38938 Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. CDC–2011–0010] 

42 CFR Part 88 

RIN 0920–AA45 

World Trade Center Health Program 

Requirements for the Addition of New 

WTC-Related Health Conditions 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: Title I of the James Zadroga 

Health and Compensation Act of 2010 

amended the Public Health Service Act 

(PHS Act) to establish the World Trade 

Center (WTC) Health Program. Sections 

3311, 3312, and 3321 of Title XXXIII of 

the PHS Act require that the WTC 

Program Administrator develop 

regulations to implement portions of the 

WTC Health Program established within 

the Department of Health and Human 

Services (HHS). The WTC Health 

Program, which will be administered in 

part by the Director of the National 

Institute for Occupational Safety and 

Health (NIOSH), within the Centers for 

Disease Control and Prevention (CDC), 

will provide medical monitoring and 

treatment 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, Shanksville, PA, and at 

the Pentagon, and to eligible survivors 

of the New York City attacks. The 

proposed rule establishes the processes 

by which the WTC Program 

Administrator may add a new condition 

to the list of WTC-related health 

conditions through rulemaking, 

including a process for considering 

petitions by interested parties to add a 

new condition. 

DATES: HHS invites written comments 

from interested parties on this notice of 

proposed rulemaking and on the 

proposed information collection request 

sought under the Paperwork Reduction 

Act. Comments must be received by 

August 30, 2011. 

ADDRESSES: You may submit comments, 

identified by ‘‘RIN 0920–AA45,’’ by any 

of the following methods: 

• Internet: Access the Federal 

e-rulemaking portal at http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: NIOSH Docket Officer, 

nioshdocket@cdc.gov. Include ‘‘RIN 

0920–AA45’’ and ‘‘42 CFR 88’’ in the 

subject line of the message. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulation Identifier 

Number (RIN) for this rulemaking. All 

comments will be posted without 

change to http://www.regulations.gov 

and http://www.cdc.gov/niosh/docket/

NIOSHdocket0236.html, including any 

personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov or http://www.cdc.

gov/niosh/docket/NIOSH

docket0236.html. 

FOR FURTHER INFORMATION CONTACT: Roy 

M. Fleming, Sc.D., Senior Science 

Advisor, World Trade Center Health 

Program, Office of the Director, National 

Institute for Occupational Safety and 

Health, 1600 Clifton Road, NE., MS– 

E74, Atlanta, GA 30329; telephone 866– 

426–3673 (this is a toll-free number). 

Information request may also be 

submitted by e-mail to 

wtcpublicinput@cdc.gov. 

SUPPLEMENTARY INFORMATION: This 

preamble is organized as follows: 

I. Public Participation 

II. Background 

A. WTC Medical Monitoring and 

Treatment Program and Community 

Program History 

B. WTC Health Program Statutory 

Authority 

C. Addition of New Health Conditions for 

Coverage in the WTC Health Program 

III. Summary of the Proposed Rule 

IV. Regulatory Assessment Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

I. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

opinions, recommendations, and data. 

Comments received, including 

attachments and other supporting 

materials, are part of the public record 

and subject to public disclosure. Do not 

include any information in your 

comment or supporting materials that 

you consider confidential or 

inappropriate for public disclosure. 

Comments are invited on any topic 

related to this proposed rule. 

II. Background 

A. WTC Medical Monitoring and 

Treatment Program and the WTC 

Environmental Health Center 

Community Program History 

Since the tragic events of September 

11, 2001, HHS, CDC, and NIOSH have 

facilitated health evaluations for those 

firefighters and related personnel, law 

enforcement officers, and rescue, 

recovery and cleanup workers who 

responded to the WTC disaster sites. A 

health screening program for responders 

began in 2002 under contracts awarded 

to Mount Sinai School of Medicine 

(Mount Sinai) and the Fire Department, 

City of New York. Mount Sinai 

subcontracted with other specialty 

occupational health clinics in the New 

York metropolitan area to expand 

enrollment and provide a standardized 

and comprehensive health screening 

protocol. 

