24628 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 

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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

[FR Doc. 2012–9965 Filed 4–24–12; 8:45 am] 

BILLING CODE 6560–50–P 

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: Final rule. 

SUMMARY: Title I of the James Zadroga 

9/11 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 is administered by the 

Director of the National Institute for 

Occupational Safety and Health 

(NIOSH), within the Centers for Disease 

Control and Prevention (CDC), provides 

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. This final 

rule establishes the processes by which 

the WTC Program Administrator may 

add a new condition to the list of WTCrelated health conditions through 

rulemaking, including a process for 

considering petitions by interested 

parties to add a new condition. 

DATES: This final rule is effective May 

25, 2012. 

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 requests may also be 

submitted by email to 

wtcpublicinput@cdc.gov. 

SUPPLEMENTARY INFORMATION: This 

preamble is organized as follows: 

I. Public Participation 

II. Background 

A. WTC Health Program Statutory 

Authority 

B. Addition of New Health Conditions for 

Coverage in the WTC Health Program 

III. Summary of the Final Rule and Response 

to Comments 

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 

V. Final Rule 

I. Public Participation 

HHS received comments from six 

individuals and organizations on the 

notice of proposed rulemaking 

published in the Federal Register on 

July 1, 2011 (76 FR 38938). One 

anonymous commenter expressed anger 

about the WTC Health Program’s cost to 

American taxpayers; another individual 

asked that leukemia and other blood 

cancers be added to the list of WTCrelated health conditions; and a 

physician experienced with treating 

WTC-related health conditions 

requested that a mental disorder be 

added to the list of WTC-related health 

conditions. Those comments are outside 

the scope of this rulemaking and could 

not be considered. HHS received 

substantive comments from the New 

York State Laborers’ Health & Safety 

Trust Fund, the Communication 

Workers of America, and the WTC 

Health Program Survivor Steering 

Committee. Those comments are 

described and addressed below. 

II. Background 

A. WTC Health Program Statutory 

Authority 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

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

Health Service Act (PHS Act) to add 

Title XXXIII 1 establishing the WTC 

Health Program within HHS. HHS 

issued an interim final rule on July 1, 

2011 (76 FR 38914), which codified the 

Program in 42 CFR Part 88. Sections 

88.1 through 88.16 were included in 

that rulemaking; this final rule 

establishing § 88.17 was developed in a 

separate rulemaking. 

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 (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 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. The WTC Program 

Administrator has gathered information 

that may serve as a basis for such 

enrollment, and is working to develop 

eligibility criteria for these responder 

groups. 

All references to the WTC Program 

Administrator in this notice mean the 

NIOSH Director or his or her designee. 

Title XXXIII of the PHS Act 

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. This final rule establishes 

this process. 

B. 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 WTC-related health conditions, is 

substantially likely to be a significant 

factor in aggravating, contributing to, or 

causing the illness or condition (Title 

XXXIII, Sec. 3312(a)(1)(A)(i)). 

Procedures for the addition of a new 

condition are established in this final 

rule. The addition of a new condition 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 24629 

could be initiated either by petition 

from an interested party or at the 

discretion of the WTC Program 

Administrator, as specified in this final 

rule. 

III. Summary of Final Rule and 

Response to Comments 

Section 88.1 Definitions 

This amendment to Part 88 would add 

the definition of ‘‘interested party’’ to 

the list of definitions established by 

interim final rule on July 1, 2011 (76 FR 

38914). 

Comment: HHS received two 

comments requesting that the definition 

of ‘‘interested party’’ be expanded to 

reference survivor organizations. 

HHS response: The definition of 

‘‘interested party’’ was taken directly 

from Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010. 

Although the statutory definition of 

‘‘interested party’’ does not explicitly 

mention ‘‘survivor organizations,’’ HHS 

believes that the definition includes 

‘‘survivor organizations.’’ HHS does not 

agree that amending the rule text is 

necessary and is therefore not amending 

the definition. 

Section 88.17 Addition of Health 

Conditions to the List of WTC-Related 

Health Conditions 

In accordance with the requirements 

specified in Title XXXIII of the PHS Act, 

§ 88.17 establishes 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 § 88.17(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 the WTC 

Program Administrator to add 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. 

