Revised Medical Criteria for Evaluating Cancer (Malignant Neoplastic Diseases), 28821-28832 [2015-11923]

Agencies

• Social Security Administration

[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Rules and Regulations]
[Pages 28821-28832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11923]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Docket No. SSA-2011-0098]
RIN 0960-AH43


Revised Medical Criteria for Evaluating Cancer (Malignant 
Neoplastic Diseases)

AGENCY: Social Security Administration.

ACTION: Final rule.

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SUMMARY: We are revising the criteria in parts A and B of the Listing 
of Impairments (listings) that we use to evaluate claims involving 
cancer (malignant neoplastic diseases) under titles II and XVI of the 
Social Security Act (Act). These revisions reflect our adjudicative 
experience, advances in medical knowledge, recommendations from medical 
experts we consulted, and public comments we received in response to a 
Notice of Proposed Rulemaking (NPRM).

DATES: This rule is effective July 20, 2015.

[[Page 28822]]


FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of Medical 
Policy, Social Security Administration, 6401 Security Boulevard, 
Baltimore, Maryland 21235-6401, (410) 965-1020. For information on 
eligibility or filing for benefits, call our national toll-free number, 
1-800-772-1213, or TTY 1-800-325-0778, or visit our Internet site, 
Social Security Online, at https://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

Background

    We are revising and making final the regulations for evaluating 
cancer (malignant neoplastic diseases) that we proposed in an NPRM 
published in the Federal Register on December 17, 2013, at 78 FR 76508. 
Even though this rule will not go into effect until 60 days after 
publication of this document, for clarity we refer to it in this 
preamble as the ``final'' rule. We refer to the rule in effect prior to 
that time as the ``prior'' rule.
    In the preamble to the NPRM, we discussed our proposed changes and 
our reasons for making them. Since we are mostly adopting those 
revisions as we proposed them, we are not repeating that information 
here. Interested readers may refer to the preamble in the NPRM, 
available at https://www.regulations.gov.
    We are making some changes in this final rule based on the public 
comments we received on the NPRM. We explain these changes in the 
``Summary of Public Comments'' below.

Why are we revising the cancer listings?

    We developed this final rule as part of our ongoing review of the 
cancer body system. When we last revised the listings for this body 
system in a final rule published on October 6, 2009, we indicated that 
we would monitor and update the listings as needed.\1\
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    \1\ See 74 FR 51229.
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How long will this final rule stay in effect?

    We are extending the effective date of the cancer body system in 
parts A and B of the listings until 5 years after the effective date of 
this final rule. The rule will remain in effect only until that date 
unless we extend the expiration date. We will continue to monitor the 
rule and may revise it, as needed, before the end of the 5-year period.

Summary of Public Comments

    In the NPRM, we gave the public a 60-day comment period that ended 
on February 18, 2014. We received 15 comments. The commenters included 
national cancer advocacy groups, State agencies, a national group 
representing disability examiners in State agencies that make 
disability determinations for us, medical professionals, and individual 
members of the public.
    We carefully considered all of the significant comments relevant to 
this rulemaking. We have condensed and summarized the comments below. 
We believe we have presented the commenters' concerns and suggestions 
accurately and completely and responded to all significant issues that 
were within the scope of this rule. We provide our reasons for adopting 
or not adopting the recommendations in our responses below.

General Comments

    Comment: Many commenters supported our proposal to change the name 
of this body system from ``Malignant Neoplastic Diseases'' to 
``Cancer'' to make the name more recognizable to the lay public. 
However, some commenters believed this change was not necessary or 
appropriate. These commenters believed the lay public is sufficiently 
aware of the meaning of the term ``malignant neoplastic diseases'' and 
that we should continue using it as the body system's name. One 
commenter thought ``malignant neoplastic diseases'' is a more 
encompassing name for the body system than ``cancer.'' The commenter 
contended the term ``cancer'' has traditionally meant only carcinoma, 
and does not include sarcoma, leukemia, or malignancies in other cell 
types.
    Response: We disagree with the commenters' view that the lay public 
is sufficiently aware of the term ``malignant neoplastic diseases,'' 
and have adopted our proposal to change the name of this body system to 
``Cancer.'' We believe the lay public understands that the term 
``cancer'' means not only carcinoma but also the wide array of 
malignancies. The National Cancer Institute (NCI), National Cancer 
Society (NCS), and other recognized experts use the term ``cancer'' 
when referring to carcinoma, sarcoma, leukemia, lymphoma, and 
malignancies of the central nervous system in their publications.\2\
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    \2\ For example, see ``NCI Home'' at https://www.cancer.gov, and 
``American Cancer Society Home'' at https://www.cancer.org/index.
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    Comment: A commenter, who supported the proposed name change, 
recommended that we use the term ``anticancer therapy'' instead of 
``antineoplastic therapy'' in this final rule.
    Response: We agree with the commenter and have modified the 
listings accordingly.
    Comment: One commenter suggested we have only one listing for 
evaluating small-cell carcinomas rather than adopt our proposal to 
provide a criterion for small-cell carcinoma under several, specific 
listings.\3\
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    \3\ We retained prior listing 13.14B for evaluating small-cell 
carcinoma in the lungs and added a criterion for small-cell 
carcinoma under the following specific listings: 13.02D for soft 
tissue cancers of the head and neck; 13.10D for cancer of the 
breast; 13.15C for cancer of the pleura and mediastinum; 13.16C for 
cancer of the esophagus or stomach; 13.17C for cancer of the small 
intestine; 13.18D for cancer of the large intestine; 13.22E for 
cancer of the urinary bladder; 13.23F for cancers of the female 
genital tract; and 13.24C for cancer of the prostate gland. We 
include a listing for small-cell carcinoma of the small intestine, 
even though it is a very rare cancer, to maintain internal 
consistency among the regulations, and because of the cancer's 
unfavorable prognosis.
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    Response: We did not adopt the comment. Some small-cell carcinomas 
might be included under the single listing the commenter proposed, but 
may have favorable prognoses and not be of listing-level severity. 
These small-cell carcinomas have a favorable prognosis because 
physicians can detect them in their early stages when it is still 
possible to remove the cancer. The final listings cover small-cell 
carcinomas that occur in certain organs and tissues where physicians 
are unlikely to detect them in their early stages, and treatment is 
mainly palliative.
    Comment: One commenter suggested that we include the stage of the 
cancer in the final listings for evaluating central nervous system and 
cervical cancers, and lymphomas.
    Response: We did not adopt the comment for two reasons. First, the 
cancers mentioned by the commenter may have different staging systems 
that are inconsistent with each other. Second, staging systems could 
change, potentially resulting in an inability to find people with 
listing-level impairments disabled at the listing step of the 
sequential evaluation process.
    Comment: A commenter proposed we provide more guidance in part B 
for evaluating conditions in children, resulting from cancer or its 
treatment, that do not meet the listings. The commenter said such 
conditions might include organ dysfunction resulting from small-cell 
carcinomas, or secondary lymphedema resulting from breast cancer 
treatment. The commenter believed the additional guidance would make 
the final listings more comprehensive.
    Response: We did not adopt the comment because we believe final 
sections 113.00F and 113.00G already

[[Page 28823]]

provide the type of guidance the commenter recommended. In these 
sections, we explain that if a child has a medically determinable 
impairment that does not meet the listings, we will determine whether 
the impairment medically equals the listings. This determination would 
include impairments caused by the cancer or treatment side effects. If 
the impairment does not medically equal a listing, section 113.00F 
further explains that we will also determine whether the impairment 
functionally equals the listings. Again, this determination would 
include impairments caused by the cancer or treatment side effects.
    Comment: One commenter recommended we provide more guidance for 
evaluating treatment failure in bone marrow and stem cell 
transplantation, and proposed specific language for making this change.
    Response: We believe the change, and the specific language the 
commenter proposed, is not necessary because listings for bone marrow 
and stem cell transplantation have a criterion for evaluating any 
residual impairments following treatment. These residual impairments 
would include the evaluation of those associated with treatment 
failure.

Section 13.00E--When do we need longitudinal evidence?

    Comment: One commenter asked us to specify which sources can 
provide the evidence required in final section 13.00E3c to document 
that the treating source has started multimodal therapy under final 
listings 13.02E, 13.11D, and 13.14C. The commenter indicated that we 
should accept this evidence only from an acceptable medical source such 
as a medical or osteopathic doctor.
    Response: We did not adopt the comment because it may limit our 
ability to obtain evidence to determine if multimodal therapy has 
started and, thus, establish listing-level severity. While an 
acceptable medical source may provide this evidence, our existing 
policy allows us to accept evidence from other medical sources to 
establish the impairment's severity.\4\ For example, this evidence may 
come from sources we do not consider acceptable medical sources, such 
as oncology nurse practitioners who administer chemotherapy and 
radiation therapists who deliver radiation treatments.
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    \4\ See 20 CFR 404.1513(d) and 416.913(d).
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Sections 13.00I and 113.00I--What do we mean by the following terms?