In 2003, Congress appropriated 

further funding to implement longer 

term medical monitoring for these 

responders. The occupational health 

specialty clinics involved in the 

screening program were each directly 

funded through cooperative agreements 

with NIOSH to work collaboratively and 

provide periodic standardized medical 

monitoring exams. Participants in the 

initial screening program were enrolled 

beginning in 2004. 

In 2006, Congress appropriated 

additional funds for diagnostic and 

treatment services to support medical 

care for health conditions associated 

with WTC-related work exposures. After 

receiving appropriations for treatment, 

the responder program was re-named 

the WTC Medical Monitoring and 

Treatment Program (MMTP) to reflect 

expanded services to eligible firefighters 

and related personnel, law enforcement 

officers, and rescue, recovery and 

cleanup workers. The established 

program providers were funded as 

Clinical Centers of Excellence (Clinical 

Centers) reflecting their 

multidisciplinary expertise and 

extensive program experience with the 

WTC responder population. The MMTP 

made monitoring exams and treatment 


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Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Proposed Rules 38939 

1Title XXXIII of the Public Health Service 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 

World Trade Center Health Program and are 

codified elsewhere. 

available to firefighters and related 

personnel, law enforcement officers, 

and rescue, recovery and cleanup 

workers living outside the New York 

metropolitan area and geographically 

distant from the established Clinical 

Centers through a network of providers. 

The health conditions covered under 

the MMTP were identified by the 

Clinical Centers based on assessments of 

the health needs of the firefighters and 

related personnel, law enforcement 

officers, and rescue, recovery and 

cleanup workers and with input from 

scientific and medical experts, and 

included certain upper and lower 

airway diseases, esophageal disorders 

from acid reflux, musculoskeletal 

injuries, and mental health problems 

(most notably post-traumatic stress 

disorder, anxiety, and depression). 

In 2008, Congress appropriated 

additional funds for the WTC 

Environmental Health Center (EHC) 

Community Program, which provided 

initial health evaluations, diagnostic 

and treatment services for residents, 

students, and others in the community 

who were affected by the September 11, 

2001, terrorist attacks in New York City. 

B. WTC Health Program Statutory 

Authority 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347), amended the Public 

Health Service Act (PHS Act) to add 

Title XXXIII 1 establishing the WTC 

Health Program within HHS. The WTC 

Health Program will assume the 

functions and goals of the MMTP and 

the EHC Community Program to provide 

medical monitoring and treatment 

benefits to eligible firefighters and 

related personnel, law enforcement 

officers, and rescue, recovery and 

cleanup workers (including those who 

are Federal employees) who responded 

to the September 11, 2001, terrorist 

attacks, and to eligible survivors of the 

New York City attacks. 

The WTC Health Program will expand 

the services of the MMTP to include 

eligible firefighters and related 

personnel, law enforcement officers, 

and rescue, recovery and cleanup 

workers who responded to the 

September 11, 2001, terrorist attacks at 

the Pentagon and Shanksville, PA. 

Section 3311(a)(2)(C)(ii) of Title XXXIII 

requires that the WTC Program 

Administrator develop eligibility 

criteria for Pentagon and Shanksville, 

PA emergency responders after 

consultation with the WTC Scientific/ 

Technical Advisory Committee. 

However, because no Pentagon or 

Shanksville, PA responders have 

participated in the existing MMTP, the 

WTC Program Administrator currently 

lacks information that may serve as a 

basis for such enrollment, including 

information on participation in the 

response at these two sites and on 

hazard exposure circumstances at these 

sites relevant to currently established 

WTC health conditions. The WTC 

Program Administrator will be 

collecting such information. 