HHS has received some 

communications for which it is unclear 

whether the author intends to petition 

for the addition of a health condition or 

whether the author is expressing 

personal concerns. Since a petition 

results in Federal action, as specified 

under this rule, it is important that the 

intent to petition be unambiguous. 

Accordingly, HHS has amended the 

final rule text to clarify that the petition 

must state the petitioner’s intent to 

petition for the addition of a health 

condition. 

The provisions of § 88.17(a)(2) 

incorporate specifications in 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 (STAC); open the 

proposed condition to public comment 

by publishing a notice of proposed 

rulemaking (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. HHS has 

amended the final rule text to 

acknowledge that a petition may request 

the addition of more than one health 

condition. 

HHS has also inserted § 88.17(a)(4) 

into the final rule to clarify that the 

Administrator shall be required to 

reconsider a previously-considered (but 

not added) health condition for 

inclusion on the list of WTC-related 

health conditions in response to a 

petition only when the petition includes 

a new medical basis for the association 

between the terrorist attacks and the 

condition. A new medical basis could 

include a health study, whether original 

or updated, not previously considered 

by the WTC Program Administrator. A 

new clinical case report on a particular 

health condition which compiles data 

from one or more patients may not 

necessarily be considered a new 

medical basis if the Administrator has 

previously considered one or more cases 

of the health condition. The 

Administrator retains the discretion, 

however, to reconsider a health 

condition for any reason on his own 

initiative, with or without the receipt of 

a petition. 

Comment: One commenter requested 

that all submitted petitions be shared 

with the STAC regardless of whether the 

WTC Program Administrator seeks a 

formal recommendation from the 

Committee. 

HHS response: HHS appreciates this 

suggestion and agrees that, in the 

interest of keeping the STAC informed 

of relevant public interest, petitions 

received by the WTC Program 

Administrator will be shared with the 

Committee and with the public via the 

Program’s Web site. HHS does not 

believe that amending the rule text is 

warranted. 

Comment: A commenter also asked 

that a mechanism be developed to allow 

at least two members of the STAC to 

request to consider a petition and make 

a recommendation in the event that the 

WTC Program Administrator has 

determined not to publish an NPRM or 

where the Administrator determines 

that insufficient evidence exists to take 

action on a petition. 

HHS response: According to the 

requirements of Title XXXIII of the PHS 

Act, the Committee’s role is to review 

evidence and make recommendations to 

the WTC Program Administrator at the 

request of the Administrator, not to 

provide unsolicited reviews. Any work 

conducted by the STAC must be 

consistent with the purposes for which 

the Committee may be utilized as 

identified by the statute and the 

Committee charter. Therefore, this 

comment is not adopted. 

Subsection (b) also incorporates the 

statutory requirement that the WTC 

Program Administrator may publish an 

NPRM concerning the addition of a 

WTC-related health condition to the list. 

The Administrator would consider 

publishing an NPRM where the review 

of cancers required by Sec. 3312(a)(5)(A) 

of Title XXXIII of the PHS Act indicates 

that a type of cancer should be added, 

or where the review of WTC Health 

Program monitoring data reveals the 

prevalence of a condition not previously 

identified by the statute or Program. The 

protocol for such a review will take into 

account an evaluation of the exposure 

data associated with the terrorist 

attacks, and an evaluation of available 

epidemiologic, toxicologic, and medical 

evidence relevant to evaluating the 

possible association between the health 

condition under consideration and 

exposures associated with the 

September 11, 2001, terrorist attacks. 

How these various relevant sources of 

scientific and medical information will 

be evaluated, separately and in relation 

to each other, will depend on the 

evidence available for a given health 

condition under consideration. HHS 

notes that scientists generally look for 

consistency in terms of diseasemechanism 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. 

The WTC Program Administrator may 

extend the comment period described 

above based upon a finding of good 

cause. In the case of such an extension, 

the Administrator shall publish notice 

in the Federal Register. 