    Comment: One commenter expressed concern over proposed sections 
13.00I6 and 113.00I5, in which we clarified that we consider a cancer 
to be ``progressive'' if it is still growing after the person has 
completed at least half of his or her planned initial anticancer 
therapy. The commenter believed this criterion might delay adjudication 
if the adjudicator must contact the treating source to ask how much of 
planned treatment the person has completed.
    Response: We did not adopt this comment. We disagree with the 
commenter because we do not expect adjudicators to obtain more 
information than we required under the prior regulations. The proposed 
and final sections express our intent to decide as quickly as possible 
that a person is disabled.
    Comment: The same commenter thought that the definition of the term 
``progressive'' could result in a finding that the claimant has a 
condition medically equivalent to cancer listings that do not require 
the malignancy to be progressive.
    Response: We do not share the commenter's concern because, as we 
explain in sections 13.00C and 113.00C, we will only apply the criteria 
in a specific listing to a cancer originating from that specific site.
    Comment: One commenter recommended that we revise the definition of 
``persistent'' cancer in final section 13.00I5. The commenter also 
provided language for the suggested revision.
    Response: We did not adopt the comment for two reasons. First, the 
language the commenter proposed could be misinterpreted to require that 
all of a person's anticancer therapy must fail to achieve a complete 
remission, including any second- or third-line therapies after initial 
anticancer therapy.\5\ This interpretation would be contrary to our 
intent in listings that require only the planned initial anticancer 
therapy to fail. Second, the language the commenter proposed would not 
explain the meaning of the phrase ``failed to achieve a complete 
remission.'' By defining this phrase, the final section clarifies that 
the cancer is ``persistent'' if any of it remains after treatment is 
completed, even if the cancer responded to the initial therapy and 
became smaller.
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    \5\ We may consider follow-up surgery to be a part of initial 
anticancer treatment if the intent of the follow-up surgery is to 
obtain clear margins and the complete eradication of any residual 
cancer left behind.
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    Comment: One commenter recommended that the definition of the term 
``unresectable'' in final section 13.00I8 address the presence of 
micrometastases. The commenter contended that ``unresectable'' should 
not include situations in which the surgeon removed the tumor and then 
used adjuvant therapy to eliminate any micrometastases.
    Response: We did not adopt the comment. We believe the commenter's 
proposed change is unnecessary. Final section 13.00I8 defines 
``adjuvant therapy'' as anticancer therapy given after surgery ``to 
eliminate any remaining cancer cells or lessen the chance of 
recurrence.'' These ``remaining cancer cells'' include micrometastases.

Sections 13.00K and 113.00K--How do we evaluate specific cancers?

    Comment: A commenter recommended that we add examples of common 
indolent lymphomas in final section 13.00K1a. The commenter also 
recommended that we add examples of common solid tumors in final 
section 113.00K3.
    Response: We did not adopt the comment. These recommendations 
appear to be administrative concerns better handled through training 
and operating instructions for our adjudicators.
    Comment: A commenter recommended that we create a listing for 
primary peritoneal carcinoma. The commenter argued that having a 
listing would be better than the guidance in section 13.00K7, in which 
we explained that we can evaluate this cancer in women under final 
13.23E for ovarian cancer, and evaluate it in men under 13.15A for 
malignant mesothelioma.
    Response: We did not adopt the commenter's recommendation that we 
create a listing for primary peritoneal carcinoma. Primary peritoneal 
carcinoma is very rare, and we do not usually provide listings for rare 
cancers. Instead, we believe the better practice is to clarify in the 
introductory text which listings to use to evaluate certain rare 
cancers, as we did in final section 13.00K7 for primary peritoneal 
carcinoma.
    Comment: A few commenters expressed concern about the clarification 
in proposed section 13.00K8 that excludes ``biochemical recurrence'' 
for evaluating recurrent cancer of the prostate gland in listing 
13.24A. In this section, we defined ``biochemical recurrence'' as an 
increase in the serum prostate-specific antigen (PSA) level following 
the completion of anticancer therapy. Section 13.24A requires 
corroborating evidence to document recurrence, such as radiological 
studies or findings on physical exam. Commenters believed this 
requirement might delay a finding

[[Page 28824]]

of disability and unfairly penalize people with prostate cancer. They 
noted that doctors frequently use PSA values to determine recurrence 
and may initiate anticancer treatment for recurrent cancer upon this 
evidence alone.
    Response: We agree that in some cases, an isolated PSA reading may 
support a diagnosis of recurrent prostate cancer, especially if this 
diagnosis is from an acceptable medical source and is consistent with 
the prevailing state of medical knowledge and clinical practice. 
However, we did not adopt the comments because we believe it is 
reasonable to require corroborating evidence to confirm the diagnosis. 
A rising PSA level alone does not necessarily mean prostate cancer has 
returned. Additional factors, such as the cancer's TNM \6\ 
characteristics, PSA kinetics, timing of the biochemical recurrence, 
treatment modality, and Gleason score, should be 
considered.7 8 The American Joint Committee on Cancer notes 
that the natural progression from biochemical recurrence to clinical 
disease recurrence is highly variable and may depend on these 
additional factors.\9\ In light of this variability and the other 
factors that should be considered, we continue to believe that we 
should exclude ``biochemical recurrence'' in listing 13.24A.
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    \6\ The acronym ``TNM'' relates to the Tumor size, lymph Node 
involvement, and presence of Metastases.
    \7\ PSA kinetics involves assessing the PSA level over time, 
such as measuring of its rate of change (velocity) and how long it 
takes it to double.
    \8\ The National Cancer Institute defines ``Gleason score'' as a 
system of grading prostate cancer tissue based on how it looks under 
the microscope (available at: https://www.cancer.gov/dictionary?CdrID=45696).
    \9\ See Carolyn C. Compton et al. eds., Cancer Staging Atlas: A 
Companion to the Seventh Editions of the AJCC Cancer Staging Manual 
and Handbook, New York: Springer, 2012, page 535-545.
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    Comment: One commenter recommended that we delete the parenthetical 
reference to ``benign melanocytic tumor'' in final sections 13.00K9 and 
113.00K6. The commenter claimed that citing a benign disease in the 
cancer listings may be confusing for adjudicators.
    Response: We did not adopt the comment because we believe the 
reference to benign melanocytic tumor can direct adjudicators to the 
appropriate body systems for evaluating this condition, Skin Disorders 
(8.00 and 108.00). This reference is similar to how final sections 
13.00K6c and 113.00K4c direct adjudicators to the appropriate body 
systems for evaluating benign brain tumors.

Listing 13.02--Soft Tissue Cancers of the Head and Neck (Except 
Salivary Glands--13.08--and Thyroid Gland--13.09)

    Comment: A commenter recommended revisions to 13.02E to condense 
the final listing significantly.
    Response: We did not adopt the comment because the proposed change 
might be misinterpreted to include any metastases in the head or neck 
from cancers originating elsewhere under listing 13.02E. Our intent in 
this listing is to evaluate cancers that receive multimodal therapy and 
originate in the head and neck only.

Listing 113.05--Lymphoma (Excluding All Types of Lymphoblastic 
Lymphomas--113.06)

    Comment: A commenter recommended that we include cerebrospinal 
fluid (CSF) findings as evidence for determining listing-level lymphoma 
under final listings 113.05A1 and 113.05B1.
    Response: We did not adopt the comment. It is not a standard 
clinical practice in lymphoma to conduct cerebrospinal fluid 
examination for analysis; therefore, we do not believe it is 
appropriate to require this evidence to establish severity. However, we 
will inform adjudicators, through training and operating instructions, 
that they can accept CSF findings if this evidence is available.