Title XXXIII of the PHS Act 

authorizes the Secretary of HHS to 

designate a Department official to be the 

WTC Program Administrator (Title 

XXXIII, § 3306(14)). Certain specific 

activities of the WTC Program 

Administrator are reserved to the 

Secretary to delegate at her discretion; 

other WTC Program Administrator 

duties not explicitly reserved to the 

Secretary are assigned to the Director of 

NIOSH or his or her designee. This rule 

implements portions of the Act which 

were both given to the Director of 

NIOSH and others for which the HHS 

Secretary has designated the Director of 

NIOSH to be the WTC Program 

Administrator. Another HHS 

component, Centers for Medicare & 

Medicaid Services, has been delegated 

responsibilities for disbursing payments 

to providers under the WTC Health 

Program (see Delegation of Authority, 76 

FR 31337, May 31, 2011). All references 

to the WTC Program Administrator in 

this notice mean the NIOSH Director or 

his or her designee. 

Under section 3306 of Title XXXIII of 

the PHS Act, the WTC Program 

Administrator is responsible for a 

program to enroll qualified firefighters 

and related personnel, law enforcement 

officers, and rescue, recovery and 

cleanup workers who responded to the 

New York City, Pentagon, and 

Shanksville, PA disaster sites; screen 

and certify qualified survivors of the 

New York City attacks; and to establish 

a nationwide system of healthcare 

providers to provide monitoring and 

treatment to those individuals found 

eligible. The WTC Program 

Administrator is also required to 

promulgate regulations to determine 

medical necessity with respect to 

healthcare services and prescription 

pharmaceuticals; to certify WTC-related 

health conditions identified in the 

statute; and to establish processes for 

appealing adverse WTC Health Program 

determinations. Those statutory 

requirements are included in the 

interim final rule published elsewhere 

in this issue of the Federal Register. 

Title XXXIII of the PHS Act also 

authorizes the WTC Program 

Administrator to establish a process by 

which health conditions, including 

cancer, may be considered for addition 

to the list of WTC-related health 

conditions. Those provisions are 

included in this NPRM. 

C. Addition of New Health Conditions 

for Coverage in the WTC Health 

Program 

The list of WTC-related health 

conditions defined in sections 3312 and 

3322 of Title XXXIII of the PHS Act may 

be amended in the future to add other 

conditions 

for which exposure to airborne toxins, any 

other hazard, or any other adverse condition 

resulting from the September 11, 2001, 

terrorist attacks, based on an examination by 

a medical professional with experience in 

treating or diagnosing the health conditions 

included in the applicable list of WTCrelated health conditions, is substantially 

likely to be a significant factor in aggravating, 

contributing to, or causing the illness or 

condition (Title XXXIII, § 3312(a)(1)(A)(i)). 

Procedures for the addition of a new 

condition, which include rulemaking as 

required by Title XXXIII, are proposed 

in this notice. The addition of a new 

condition could be initiated either by 

petition from an interested party or at 

the discretion of the WTC Program 

Administrator, as specified in this 

proposed rule. 

III. Summary of Proposed Rule 

Section 88.1 Definitions 

This amendment to Part 88 would add 

the definition of ‘‘interested party’’ to 

the list of definitions. 

Section 88.17 Addition of Health 

Conditions to the List of WTC-Related 

Health Conditions 

Pursuant to requirements specified in 

Title XXXIII of the PHS Act, § 88.17 

would establish the process by which an 

interested party could petition the WTC 

Program Administrator to add a 

condition to the list of WTC-related 

health conditions identified in § 88.1. 

Under the provisions of (a)(1), the 

petition must include the name and 

contact information of the interested 

party; the name and description of the 

condition the party would like to see 

added to the list of WTC-related health 

conditions; and an explanation of the 

reasons for adding the condition, which 

must include the medical basis for the 

association between the September 11, 

2001, terrorist attacks and the condition 

to be added. The provisions of (a)(2) 

would incorporate specifications in 


jlentini on DSK4TPTVN1PROD with PROPOSALS3
38940 Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Proposed Rules 

Title XXXIII of the PHS Act regarding 

the addition of new conditions. Within 

60 days of receipt of the petition, the 

WTC Program Administrator will either: 

request a recommendation of the WTC 

Health Program Scientific/Technical 

Advisory Committee; open the proposed 

condition to public comment by 

publishing an NPRM in the Federal 

Register; publish the WTC Program 

Administrator’s determination not to 

publish an NPRM; or publish in the 

Federal Register a determination that 

not enough evidence exists to perform 

any of the above actions. If the WTC 

Program Administrator receives more 

than one petition to add a specific 

health condition, the WTC Program 

Administrator could consider them 

simultaneously under the process 

established by the provisions of this 

section. 

