Act discussion below. Privacy Act: Anyone is able to search the electronic form of all comments name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT’s complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19476 at 19477–78). FOR FURTHER INFORMATION CONTACT: For substantive issues: Jennifer Timian, Office of Defects Investigation, National Highway Traffic Safety Administration, at (202) 366–4000. For legal issues: Justine Casselle, Office of the Chief Counsel, National Highway Traffic Safety Administration, at (202) 366– 2992. ADDRESSES: SUPPLEMENTARY INFORMATION: I. Executive Summary II. Notification Requirements Before and After MAP–21 and FAST Act III. NHTSA’s Proposed Amendment To Require Notification to Owners and Purchasers by Electronic Means in E:\FR\FM\01SEP1.SGM 01SEP1

Agencies

[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Proposed Rules]
[Pages 60329-60332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21070]


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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.

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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 NIOSHregs@cdc.gov.

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).
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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 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.''
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    \2\ See Petition 013, WTC Health Program: Petitions Received, 
http://www.cdc.gov/wtc/received.html.
    \3\ Id.
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    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.
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    \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.
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    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.
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    \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.
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    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.
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    \10\ WTC Health Program, Research Meeting Proceedings, June 17-
18, 2014, www.cdc.gov/wtc/proceedings.html.
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    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\
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    \11\ 81 FR 24047 at 24049.
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    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\
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    \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.
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    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.
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    \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.
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    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.
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    \16\ Supra note 6.
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    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\
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    \17\ 81 FR 24047 at 24050.
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    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