Comment: HHS received several 

comments concerning deadlines not 

specified in the regulatory text. One 

commenter suggested that HHS did not 

include every deadline related to the 

addition of a WTC-related health 


srobinson on DSK4SPTVN1PROD with RULES
24630 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 

condition provided by the statute. Two 

comments asked that we specify a time 

frame for the publication of an NPRM or 

a Federal Register notice indicating that 

the WTC Program Administrator has 

determined not to publish an NPRM; 

one asked that we specify the 

publication of an NPRM 30 days 

following a STAC recommendation. 

Comments also requested that we 

specify a time frame for publication of 

a final rule; one asked that we require 

publication within 60 days after the 

close of an NPRM comment period. 

HHS response: Each deadline 

specified by the PHS Act with regard to 

this matter has been incorporated into 

the regulatory text. We have specified a 

time frame for the publication of an 

NPRM following a STAC 

recommendation in Sec. 88.17(b)(2) 

according to the time frame specified in 

the statute. We agree with commenters 

who pointed out that we neglected to 

specify a time frame for publication of 

a Federal Register notice indicating a 

decision not to publish an NPRM 

following receipt of a STAC 

recommendation, and have amended 

the rule text accordingly. However, 

Congress did not specify a time frame 

for publication of a final rule. HHS is 

concerned that establishing such 

requirements by regulation could 

negatively impact the thorough review 

of scientific evidence supporting or 

opposing the inclusion of a specific 

health condition. Because of the need to 

ensure that a thorough review has been 

conducted in all cases, HHS is not 

making changes to the rule based on 

these comments. Every effort will be 

made to promptly review public 

comments and STAC recommendations, 

and that publication of a final rule will 

occur in as efficient and timely a 

manner as is possible. 

Comment: One commenter requested 

that HHS develop procedures for the 

WTC Program Administrator to notify 

an individual when a new condition is 

added, if the individual was previously 

denied coverage for that condition. 

HHS response: Information about 

newly-added WTC-related health 

conditions will be provided on the WTC 

Health Program Web site and shared 

with all Program physicians. Program 

physicians would be best placed to 

advise individuals on whether applying 

for certification of a newly-designated 

WTC-related health condition is 

appropriate. The WTC Health Program 

will consider this request further to 

identify other ways in which Program 

participants may be notified of a new 

WTC-related health condition. 

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 final 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 it does not 

provide for 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 

quantifiable 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. 

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 

HHS has determined that this final 

rule contains data collection and record 

keeping requirements that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1955 (44 U.S.C. 3501– 

3420). 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. These data collection and 

record keeping requirements have been 

approved under OMB control number 

0920–0929, exp. April 30, 2015. 

Project: Adding a Health Condition to 

the Statutory List of WTC–Related 

Health Conditions (42 CFR 88.17)— 

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 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 24631 

Services (HHS). This final 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 process will be 

codified at 42 CFR 88.17. 

Section 88.17, entitled ‘‘Addition of 

Health Conditions to the List of WTC– 

Related Health Conditions,’’ describes 

the 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, screening-eligible survivors, 

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. The total burden on the 

public is estimated to be 4,000 hours. 

Type of respondent Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Responder/Survivor/Advocate ........................ Petition for the addition of health conditions 100 1 40 

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 final rule 

does 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. 

For 2011, the inflation adjusted 

threshold is $136 million. 

F. Executive Order 12988 (Civil Justice) 

This final 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 final 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 final 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 final rule consistent 

with the Federal Plain Writing Act 

guidelines. 

V. Final Rule 

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 amends 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’’ in 

alphabetical order to read as follows: 

§ 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. 

* * * * * 

■ 3. 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 state an intent 

to petition and be 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(s) to be added; and 

(iii) Reasons for adding the 

condition(s), including the medical 

basis for the association between the 

September 11, 2001, terrorist attacks 

and the condition(s) 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 


srobinson on DSK4SPTVN1PROD with RULES
24632 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 

(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. 

(3) The WTC Program Administrator 

may consider more than one petition 

simultaneously when the petitions 

propose the addition of the same health 

condition. Scientific/Technical 

Advisory Committee recommendations 

and Federal Register notices initiated 

by the WTC Program Administrator 

pursuant to paragraph (a)(2) of this 

section may respond to more than one 

petition. 