Subsection (b) would also incorporate 

the statutory requirement that the WTC 

Program Administrator may, 

periodically, publish an NPRM 

concerning the addition of a WTCrelated health condition. The 

Administrator would consider 

publishing an NPRM where the review 

of cancers required by Title XXXIII 

§ 3312(a)(5)(A) of the PHS Act indicates 

that a type of cancer should be added, 

or where WTC Health Program 

monitoring data reveals the prevalence 

of a condition not previously identified 

by the Program. Although the WTC 

Administrator cannot provide a specific 

scientific review protocol at this time, 

the protocol would take into account 

evaluating the exposure data associated 

with WTC and evaluating available 

published and unpublished 

epidemiologic, toxicologic, and medical 

evidence relevant to evaluating the 

possible association between the health 

condition under consideration and WTC 

exposures. How these various relevant 

sources of scientific and medical 

information will be evaluated, 

separately and in relation to each other 

would depend on the evidence available 

for a given health condition under 

consideration. HHS notes that scientists 

generally look for consistency in terms 

of disease-mechanism theories, 

toxicologic and epidemiologic findings, 

and medical observation. The addition 

of any health condition requires 

rulemaking and the public will have the 

opportunity to consider and comment 

on the review methods applied in any 

actual case. HHS solicits comment on 

this and other approaches to reviewing 

evidence. 

The WTC Program Administrator may 

extend the period described above upon 

finding a good cause. In the case of such 

an extension, the Administrator shall 

publish such an extension in the 

Federal Register. 

IV. Regulatory Assessment 

Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives of significant regulatory 

actions and, if regulation is necessary, to 

select regulatory approaches that 

maximize net benefits (including 

potential economic, environmental, 

public health and safety effects, 

distributive impacts, and equity). 

Executive Order 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. 

This proposed rule is considered a 

‘‘significant regulatory action’’ within 

the meaning of E.O. 12866. The rule 

establishes processes by which the WTC 

Program Administrator may consider 

the addition of health conditions to the 

current statutory list of WTC-related 

health conditions covered by this 

program. This strictly procedural rule 

does not itself propose the addition of 

any conditions and hence does not 

achieve any benefits nor impose any 

costs, other than the minor incidental 

administrative costs to HHS of 

considering possible additions. Under 

any circumstance, HHS would be 

required to conduct rulemaking to make 

an addition, as required by Title XXXIII 

of the PHS Act. Accordingly, any costs 

and benefits associated with adding a 

condition would be addressed in such 

future rulemaking. This rule does not 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, jobs, the environment, 

public health or safety, or State, local, 

or Tribal governments or communities; 

it does not create a serious 

inconsistency or otherwise interfere 

with an action taken or planned by 

another agency; it does not materially 

alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; nor does it raise 

novel legal or policy issues arising out 

of legal mandates, the President’s 

priorities, or the principles set forth in 

E.O. 12866. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601 et seq., requires each 

agency to consider the potential impact 

of its regulations on small entities 

including small businesses, small 

governmental units, and small not-forprofit organizations. HHS believes that 

this rule has ‘‘no significant economic 

impact upon a substantial number of 

small entities’’ within the meaning of 

the Regulatory Flexibility Act (5 U.S.C. 

601 et seq.). 

This regulation has no impact on 

small businesses or other small entities 

as specified under the RFA. The rule 

establishes procedures by which the 

WTC Health Program Administrator 

may consider the addition of health 

conditions to the current statutory list of 

WTC-related health conditions covered 

by this program. These procedures do 

not impose any requirements or direct 

costs on small entities. They do not 

involve small entities, except that a 

small entity could potentially be 

considered an ‘‘interested party’’ under 

these procedures, eligible to petition the 

WTC Program Administrator for the 

addition of a health condition. Such 

petitioning by a small entity would be 

voluntary, however, and hence any 

costs attendant to submitting a petition 

would be voluntarily incurred. 