Listing 13.10--Breast (Except Sarcoma--13.04)

    Comment: One commenter asked how long adjudicators should defer 
adjudication of cases for evaluating breast cancer with secondary 
lymphedema resulting from anticancer therapy and treated by surgery to 
salvage or restore the functioning of an upper extremity under proposed 
listing 13.10E.
    Response: We disagree with the commenter's premise that 
adjudicators need to defer adjudication of these cases. Adjudicators 
can adjudicate a case at the listing step if the surgery is performed. 
The need for this surgery to salvage or restore functioning of an upper 
extremity demonstrates listing-level severity of the secondary 
lymphedema without the need to make a determination about the 
effectiveness of the surgery.
    Comment: A commenter recommended we add a listing that prescribes a 
period of disability of at least 18 months for people receiving 
multimodal therapy for breast cancer. The commenter noted that 
multimodal therapy could last 6 or more months and produce very serious 
adverse effects. The commenter also noted that it is common for us to 
find these people disabled after the listing step in the sequential 
evaluation process by taking into consideration the adverse effects of 
treatment and that the length of treatment nearly satisfies the 12-
month duration requirement. The commenter believed it would be better 
for us to make the determination of disability at the listing step.
    Similarly, a commenter recommended we add a listing that prescribes 
a period of disability of at least 18 months for people receiving 
multimodal therapy that includes surgery for low anal cancers and 
rectal cancers. The commenter noted that neoadjuvant chemotherapy or 
radiation followed by surgery to eliminate these anal or rectal cancers 
frequently takes at least 12 months to complete. The treatment may 
result in prolonged debilitation although the impairment may not meet 
or medically equal the listings.
    Response: We believe the commenter's proposed listing for breast 
cancer would cover many cases of early cancer. Most people with early 
breast cancer complete multimodal therapy within 6 months and recover 
from any adverse effects relatively soon. In these cases, the 
impairment would not preclude the ability to work for the required 12 
months.
    However, we agree with the commenter that in some cases multimodal 
therapy may take substantially longer than 6 months to complete. For 
example, very serious adverse effects may interrupt and prolong 
therapy, resulting in an active impairment lasting almost 12 months. It 
is a long-standing principle that we may make a finding of disability 
at the listing step if there is the expectation that an impairment that 
has been active for almost 12 months will preclude a person from 
engaging in any gainful activity for the required 12 months. We base 
this finding on the nature of the impairment; prescribed treatment; 
therapeutic history, including adverse effects of treatment; and other 
relevant considerations. Therefore, we partially adopted the comment by 
providing language in final section 13.00G3 to clarify that we can 
apply this principle to multimodal anticancer therapy for breast cancer 
and other cancers. We also added the clarifying language in final 
section 113.00G3 for children.
    We did not make changes to listing 13.18 for evaluating anal and 
rectal cancers. This listing and the commenter's recommendation for a 
new listing covering multimodal therapy with surgery for anal and 
rectal cancers

[[Page 28825]]

are outside the scope of this rulemaking. However, we believe the 
changes made in final section 13.00G3 partially address this 
commenter's concerns.

Listing 13.13--Nervous System

    Comment: One commenter recommended that we clarify in the 
introductory text whether adjudicators should use listing 13.13 to 
evaluate pituitary gland cancer in adults.
    Response: We adopted the commenter's recommendation by providing 
language in final section 13.00K6a and final section 113.00K4a in the 
introductory text clarifying that we evaluate cancerous pituitary gland 
tumors, for example, pituitary carcinoma,\10\ under final listing 
13.13A1 and final listing 113.13A, respectively.
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    \10\ Pituitary gland carcinoma is highly malignant. Treatment is 
mainly palliative. People who have pituitary gland carcinoma have a 
mean survival time of only about 2 years.
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    Comment: The same commenter expressed concern about the statement, 
in proposed sections 13.00K6b and 113.00K4b, that we consider brain 
tumors malignant only if they are classified as grade II or higher 
under the World Health Organization (WHO), ``Classification of Tumours 
of the Central Nervous System, 2007.'' The commenter asked how an 
adjudicator should evaluate central nervous system tumors graded under 
different classification systems.
    Response: We believe we have addressed the commenter's concerns in 
existing operating instructions that help adjudicators determine the 
WHO grade of specific brain cancers if a different grading system is 
used or if the medical evidence does not identify a particular grading 
system.\11\ These instructions also help adjudicators determine which 
grade to use when there are inconsistencies in the medical record, such 
as some medical evidence describing the tumor as grade II while other 
medical evidence describes it as grade III or grade IV.
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    \11\ Program Operations Manual System, available at: https://policy.ssa.gov/poms.nsf/lnx/0424585001.
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Listing 13.23--Cancers of the Female Genital Tract--Carcinoma or 
Sarcoma

    Comment: A commenter recommended that we add criteria in final 
listing 13.23B3 to take into account a cancer's histologic diagnosis 
and the age of the claimant at onset.
    Response: We did not adopt this comment. We do not believe it is 
necessary to include such considerations in the listing because the 
prognosis is already poor for cervical cancer that meets the specific 
criteria of the listing. Considering the histological diagnosis would 
only confirm this prognosis, and the prognosis would remain poor 
regardless of a person's age.
    Comment: A national advocacy group for women with ovarian cancer 
recommended that we reinstate a listing we deleted in 2009. The listing 
covered ovarian cancer with ruptured ovarian capsule, tumor on the 
serosal surface of the ovary, ascites with malignant cells, or positive 
peritoneal washings. The commenter believed we find most women with 
this extent of disease disabled at later steps of the sequential 
evaluation process after the listing step or on appeal. The commenter 
also believed the adverse effects of cancer treatment might be 
disabling in themselves, especially for women whose jobs require 
significant exertion or do not allow time off for recovery from 
treatment.
    Response: We agree we could find a woman with the findings in the 
prior listing disabled after the listing step of the sequential 
evaluation process. We realize that adverse effects of ovarian cancer 
treatment may preclude a woman from working. However, we did not adopt 
the commenter's recommendation because many women with ovarian cancer 
that meets the specific criteria in the deleted listing would not have 
an impairment that precludes any gainful activity, which is the 
standard of severity in the listings.\12\
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    \12\ See sections 404.1525 and 416.925.
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Other Changes

    We made a number of editorial changes and technical corrections in 
the final rule to increase the clarity and consistency of the listings. 
For example, we redesignated proposed listing 13.05A3 for evaluating 
mantle cell lymphoma in adults as final listing 13.05D to make it a 
stand-alone listing consistent with stand-alone final listing 113.05D 
for evaluating mantle cell lymphoma in children. We also changed the 
parenthetical examples in prior sections 13.00H1 and 113.00H1 from ``at 
least 18 months from the date of diagnosis'' and ``at least 12 months 
from the date of diagnosis,'' respectively, to ``until at least 12 
months from the date of transplantation'' to make these adult and child 
sections consistent.
    Additionally, we redesignated proposed listings 13.29A3 and 
113.29A3 for evaluating mucosal melanoma as stand-alone listings 13.29C 
and 113.29C. We made this change because we determined, through our 
ongoing review of the scientific and medical literature, that mucosal 
melanoma carries a very poor prognosis and is of listing-level severity 
regardless of whether it is an initial disease or a recurrent disease. 
We also added examples of distant sites frequently affected by 
metastases from cutaneous and ocular melanomas in 13.29B3 and 113.29B3.

What is our authority to make regulations and set procedures for 
determining whether a person is disabled under the statutory 
definition?

    Under the Act, we have full power and authority to make rules and 
regulations and to establish necessary and appropriate procedures to 
carry out such provisions.\13\
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    \13\ Sections 205(a), 702(a)(5), and 1631(d)(1).
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Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

    We have consulted with the Office of Management and Budget (OMB) 
and determined that this final rule meets the criteria for a 
significant regulatory action under Executive Order 12866, as 
supplemented by Executive Order 13563, and was reviewed by OMB.

Regulatory Flexibility Act

    We certify that this final rule has no significant economic impact 
on a substantial number of small entities because it affects only 
individuals. Therefore, a regulatory flexibility analysis was not 
required under the Regulatory Flexibility Act, as amended.

Paperwork Reduction Act

    This final rule does not create any new or affect any existing 
collections and, therefore, does not require OMB approval under the 
Paperwork Reduction Act.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security--Disability Insurance; 96.002, Social Security--Retirement 
Insurance; 96.004, Social Security--Survivors Insurance; and 96.006, 
Supplemental Security Income).

List of Subjects in 20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, 
Old-age, Survivors, and Disability Insurance, Reporting and 
recordkeeping requirements, Social Security.

    Dated: May 11, 2015.
Carolyn W. Colvin,
Acting Commissioner of Social Security.

    For the reasons set out in the preamble, we are amending 20 CFR 
part 404 subpart P as set forth below:

[[Page 28826]]

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950-)

Subpart P--Determining Disability and Blindness

0
1. The authority citation for subpart P of part 404 continues to read 
as follows:

    Authority:  Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a), 
(i), and (j), 222(c), 223, 225, and 702(a)(5) of the Social Security 
Act (42 U.S.C. 402, 405(a)-(b), and (d)-(h), 416(i), 421(a), (i), 
and (j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-
193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 
(42 U.S.C. 902 note).