(4) The WTC Program Administrator 

shall be required to consider a new 

petition for a health condition 

previously reviewed by the WTC 

Program Administrator and determined 

not to qualify for addition to the list of 

WTC-related health conditions only if 

the new petition presents a new medical 

basis (i.e., not previously reviewed) for 

the association between the September 

11, 2001, terrorist attacks and the 

condition to be added. 

(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). If the WTC 

Program Administrator decides to 

publish a proposed rule or a 

determination not 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. 

(2) [Reserved] 

Dated: January 26, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–9425 Filed 4–24–12; 8:45 am] 

BILLING CODE P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 14 

[CG Docket No. 10–213 and 10–145, WT 

Docket No. 96–198; FCC 11–151] 

Implementing the Provisions of the 

Communications Act of 1934, as 

Enacted by the Twenty-First Century 

Communications and Video 

Accessibility Act of 2010 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection associated with 

the Commission’s document 

Implementing the Provisions of the 

Communications Act of 1934, as 

Enacted by the Twenty-First Century 

Communications and Video 

Accessibility Act of 2010, (Report and 

Order). This notice is consistent with 

the Report and Order, which stated that 

the Commission would publish a 

document in the Federal Register 

announcing the effective date of those 

rules. 

DATES: The amendments to 47 CFR 14.5, 

14.20(d), 14.31, 14.32, and 14.34 

through 14.52, published at 76 FR 

82354, December 30, 2011, are effective 

April 25, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Rosaline Crawford, Disability Rights 

Office, Consumer and Governmental 

Affairs Bureau, at (202) 418–2075, or 

email Rosaline.Crawford@fcc.gov. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on April 16, 

2012, OMB approved, for a period of 

three years, the information collection 

requirements contained in the 

Commission’s Report and Order, FCC 

11–151, published at 76 FR 82354, 

December 30, 2011. The OMB Control 

Number is 3060–1167. The Commission 

publishes this notice as an 

announcement of the effective date of 

the rules. If you have any comments on 

the burden estimates listed below, or 

how the Commission can improve the 

collections and reduce any burdens 

caused thereby, please contact Cathy 

Williams, Federal Communications 

Commission, Room 1–C823, 445 12th 

Street SW., Washington, DC 20554. 

Please include the OMB Control 

Number, 3060–1167, in your 

correspondence. The Commission will 

also accept your comments via the 

Internet if you send them to 

PRA@fcc.gov <mailto:PRA@fcc.gov>. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to 

fcc504@fcc.gov <mailto:fcc504@fcc.gov> 

or call the Consumer and Governmental 

Affairs Bureau at (202) 418–0530 

(voice), (202) 418–0432 (TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received OMB approval on April 16, 

2012, for the information collection 

requirements contained in the 

Commission’s rules at 47 CFR 14.5, 

14.20(d), 14.31, 14.32, and 14.34 

through 14.52. 

Under 5 CFR 1320, an agency may not 

conduct or sponsor a collection of 

information unless it displays a current, 

valid OMB Control Number. 

No person shall be subject to any 

penalty for failing to comply with a 

collection of information subject to the 

Paperwork Reduction Act that does not 

display a current, valid OMB Control 

Number. The OMB Control Number is 

3060–1167. 

The foregoing notice is required by 

the Paperwork Reduction Act of 1995, 

Pub. L. 104–13, October 1, 1995, and 

44 U.S.C. 3507. 

The total annual reporting burdens 

and costs for the respondents are as 

follows: 

OMB Control Number: 3060–1167. 

OMB Approval Date: April 16, 2012. 

OMB Expiration Date: April 30, 2015. 

Title: Accessible Telecommunications 

and Advanced Communications 

Services and Equipment. 

Form Number: N/A. 

Type of Review: New collection. 

Respondents: Individuals or 

households; businesses or other forprofit entities; not-for-profit institutions. 

Number of Respondents and 

Responses: 9,454 respondents; 119,660 

responses. 

Estimated Time per Response: .50 to 

40 hours. 

Frequency of Response: Annual, one 

time, and on occasion reporting 

requirements; recordkeeping 

requirement; third-party disclosure 

requirement. 

Obligation to Respond: Mandatory. 

Statutory authority for this information 


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