The Secretary of HHS has certified to 

the Chief Counsel, Office of Advocacy of 

the Small Business Administration, that 

this rule does not have a significant 

impact on a substantial number of small 

entities. Accordingly, no regulatory 

impact analysis is required. 

C. Paperwork Reduction Act 

CDC has determined that this notice 

of proposed rulemaking contains 

information collection requirements that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act (PRA) of 

1995 (44 U.S.C. 3501–1420). A 

description of these provisions is given 

below with an estimate of the annual 

reporting burden. Included in the 

estimate of the annual reporting burden 

is the time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

each collection of information. In 

compliance with the requirement of 

§ 3506(c)(2)(A) of the PRA for 

opportunity for public comment on 

proposed data collection projects, CDC 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the data collection 

plans and instruments, call 404–639– 

5960 and send comments to Daniel 

Holcomb, CDC Reports Clearance 

Officer, 1600 Clifton Road, NE., MS– 

D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. 

Comments are invited on (a) whether 

the proposed collection of information 


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Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Proposed Rules 38941 

is necessary for the proper performance 

of the functions of the Agency, 

including whether the information shall 

have practical utility; (b) the accuracy of 

the Agency’s estimate of the burden of 

the proposed collection of information; 

(c) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents. Written comments 

should be received within 60 days of 

this notice. 

Proposed Project: Adding a Health 

Condition to the Statutory List of WTCRelated Health Conditions (42 CFR 

88)—New—National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description: 

Title I of the James Zadroga Health and 

Compensation Act of 2010 amended the 

Public Health Service Act (PHS Act) to 

establish the World Trade Center (WTC) 

Health Program. Sections 3311, 3312, 

and 3321 of Title XXXIII of the PHS Act 

require that the WTC Program 

Administrator develop regulations to 

implement portions of the WTC Health 

Program established within the 

Department of Health and Human 

Services (HHS). This proposed rule 

establishes the processes by which the 

WTC Program Administrator may add a 

new condition to the list of WTC-related 

health conditions through rulemaking, 

including a process for considering 

petitions by interested parties to add a 

new condition. The new provision is 

proposed at § 88.17 Addition of health 

conditions to the list of WTC-related 

health conditions. 

§ 88.17 Addition of Health Conditions 

to the List of WTC-Related Health 

Conditions 

This section describes the proposed 

process and data collection 

requirements that an interested party 

should follow to petition the WTC 

Program Administrator to add a 

condition to the list of WTC-related 

health conditions. HHS expects to 

receive no more than 100 petitions 

annually. We assume that interested 

parties will be enrolled WTC 

responders, certified-eligible survivors, 

or members of groups who advocate on 

behalf of responders or survivors. We 

estimate that an individual will spend 

an average of 40 hours gathering 

information to substantiate a request to 

add a health condition and assembling 

the petition. HHS requests input from 

the public on these estimates, which are 

reflected in the table below. 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Responder/Survivor/Advocate ...... Petition for the addition of health 

conditions.

100 1 40 4,000 

D. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (5 U.S.C. 801 et 

seq.), HHS will report the promulgation 

of this rule to Congress prior to its 

effective date. 

E. Unfunded Mandates Reform Act of 

1995 

Title II of the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1531 et 

seq.) directs agencies to assess the 

effects of Federal regulatory actions on 

State, local, and Tribal governments, 

and the private sector ‘‘other than to the 

extent that such regulations incorporate 

requirements specifically set forth in 

law.’’ For purposes of the Unfunded 

Mandates Reform Act, this proposed 

rule would not include any Federal 

mandate that may result in increased 

annual expenditures in excess of $100 

million by State, local or Tribal 

governments in the aggregate, or by the 

private sector. 