0
2. Amend appendix 1 to subpart P of part 404 as follows:
0
a. Revise item 14 of the introductory text before part A.
0
b. Amend part A by revising the body system name for section 13.00 in 
the table of contents.
0
c. Revise section 13.00 of part A.
0
d. Amend listing 13.02 of part A by revising the heading, revising 
listing 13.02B, removing listing 13.02C, redesignating listing 13.02D 
as new 13.02C, adding new listing 13.02D and revising listing 13.02E.
0
e. Amend listing 13.03 of part A by revising listing 13.03B.
0
f. Amend listing 13.04 of part A by revising listing 13.04B.
0
g. Amend listing 13.05 of part A by revising listings 13.05A1, 13.05A2 
and 13.05B, and adding listing 13.05D.
0
h. Amend listing 13.06 of part A by revising the first sentence of 
listing 13.06B1 and revising listing 13.06B2b.
0
i. Amend listing 13.07 of part A by revising listing 13.07A.
0
j. Amend listing 13.10 of part A by revising listings 13.10A and 
13.10C, adding the word ``OR'' after listing 13.10C, adding listing 
13.10D, adding the word ``OR'' after listing 13.10D, and adding listing 
13.10E.
0
k. Amend listing 13.11 of part A by revising listings 13.11B and 
13.11D.
0
l. Amend listing 13.12 of part A by revising listing 13.12C.
0
m. Revise listing 13.13 of part A.
0
n. Amend listing 13.14C of part A by revising the first sentence.
0
o. Amend listing 13.15 of part A by revising listing 13.15B2 and adding 
the word ``OR'' after listing 13.15B2, and adding listing 13.15C.
0
p. Amend listing 13.16 of part A by adding the word ``OR'' after 
listing 13.16B, and adding listing 13.16C.
0
q. Amend listing 13.17 of part A by adding the word ``OR'' after 
listing 13.17B, and adding listing 13.17C.
0
r. Amend listing 13.18 of part A by adding the word ``OR'' after 
listing 13.18C, and adding listing 13.18D.
0
s. Revise listing 13.19 of part A.
0
t. Amend listing 13.20 of part A by revising listing 13.20B.
0
u. Amend listing 13.22 of part A by adding the word ``OR'' after 
listing 13.22D, and adding listing 13.22E.
0
v. Amend listing 13.23 of part A by revising the heading, revising 
listings 13.23A3, 13.23B, 13.23C3, 13.23D2 and 13.23E, adding the word 
``OR'' after listing 13.23E, and adding listing 13.23F.
0
w. Amend listing 13.24 of part A by revising listing 13.24A, adding the 
word ``OR'' after listing 13.24B, and adding listing 13.24C.
0
x. Revise listing 13.25 of part A.
0
y. Amend listing 13.28 of part A by revising the heading.
0
z. Add listing 13.29 after listing 13.28 of part A.
0
aa. Amend part B by revising the body system name for section 113.00 in 
the table of contents.
0
bb. Revise section 113.00 of part B.
0
cc. Revise listing 113.03 of part B.
0
dd. Amend listing 113.05 of part B by revising the heading and listings 
113.05A and 113.05B, adding the word ``OR'' after listing 113.05C, and 
adding listing 113.05D.
0
ee. Amend listing 113.06 of part B by revising listings 113.06A and 
113.06B1.
0
ff. Amend listing 113.12 of part B by revising listing 113.12B.
0
gg. Revise listing 113.13 of part B.
0
hh. Add listing 113.29 after listing 113.21 of part B.
    The revised and added text is set forth as follows:

APPENDIX 1 TO SUBPART P OF PART 404--LISTING OF IMPAIRMENTS

* * * * *
    14. Cancer (Malignant Neoplastic Diseases) (13.00 and 113.00): 
July 20, 2020.
* * * * *

Part A

* * * * *

13.00 Cancer (Malignant Neoplastic Diseases)

* * * * *

13.00 CANCER (MALIGNANT NEOPLASTIC DISEASES)

    A. What impairments do these listings cover? We use these 
listings to evaluate all cancers (malignant neoplastic diseases), 
except certain cancers associated with human immunodeficiency virus 
(HIV) infection. If you have HIV infection, we use the criteria in 
14.08E to evaluate carcinoma of the cervix, Kaposi sarcoma, 
lymphoma, and squamous cell carcinoma of the anal canal and anal 
margin.
    B. What do we consider when we evaluate cancer under these 
listings? We will consider factors including:
    1. Origin of the cancer.
    2. Extent of involvement.
    3. Duration, frequency, and response to anticancer therapy.
    4. Effects of any post-therapeutic residuals.
    C. How do we apply these listings? We apply the criteria in a 
specific listing to a cancer originating from that specific site.
    D. What evidence do we need?
    1. We need medical evidence that specifies the type, extent, and 
site of the primary, recurrent, or metastatic lesion. When the 
primary site cannot be identified, we will use evidence documenting 
the site(s) of metastasis to evaluate the impairment under 13.27.
    2. For operative procedures, including a biopsy or a needle 
aspiration, we generally need a copy of both the:
    a. Operative note, and
    b. Pathology report.
    3. When we cannot get these documents, we will accept the 
summary of hospitalization(s) or other medical reports. This 
evidence should include details of the findings at surgery and, 
whenever appropriate, the pathological findings.
    4. In some situations, we may also need evidence about 
recurrence, persistence, or progression of the cancer, the response 
to therapy, and any significant residuals. (See 13.00G.)
    E. When do we need longitudinal evidence?
    1. Cancer with distant metastases. We generally do not need 
longitudinal evidence for cancer that has metastasized beyond the 
regional lymph nodes because this cancer usually meets the 
requirements of a listing. Exceptions are for cancer with distant 
metastases that we expect to respond to anticancer therapy. For 
these exceptions, we usually need a longitudinal record of 3 months 
after therapy starts to determine whether the therapy achieved its 
intended effect, and whether this effect is likely to persist.
    2. Other cancers. When there are no distant metastases, many of 
the listings require that we consider your response to initial 
anticancer therapy; that is, the initial planned treatment regimen. 
This therapy may consist of a single modality or a combination of 
modalities; that is, multimodal therapy. (See 13.00I4.)
    3. Types of treatment.
    a. Whenever the initial planned therapy is a single modality, 
enough time must pass to allow a determination about whether the 
therapy will achieve its intended effect. If the treatment fails, 
the failure often happens within 6 months after treatment starts, 
and there will often be a change in the treatment regimen.
    b. Whenever the initial planned therapy is multimodal, we 
usually cannot make a determination about the effectiveness of the 
therapy until we can determine the effects of all the planned 
modalities. In some cases, we may need to defer adjudication until 
we can assess the effectiveness of therapy. However, we do not need 
to defer adjudication to determine whether the therapy will achieve 
its intended effect if we can make a fully favorable determination 
or decision based on the length and effects of therapy, or the 
residuals of the cancer or therapy (see 13.00G).
    c. We need evidence under 13.02E, 13.11D, and 13.14C to 
establish that your treating

[[Page 28827]]

source initiated multimodal anticancer therapy. We do not need to 
make a determination about the length or effectiveness of your 
therapy. Multimodal therapy has been initiated, and satisfies the 
requirements in 13.02E, 13.11D, and 13.14C, when your treating 
source starts the first modality. We may defer adjudication if your 
treating source plans multimodal therapy and has not yet initiated 
it.
    F. How do we evaluate impairments that do not meet one of the 
cancer listings?
    1. These listings are only examples of cancer that we consider 
severe enough to prevent you from doing any gainful activity. If 
your severe impairment(s) does not meet the criteria of any of these 
listings, we must also consider whether you have an impairment(s) 
that meets the criteria of a listing in another body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. (See Sec. Sec.  404.1526 
and 416.926 of this chapter.) If your impairment(s) does not meet or 
medically equal a listing, you may or may not have the residual 
functional capacity to engage in substantial gainful activity. In 
that situation, we proceed to the fourth, and, if necessary, the 
fifth steps of the sequential evaluation process in Sec. Sec.  
404.1520 and 416.920 of this chapter. We use the rules in Sec. Sec.  
404.1594 and 416.994 of this chapter, as appropriate, when we decide 
whether you continue to be disabled.
    G. How do we consider the effects of anticancer therapy?
    1. How we consider the effects of anticancer therapy under the 
listings. In many cases, cancers meet listing criteria only if the 
therapy is not effective and the cancer persists, progresses, or 
recurs. However, as explained in the following paragraphs, we will 
not delay adjudication if we can make a fully favorable 
determination or decision based on the evidence in the case record.
    2. Effects can vary widely.
    a. We consider each case on an individual basis because the 
therapy and its toxicity may vary widely. We will request a specific 
description of the therapy, including these items:
    i. Drugs given.
    ii. Dosage.
    iii. Frequency of drug administration.
    iv. Plans for continued drug administration.
    v. Extent of surgery.
    vi. Schedule and fields of radiation therapy.
    b. We will also request a description of the complications or 
adverse effects of therapy, such as the following:
    i. Continuing gastrointestinal symptoms.
    ii. Persistent weakness.
    iii. Neurological complications.
    iv. Cardiovascular complications.
    v. Reactive mental disorders.
    3. Effects of therapy may change. The severity of the adverse 
effects of anticancer therapy may change during treatment; 
therefore, enough time must pass to allow us to evaluate the 
therapy's effect. The residual effects of treatment are temporary in 
most instances; however, on occasion, the effects may be disabling 
for a consecutive period of at least 12 months. In some situations, 
very serious adverse effects may interrupt and prolong multimodal 
anticancer therapy for a continuous period of almost 12 months. In 
these situations, we may determine there is an expectation that your 
impairment will preclude you from engaging in any gainful activity 
for at least 12 months.
    4. When the initial anticancer therapy is effective. We evaluate 
any post-therapeutic residual impairment(s) not included in these 
listings under the criteria for the affected body system. We must 
consider any complications of therapy. When the residual 
impairment(s) does not meet or medically equal a listing, we must 
consider its effect on your ability to do substantial gainful 
activity.
    H. How long do we consider your impairment to be disabling?
    1. In some listings, we specify that we will consider your 
impairment to be disabling until a particular point in time (for 
example, until at least 12 months from the date of transplantation). 
We may consider your impairment to be disabling beyond this point 
when the medical and other evidence justifies it.
    2. When a listing does not contain such a specification, we will 
consider an impairment(s) that meets or medically equals a listing 
in this body system to be disabling until at least 3 years after 
onset of complete remission. When the impairment(s) has been in 
complete remission for at least 3 years, that is, the original tumor 
or a recurrence (or relapse) and any metastases have not been 
evident for at least 3 years, the impairment(s) will no longer meet 
or medically equal the criteria of a listing in this body system.
    3. Following the appropriate period, we will consider any 
residuals, including residuals of the cancer or therapy (see 
13.00G), in determining whether you are disabled. If you have a 
recurrence or relapse of your cancer, your impairment may meet or 
medically equal one of the listings in this body system again.
    I. What do we mean by the following terms?
    1. Anticancer therapy means surgery, radiation, chemotherapy, 
hormones, immunotherapy, or bone marrow or stem cell 
transplantation. When we refer to surgery as an anticancer 
treatment, we mean surgical excision for treatment, not for 
diagnostic purposes.
    2. Inoperable means surgery is thought to be of no therapeutic 
value or the surgery cannot be performed; for example, when you 
cannot tolerate anesthesia or surgery because of another 
impairment(s), or you have a cancer that is too large or that has 
invaded crucial structures. This term does not include situations in 
which your cancer could have been surgically removed but another 
method of treatment was chosen; for example, an attempt at organ 
preservation. Your physician may determine whether the cancer is 
inoperable before or after you receive neoadjuvant therapy. 
Neoadjuvant therapy is anticancer therapy, such as chemotherapy or 
radiation, given before surgery in order to reduce the size of the 
cancer.
    3. Metastases means the spread of cancer cells by blood, lymph, 
or other body fluid. This term does not include the spread of cancer 
cells by direct extension of the cancer to other tissues or organs.
    4. Multimodal therapy means anticancer therapy that is a 
combination of at least two types of treatment given in close 
proximity as a unified whole and usually planned before any 
treatment has begun. There are three types of treatment modalities: 
surgery, radiation, and systemic drug therapy (chemotherapy, hormone 
therapy, and immunotherapy or biological modifier therapy). Examples 
of multimodal therapy include:
    a. Surgery followed by chemotherapy or radiation.
    b. Chemotherapy followed by surgery.
    c. Chemotherapy and concurrent radiation.
    5. Persistent means the planned initial anticancer therapy 
failed to achieve a complete remission of your cancer; that is, your 
cancer is evident, even if smaller, after the therapy has ended.
    6. Progressive means the cancer becomes more extensive after 
treatment; that is, there is evidence that your cancer is growing 
after you have completed at least half of your planned initial 
anticancer therapy.
    7. Recurrent or relapse means the cancer that was in complete 
remission or entirely removed by surgery has returned.
    8. Unresectable means surgery or surgeries did not completely 
remove the cancer. This term includes situations in which your 
cancer is incompletely resected or the surgical margins are 
positive. It does not include situations in which there is a finding 
of a positive margin(s) if additional surgery obtains a margin(s) 
that is clear. It also does not include situations in which the 
cancer is completely resected but you are receiving adjuvant 
therapy. Adjuvant therapy is anticancer therapy, such as 
chemotherapy or radiation, given after surgery in order to eliminate 
any remaining cancer cells or lessen the chance of recurrence.
    J. Can we establish the existence of a disabling impairment 
prior to the date of the evidence that shows the cancer satisfies 
the criteria of a listing? Yes. We will consider factors such as:
    1. The type of cancer and its location.
    2. The extent of involvement when the cancer was first 
demonstrated.
    3. Your symptoms.
    K. How do we evaluate specific cancers?
    1. Lymphoma.
    a. Many indolent (non-aggressive) lymphomas are controlled by 
well-tolerated treatment modalities, although the lymphomas may 
produce intermittent symptoms and signs. We may defer adjudicating 
these cases for an appropriate period after therapy is initiated to 
determine whether the therapy will achieve its intended effect, 
which is usually to stabilize the disease process. (See 13.00E3.) 
Once your disease stabilizes, we will assess severity based on the 
extent of involvement of other organ systems and residuals from 
therapy.
    b. A change in therapy for indolent lymphomas is usually an 
indicator that the therapy is not achieving its intended effect. 
However, your impairment will not meet the requirements of 13.05A2 
if your therapy is changed solely because you or your

[[Page 28828]]