F. Executive Order 12988 (Civil Justice) 

This proposed rule has been drafted 

and reviewed in accordance with 

Executive Order 12988, ‘‘Civil Justice 

Reform,’’ and will not unduly burden 

the Federal court system. This rule has 

been reviewed carefully to eliminate 

drafting errors and ambiguities. 

G. Executive Order 13132 (Federalism) 

HHS has reviewed this proposed rule 

in accordance with Executive Order 

13132 regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does not ‘‘have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

In accordance with Executive Order 

13045, HHS has evaluated the 

environmental health and safety effects 

of this rule on children. HHS has 

determined that the rule would have no 

environmental health and safety effect 

on children. 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

In accordance with Executive Order 

13211, HHS has evaluated the effects of 

this proposed rule on energy supply, 

distribution or use, and has determined 

that the rule will not have a significant 

adverse effect. 

J. Plain Writing Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS has 

attempted to use plain language in 

promulgating the proposed rule 

consistent with the Federal Plain 

Writing Act guidelines. 

List of Subjects in 42 CFR Part 88 

Aerodigestive disorders, Appeal 

procedures, Health care, Mental health 

conditions, Musculoskeletal disorders, 

Respiratory and pulmonary diseases. 

Text of the Rule 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services proposes to amend 42 

CFR part 88 as follows: 

1. The authority citation for part 88 

continues to read as follows: 

Authority: 42 U.S.C. 300mm–300mm-61, 

Pub. L. 111–347, 124 Stat. 3623. 

2. Amend § 88.1 by adding the 

definition of ‘‘interested party’’ to read 

as follows: 


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38942 Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Proposed Rules 

§ 88.1 Definitions. 

* * * * * 

Interested party means a 

representative of any organization 

representing WTC responders, a 

nationally recognized medical 

association, a WTC Health Program 

Clinical Center of Excellence or Data 

Center, a State or political subdivision, 

or any other interested person. 

* * * * * 

2. Add § 88.17 to read as follows: 

§ 88.17 Addition of health conditions to 

the list of WTC-related health conditions 

(a) Any interested party may petition 

the WTC Program Administrator to add 

a condition to the list of WTC-related 

health conditions. 

(1) Each petition shall be in writing 

and sent to the WTC Program 

Administrator. The petition shall 

include: 

(i) Name and contact information of 

the interested party; 

(ii) Name and description of the 

condition to be added; and 

(iii) Reasons for adding the condition, 

including the medical basis for the 

association between the September 11, 

2001, terrorist attacks and the condition 

to be added. 

(2) Not later than 60 days after the 

receipt of a petition, the WTC Program 

Administrator shall: 

(i) Request a recommendation of the 

WTC Health Program Scientific/ 

Technical Advisory Committee; or 

(ii) Publish in the Federal Register a 

proposed rule to add such health 

condition; or 

(iii) Publish in the Federal Register 

the WTC Program Administrator’s 

determination not to publish a proposed 

rule and the basis for that 

determination; or 

(iv) Publish in the Federal Register a 

determination that insufficient evidence 

exists to take action under paragraph 

(a)(2)(i) through (iii) of this section. 

(b) The WTC Program Administrator 

may propose to add a condition to the 

list of WTC-related health conditions by 

publishing a proposed rule in the 

Federal Register and providing 

interested parties a period of 30 days to 

submit written comments. The WTC 

Program Administrator may extend the 

comment period for good cause. 

(1) If the WTC Program Administrator 

requests a recommendation from the 

WTC Health Program Scientific/ 

Technical Advisory Committee, the 

Advisory Committee shall submit its 

recommendation to the WTC Program 

Administrator no later than 60 days 

after the date of the transmission of the 

request or no later than a date specified 

by the Administrator (but not more than 

180 days after the request). 

(2) If the WTC Program Administrator 

decides to publish a proposed rule in 

the Federal Register, he or she shall do 

so no later than 60 days after the date 

of transmission of the Advisory 

Committee recommendation. 

Dated: May 6, 2011. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2011–16511 Filed 6–29–11; 8:45 am] 

BILLING CODE 4163–18–P 


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