physician chooses to change it and not because of a failure to 
achieve stability.
    c. We consider Hodgkin lymphoma that recurs more than 12 months 
after completing initial anticancer therapy to be a new disease 
rather than a recurrence.
    2. Leukemia.
    a. Acute leukemia. The initial diagnosis of acute leukemia, 
including the accelerated or blast phase of chronic myelogenous 
(granulocytic) leukemia, is based on definitive bone marrow 
examination. Additional diagnostic information is based on 
chromosomal analysis, cytochemical and surface marker studies on the 
abnormal cells, or other methods consistent with the prevailing 
state of medical knowledge and clinical practice. Recurrent disease 
must be documented by peripheral blood, bone marrow, or 
cerebrospinal fluid examination, or by testicular biopsy. The 
initial and follow-up pathology reports should be included.
    b. Chronic myelogenous leukemia (CML). We need a diagnosis of 
CML based on documented granulocytosis, including immature forms 
such as differentiated or undifferentiated myelocytes and 
myeloblasts, and a chromosomal analysis that demonstrates the 
Philadelphia chromosome. In the absence of a chromosomal analysis, 
or if the Philadelphia chromosome is not present, the diagnosis may 
be made by other methods consistent with the prevailing state of 
medical knowledge and clinical practice. The requirement for CML in 
the accelerated or blast phase is met in 13.06B if laboratory 
findings show the proportion of blast (immature) cells in the 
peripheral blood or bone marrow is 10 percent or greater.
    c. Chronic lymphocytic leukemia.
    i. We require the diagnosis of chronic lymphocytic leukemia 
(CLL) to be documented by evidence of a chronic lymphocytosis of at 
least 10,000 cells/mm\3\ for 3 months or longer, or other acceptable 
diagnostic techniques consistent with the prevailing state of 
medical knowledge and clinical practice.
    ii. We evaluate the complications and residual impairment(s) 
from CLL under the appropriate listings, such as 13.05A2 or the 
hematological listings (7.00).
    d. Elevated white cell count. In cases of chronic leukemia 
(either myelogenous or lymphocytic), an elevated white cell count, 
in itself, is not a factor in determining the severity of the 
impairment.
    3. Macroglobulinemia or heavy chain disease. We require the 
diagnosis of these diseases to be confirmed by protein 
electrophoresis or immunoelectrophoresis. We evaluate the resulting 
impairment(s) under the appropriate listings, such as 13.05A2 or the 
hematological listings (7.00).
    4. Primary breast cancer.
    a. We evaluate bilateral primary breast cancer (synchronous or 
metachronous) under 13.10A, which covers local primary disease, and 
not as a primary disease that has metastasized.
    b. We evaluate secondary lymphedema that results from anticancer 
therapy for breast cancer under 13.10E if the lymphedema is treated 
by surgery to salvage or restore the functioning of an upper 
extremity. Secondary lymphedema is edema that results from 
obstruction or destruction of normal lymphatic channels. We may not 
restrict our determination of the onset of disability to the date of 
the surgery; we may establish an earlier onset date of disability if 
the evidence in your case record supports such a finding.
    5. Carcinoma-in-situ. Carcinoma-in-situ, or preinvasive 
carcinoma, usually responds to treatment. When we use the term 
``carcinoma'' in these listings, it does not include carcinoma-in-
situ.
    6. Primary central nervous system (CNS) cancers. We use the 
criteria in 13.13 to evaluate cancers that originate within the CNS 
(that is, brain and spinal cord cancers).
    a. The CNS cancers listed in 13.13A1 are highly malignant and 
respond poorly to treatment, and therefore we do not require 
additional criteria to evaluate them. We do not list pituitary gland 
cancer (for example, pituitary gland carcinoma) in 13.13A1, although 
this CNS cancer is highly malignant and responds poorly to 
treatment. We evaluate pituitary gland cancer under 13.13A1 and do 
not require additional criteria to evaluate it.
    b. We consider a CNS tumor to be malignant if it is classified 
as Grade II, Grade III, or Grade IV under the World Health 
Organization (WHO) classification of tumors of the CNS (WHO 
Classification of Tumours of the Central Nervous System, 2007).
    c. We evaluate benign (for example, WHO Grade I) CNS tumors 
under 11.05. We evaluate metastasized CNS cancers from non-CNS sites 
under the primary cancers (see 13.00C). We evaluate any 
complications of CNS cancers, such as resultant neurological or 
psychological impairments, under the criteria for the affected body 
system.
    7. Primary peritoneal carcinoma. We use the criteria in 13.23E 
to evaluate primary peritoneal carcinoma in women because this 
cancer is often indistinguishable from ovarian cancer and is 
generally treated the same way as ovarian cancer. We use the 
criteria in 13.15A to evaluate primary peritoneal carcinoma in men 
because many of these cases are similar to malignant mesothelioma.
    8. Prostate cancer. We exclude ``biochemical recurrence'' in 
13.24A, which is defined as an increase in the serum prostate-
specific antigen (PSA) level following the completion of the 
hormonal intervention therapy. We need corroborating evidence to 
document recurrence, such as radiological studies or findings on 
physical examination.
    9. Melanoma. We evaluate malignant melanoma that affects the 
skin (cutaneous melanoma), eye (ocular melanoma), or mucosal 
membranes (mucosal melanoma) under 13.29. We evaluate melanoma that 
is not malignant that affects the skin (benign melanocytic tumor) 
under the listings in 8.00 or other affected body systems.
    L. How do we evaluate cancer treated by bone marrow or stem cell 
transplantation, including transplantation using stem cells from 
umbilical cord blood? Bone marrow or stem cell transplantation is 
performed for a variety of cancers. We require the transplantation 
to occur before we evaluate it under these listings. We do not need 
to restrict our determination of the onset of disability to the date 
of the transplantation (13.05, 13.06, or 13.07) or the date of first 
treatment under the treatment plan that includes transplantation 
(13.28). We may be able to establish an earlier onset date of 
disability due to your transplantation if the evidence in your case 
record supports such a finding.
    1. Acute leukemia (including T-cell lymphoblastic lymphoma) or 
accelerated or blast phase of CML. If you undergo bone marrow or 
stem cell transplantation for any of these disorders, we will 
consider you to be disabled until at least 24 months from the date 
of diagnosis or relapse, or at least 12 months from the date of 
transplantation, whichever is later.
    2. Lymphoma, multiple myeloma, or chronic phase of CML. If you 
undergo bone marrow or stem cell transplantation for any of these 
disorders, we will consider you to be disabled until at least 12 
months from the date of transplantation.
    3. Other cancers. We will evaluate any other cancer treated with 
bone marrow or stem cell transplantation under 13.28, regardless of 
whether there is another listing that addresses that impairment. The 
length of time we will consider you to be disabled depends on 
whether you undergo allogeneic or autologous transplantation.
    a. Allogeneic bone marrow or stem cell transplantation. If you 
undergo allogeneic transplantation (transplantation from an 
unrelated donor or a related donor other than an identical twin), we 
will consider you to be disabled until at least 12 months from the 
date of transplantation.
    b. Autologous bone marrow or stem cell transplantation. If you 
undergo autologous transplantation (transplantation of your own 
cells or cells from your identical twin (syngeneic 
transplantation)), we will consider you to be disabled until at 
least 12 months from the date of the first treatment under the 
treatment plan that includes transplantation. The first treatment 
usually refers to the initial therapy given to prepare you for 
transplantation.
    4. Evaluating disability after the appropriate time period has 
elapsed. We consider any residual impairment(s), such as 
complications arising from:
    a. Graft-versus-host (GVH) disease.
    b. Immunosuppressant therapy, such as frequent infections.
    c. Significant deterioration of other organ systems.
* * * * *
    13.02 Soft tissue cancers of the head and neck (except salivary 
glands--13.08--and thyroid gland--13.09).
* * * * *
    B. Persistent or recurrent disease following initial anticancer 
therapy, except persistence or recurrence in the true vocal cord.
* * * * *
    D. Small-cell (oat cell) carcinoma.
OR
    E. Soft tissue cancers originating in the head and neck treated 
with multimodal anticancer therapy (see 13.00E3c). Consider under a 
disability until at least 18 months from the date of diagnosis. 
Thereafter,

[[Page 28829]]

evaluate any residual impairment(s) under the criteria for the 
affected body system.
    13.03 Skin (except malignant melanoma--13.29).
* * * * *
    B. Carcinoma invading deep extradermal structures (for example, 
skeletal muscle, cartilage, or bone).
    13.04 Soft tissue sarcoma.
* * * * *
    B. Persistent or recurrent following initial anticancer therapy.
    13.05 Lymphoma (including mycosis fungoides, but excluding T-
cell lymphoblastic lymphoma--13.06). (See 13.00K1 and 13.00K2c.)
    A. Non-Hodgkin lymphoma, as described in 1 or 2:
    1. Aggressive lymphoma (including diffuse large B-cell lymphoma) 
persistent or recurrent following initial anticancer therapy.
    2. Indolent lymphoma (including mycosis fungoides and follicular 
small cleaved cell) requiring initiation of more than one (single 
mode or multimodal) anticancer treatment regimen within a period of 
12 consecutive months. Consider under a disability from at least the 
date of initiation of the treatment regimen that failed within 12 
months.
OR
    B. Hodgkin lymphoma with failure to achieve clinically complete 
remission, or recurrent lymphoma within 12 months of completing 
initial anticancer therapy.
* * * * *
OR
    D. Mantle cell lymphoma.
    13.06 Leukemia. (See 13.00K2.)
* * * * *
    B. * * *
    1. Accelerated or blast phase (see 13.00K2b). * * *
* * * * *
    2. Chronic phase, as described in a or b:
* * * * *
    b. Progressive disease following initial anticancer therapy.
    13.07 Multiple myeloma (confirmed by appropriate serum or urine 
protein electrophoresis and bone marrow findings).
    A. Failure to respond or progressive disease following initial 
anticancer therapy.
* * * * *
    13.10 Breast (except sarcoma--13.04). (See 13.00K4.)
    A. Locally advanced cancer (inflammatory carcinoma, cancer of 
any size with direct extension to the chest wall or skin, or cancer 
of any size with metastases to the ipsilateral internal mammary 
nodes).
* * * * *
    C. Recurrent carcinoma, except local recurrence that remits with 
anticancer therapy.
OR
    D. Small-cell (oat cell) carcinoma.
OR
    E. With secondary lymphedema that is caused by anticancer 
therapy and treated by surgery to salvage or restore the functioning 
of an upper extremity. (See 13.00K4b.) Consider under a disability 
until at least 12 months from the date of the surgery that treated 
the secondary lymphedema. Thereafter, evaluate any residual 
impairment(s) under the criteria for the affected body system.
    13.11 Skeletal system--sarcoma.
* * * * *
    B. Recurrent cancer (except local recurrence) after initial 
anticancer therapy.
* * * * *
    D. All other cancers originating in bone with multimodal 
anticancer therapy (see 13.00E3c). Consider under a disability for 
12 months from the date of diagnosis. Thereafter, evaluate any 
residual impairment(s) under the criteria for the affected body 
system.
    13.12 Maxilla, orbit, or temporal fossa.
* * * * *
    C. Cancer with extension to the orbit, meninges, sinuses, or 
base of the skull.
    13.13 Nervous system. (See 13.00K6.)
    A. Primary central nervous system (CNS; that is, brain and 
spinal cord) cancers, as described in 1, 2, or 3:
    1. Glioblastoma multiforme, ependymoblastoma, and diffuse 
intrinsic brain stem gliomas (see 13.00K6a).
    2. Any Grade III or Grade IV CNS cancer (see 13.00K6b), 
including astrocytomas, sarcomas, and medulloblastoma and other 
primitive neuroectodermal tumors (PNETs).
    3. Any primary CNS cancer, as described in a or b:
    a. Metastatic.
    b. Progressive or recurrent following initial anticancer 
therapy.
OR
    B. Primary peripheral nerve or spinal root cancers, as described 
in 1 or 2:
    1. Metastatic.
    2. Progressive or recurrent following initial anticancer 
therapy.
    13.14 Lungs.
* * * * *
    C. Carcinoma of the superior sulcus (including Pancoast tumors) 
with multimodal anticancer therapy (see 13.00E3c). * * *
* * * * *
    13.15 Pleura or mediastinum.
* * * * *
    B. * * *
    2. Persistent or recurrent following initial anticancer therapy.
OR
    C. Small-cell (oat cell) carcinoma.
    13.16 Esophagus or stomach.
* * * * *
    B. * * *
OR
    C. Small-cell (oat cell) carcinoma.
    13.17 Small intestine--carcinoma, sarcoma, or carcinoid.
* * * * *
    B. * * *
OR
    C. Small-cell (oat cell) carcinoma.
    13.18 Large intestine (from ileocecal valve to and including 
anal canal).
* * * * *
    C. * * *
OR
    D. Small-cell (oat cell) carcinoma.
    13.19 Liver or gallbladder--cancer of the liver, gallbladder, or 
bile ducts.
    13.20 Pancreas.
* * * * *
    B. Islet cell carcinoma that is physiologically active and is 
either inoperable or unresectable.
* * * * *
    13.22 Urinary bladder--carcinoma.
* * * * *
    D. * * *
OR
    E. Small-cell (oat cell) carcinoma.
    13.23 Cancers of the female genital tract--carcinoma or sarcoma 
(including primary peritoneal carcinoma).
    A. * * *
    3. Persistent or recurrent following initial anticancer therapy.
    B. Uterine cervix, as described in 1, 2, or 3:
    1. Extending to the pelvic wall, lower portion of the vagina, or 
adjacent or distant organs.
    2. Persistent or recurrent following initial anticancer therapy.
    3. With metastases to distant (for example, para-aortic or 
supraclavicular) lymph nodes.
    C. * * *
    3. Persistent or recurrent following initial anticancer therapy.
    D. * * *
    2. Persistent or recurrent following initial anticancer therapy.
    E. Ovaries, as described in 1 or 2:
    1. All cancers except germ-cell cancers, with at least one of 
the following:
    a. Extension beyond the pelvis; for example, implants on, or 
direct extension to, peritoneal, omental, or bowel surfaces.
    b. Metastases to or beyond the regional lymph nodes.
    c. Recurrent following initial anticancer therapy.
    2. Germ-cell cancers--progressive or recurrent following initial 
anticancer therapy.
OR
    F. Small-cell (oat cell) carcinoma.
    13.24 Prostate gland--carcinoma.
    A. Progressive or recurrent (not including biochemical 
recurrence) despite initial hormonal intervention. (See 13.00K8.)
OR
    B. * * *
OR
    C. Small-cell (oat cell) carcinoma.
    13.25 Testicles--cancer with metastatic disease progressive or 
recurrent following initial chemotherapy.
* * * * *
    13.28 Cancer treated by bone marrow or stem cell 
transplantation. (See 13.00L.)
* * * * *
    13.29 Malignant melanoma (including skin, ocular, or mucosal 
melanomas), as described in either A, B, or C:
    A. Recurrent (except an additional primary melanoma at a 
different site, which is not considered to be recurrent disease) 
following either 1 or 2:
    1. Wide excision (skin melanoma).
    2. Enucleation of the eye (ocular melanoma).
OR
    B. With metastases as described in 1, 2, or 3:

[[Page 28830]]

    1. Metastases to one or more clinically apparent nodes; that is, 
nodes that are detected by imaging studies (excluding 
lymphoscintigraphy) or by clinical evaluation (palpable).
    2. If the nodes are not clinically apparent, with metastases to 
four or more nodes.
    3. Metastases to adjacent skin (satellite lesions) or distant 
sites (for example, liver, lung, or brain).
OR
    C. Mucosal melanoma.
* * * * *

Part B

* * * * *

113.00 Cancer (Malignant Neoplastic Diseases)

* * * * *

113.00 CANCER (MALIGNANT NEOPLASTIC DISEASES)

    A. What impairments do these listings cover? We use these 
listings to evaluate all cancers (malignant neoplastic diseases), 
except certain cancers associated with human immunodeficiency virus 
(HIV) infection. If you have HIV infection, we use the criteria in 
114.08E to evaluate carcinoma of the cervix, Kaposi sarcoma, 
lymphoma, and squamous cell carcinoma of the anal canal and anal 
margin.
    B. What do we consider when we evaluate cancer under these 
listings? We will consider factors including:
    1. Origin of the cancer.
    2. Extent of involvement.
    3. Duration, frequency, and response to anticancer therapy.
    4. Effects of any post-therapeutic residuals.
    C. How do we apply these listings? We apply the criteria in a 
specific listing to a cancer originating from that specific site.
    D. What evidence do we need?
    1. We need medical evidence that specifies the type, extent, and 
site of the primary, recurrent, or metastatic lesion. When the 
primary site cannot be identified, we will use evidence documenting 
the site(s) of metastasis to evaluate the impairment under 13.27 in 
part A.
    2. For operative procedures, including a biopsy or a needle 
aspiration, we generally need a copy of both the:
    a. Operative note, and
    b. Pathology report.
    3. When we cannot get these documents, we will accept the 
summary of hospitalization(s) or other medical reports. This 
evidence should include details of the findings at surgery and, 
whenever appropriate, the pathological findings.
    4. In some situations, we may also need evidence about 
recurrence, persistence, or progression of the cancer, the response 
to therapy, and any significant residuals. (See 113.00G.)
    E. When do we need longitudinal evidence?
    1. Cancer with distant metastases. Most cancer of childhood 
consists of a local lesion with metastases to regional lymph nodes 
and, less often, distant metastases. We generally do not need 
longitudinal evidence for cancer that has metastasized beyond the 
regional lymph nodes because this cancer usually meets the 
requirements of a listing. Exceptions are for cancer with distant 
metastases that we expect to respond to anticancer therapy. For 
these exceptions, we usually need a longitudinal record of 3 months 
after therapy starts to determine whether the therapy achieved its 
intended effect, and whether this effect is likely to persist.
    2. Other cancers. When there are no distant metastases, many of 
the listings require that we consider your response to initial 
anticancer therapy; that is, the initial planned treatment regimen. 
This therapy may consist of a single modality or a combination of 
modalities; that is, multimodal therapy (see 113.00I3).
    3. Types of treatment.
    a. Whenever the initial planned therapy is a single modality, 
enough time must pass to allow a determination about whether the 
therapy will achieve its intended effect. If the treatment fails, 
the failure often happens within 6 months after treatment starts, 
and there will often be a change in the treatment regimen.
    b. Whenever the initial planned therapy is multimodal, we 
usually cannot make a determination about the effectiveness of the 
therapy until we can determine the effects of all the planned 
modalities. In some cases, we may need to defer adjudication until 
we can assess the effectiveness of therapy. However, we do not need 
to defer adjudication to determine whether the therapy will achieve 
its intended effect if we can make a fully favorable determination 
or decision based on the length and effects of therapy, or the 
residuals of the cancer or therapy (see 113.00G).
    F. How do we evaluate impairments that do not meet one of the 
cancer listings?
    1. These listings are only examples of cancers that we consider 
severe enough to result in marked and severe functional limitations. 
If your severe impairment(s) does not meet the criteria of any of 
these listings, we must also consider whether you have an 
impairment(s) that meets the criteria of a listing in another body 
system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. (See Sec. Sec.  404.1526 
and 416.926 of this chapter.) If your impairment(s) does not meet or 
medically equal a listing, we will also consider whether you have an 
impairment(s) that functionally equals the listings. (See Sec.  
416.926a of this chapter.) We use the rules in Sec.  416.994a of 
this chapter when we decide whether you continue to be disabled.
    G. How do we consider the effects of anticancer therapy?
    1. How we consider the effects of anticancer therapy under the 
listings. In many cases, cancers meet listing criteria only if the 
therapy is not effective and the cancer persists, progresses, or 
recurs. However, as explained in the following paragraphs, we will 
not delay adjudication if we can make a fully favorable 
determination or decision based on the evidence in the case record.
    2. Effects can vary widely.
    a. We consider each case on an individual basis because the 
therapy and its toxicity may vary widely. We will request a specific 
description of the therapy, including these items:
    i. Drugs given.
    ii. Dosage.
    iii. Frequency of drug administration.
    iv. Plans for continued drug administration.
    v. Extent of surgery.
    vi. Schedule and fields of radiation therapy.
    b. We will also request a description of the complications or 
adverse effects of therapy, such as the following:
    i. Continuing gastrointestinal symptoms.
    ii. Persistent weakness.
    iii. Neurological complications.
    iv. Cardiovascular complications.
    v. Reactive mental disorders.
    3. Effects of therapy may change. The severity of the adverse 
effects of anticancer therapy may change during treatment; 
therefore, enough time must pass to allow us to evaluate the 
therapy's effect. The residual effects of treatment are temporary in 
most instances; however, on occasion, the effects may be disabling 
for a consecutive period of at least 12 months. In some situations, 
very serious adverse effects may interrupt and prolong multimodal 
anticancer therapy for a continuous period of almost 12 months. In 
these situations, we may determine there is an expectation that your 
impairment will preclude you from engaging in any age-appropriate 
activities for at least 12 months.
    4. When the initial anticancer therapy is effective. We evaluate 
any post-therapeutic residual impairment(s) not included in these 
listings under the criteria for the affected body system. We must 
consider any complications of therapy. When the residual 
impairment(s) does not meet a listing, we must consider whether it 
medically equals a listing, or, as appropriate, functionally equals 
the listings.
    H. How long do we consider your impairment to be disabling?
    1. In some listings, we specify that we will consider your 
impairment to be disabling until a particular point in time (for 
example, until at least 12 months from the date of transplantation). 
We may consider your impairment to be disabling beyond this point 
when the medical and other evidence justifies it.
    2. When a listing does not contain such a specification, we will 
consider an impairment(s) that meets or medically equals a listing 
in this body system to be disabling until at least 3 years after 
onset of complete remission. When the impairment(s) has been in 
complete remission for at least 3 years, that is, the original tumor 
or a recurrence (or relapse) and any metastases have not been 
evident for at least 3 years, the impairment(s) will no longer meet 
or medically equal the criteria of a listing in this body system.
    3. Following the appropriate period, we will consider any 
residuals, including residuals of the cancer or therapy (see 
113.00G), in determining whether you are disabled. If you have a 
recurrence or relapse of your cancer, your impairment may meet or 
medically equal one of the listings in this body system again.
    I. What do we mean by the following terms?

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    1. Anticancer therapy means surgery, radiation, chemotherapy, 
hormones, immunotherapy, or bone marrow or stem cell 
transplantation. When we refer to surgery as an anticancer 
treatment, we mean surgical excision for treatment, not for 
diagnostic purposes.
    2. Metastases means the spread of cancer cells by blood, lymph, 
or other body fluid. This term does not include the spread of cancer 
cells by direct extension of the cancer to other tissues or organs.
    3. Multimodal therapy means anticancer therapy that is a 
combination of at least two types of treatment given in close 
proximity as a unified whole and usually planned before any 
treatment has begun. There are three types of treatment modalities: 
Surgery, radiation, and systemic drug therapy (chemotherapy, hormone 
therapy, and immunotherapy or biological modifier therapy). Examples 
of multimodal therapy include:
    a. Surgery followed by chemotherapy or radiation.
    b. Chemotherapy followed by surgery.
    c. Chemotherapy and concurrent radiation.
    4. Persistent means the planned initial anticancer therapy 
failed to achieve a complete remission of your cancer; that is, your 
cancer is evident, even if smaller, after the therapy has ended.
    5. Progressive means the cancer becomes more extensive after 
treatment; that is, there is evidence that your cancer is growing 
after you have completed at least half of your planned initial 
anticancer therapy.
    6. Recurrent or relapse means the cancer that was in complete 
remission or entirely removed by surgery has returned.
    J. Can we establish the existence of a disabling impairment 
prior to the date of the evidence that shows the cancer satisfies 
the criteria of a listing? Yes. We will consider factors such as:
    1. The type of cancer and its location.
    2. The extent of involvement when the cancer was first 
demonstrated.
    3. Your symptoms.
    K. How do we evaluate specific cancers?
    1. Lymphoma.
    a. We provide criteria for evaluating lymphomas that are 
disseminated or have not responded to anticancer therapy in 113.05.
    b. Lymphoblastic lymphoma is treated with leukemia-based 
protocols, so we evaluate this type of cancer under 113.06.
    2. Leukemia.
    a. Acute leukemia. The initial diagnosis of acute leukemia, 
including the accelerated or blast phase of chronic myelogenous 
(granulocytic) leukemia, is based on definitive bone marrow 
examination. Additional diagnostic information is based on 
chromosomal analysis, cytochemical and surface marker studies on the 
abnormal cells, or other methods consistent with the prevailing 
state of medical knowledge and clinical practice. Recurrent disease 
must be documented by peripheral blood, bone marrow, or 
cerebrospinal fluid examination, or by testicular biopsy. The 
initial and follow-up pathology reports should be included.
    b. Chronic myelogenous leukemia (CML). We need a diagnosis of 
CML based on documented granulocytosis, including immature forms 
such as differentiated or undifferentiated myelocytes and 
myeloblasts, and a chromosomal analysis that demonstrates the 
Philadelphia chromosome. In the absence of a chromosomal analysis, 
or if the Philadelphia chromosome is not present, the diagnosis may 
be made by other methods consistent with the prevailing state of 
medical knowledge and clinical practice. The requirement for CML in 
the accelerated or blast phase is met in 113.06B if laboratory 
findings show the proportion of blast (immature) cells in the 
peripheral blood or bone marrow is 10 percent or greater.
    c. Juvenile chronic myelogenous leukemia (JCML). JCML is a rare, 
Philadelphia-chromosome-negative childhood leukemia that is 
aggressive and clinically similar to acute myelogenous leukemia. We 
evaluate JCML under 113.06A.
    d. Elevated white cell count. In cases of chronic leukemia 
(either myelogenous or lymphocytic), an elevated white cell count, 
in itself, is not a factor in determining the severity of the 
impairment.
    3. Malignant solid tumors. The tumors we consider under 113.03 
include the histiocytosis syndromes except for solitary eosinophilic 
granuloma. We do not evaluate thyroid cancer (see 113.09), 
retinoblastomas (see 113.12), primary central nervous system (CNS) 
cancers (see 113.13), neuroblastomas (see 113.21), or malignant 
melanoma (see 113.29) under this listing.
    4. Primary central nervous system (CNS) cancers. We use the 
criteria in 113.13 to evaluate cancers that originate within the CNS 
(that is, brain and spinal cord cancers).
    a. The CNS cancers listed in 113.13A are highly malignant and 
respond poorly to treatment, and therefore we do not require 
additional criteria to evaluate them. We do not list pituitary gland 
cancer (for example, pituitary gland carcinoma) in 113.13A, although 
this CNS cancer is highly malignant and responds poorly to 
treatment. We evaluate pituitary gland cancer under 113.13A and do 
not require additional criteria to evaluate it.
    b. We consider a CNS tumor to be malignant if it is classified 
as Grade II, Grade III, or Grade IV under the World Health 
Organization (WHO) classification of tumors of the CNS (WHO 
Classification of Tumours of the Central Nervous System, 2007).
    c. We evaluate benign (for example, WHO Grade I) CNS tumors 
under 111.05. We evaluate metastasized CNS cancers from non-CNS 
sites under the primary cancers (see 113.00C). We evaluate any 
complications of CNS cancers, such as resultant neurological or 
psychological impairments, under the criteria for the affected body 
system.
    5. Retinoblastoma. The treatment for bilateral retinoblastoma 
usually results in a visual impairment. We will evaluate any 
resulting visual impairment under 102.02.
    6. Melanoma. We evaluate malignant melanoma that affects the 
skin (cutaneous melanoma), eye (ocular melanoma), or mucosal 
membranes (mucosal melanoma) under 113.29. We evaluate melanoma that 
is not malignant that affects the skin (benign melanocytic tumor) 
under the listings in 108.00 or other affected body systems.
    L. How do we evaluate cancer treated by bone marrow or stem cell 
transplantation, including transplantation using stem cells from 
umbilical cord blood? Bone marrow or stem cell transplantation is 
performed for a variety of cancers. We require the transplantation 
to occur before we evaluate it under these listings. We do not need 
to restrict our determination of the onset of disability to the date 
of transplantation (113.05 or 113.06). We may be able to establish 
an earlier onset date of disability due to your transplantation if 
the evidence in your case record supports such a finding.
    1. Acute leukemia (including all types of lymphoblastic 
lymphomas and JCML) or accelerated or blast phase of CML. If you 
undergo bone marrow or stem cell transplantation for any of these 
disorders, we will consider you to be disabled until at least 24 
months from the date of diagnosis or relapse, or at least 12 months 
from the date of transplantation, whichever is later.
    2. Lymphoma or chronic phase of CML. If you undergo bone marrow 
or stem cell transplantation for any of these disorders, we will 
consider you to be disabled until at least 12 months from the date 
of transplantation.
    3. Evaluating disability after the appropriate time period has 
elapsed. We consider any residual impairment(s), such as 
complications arising from:
    a. Graft-versus-host (GVH) disease.
    b. Immunosuppressant therapy, such as frequent infections.
    c. Significant deterioration of other organ systems.
    113.01 Category of Impairments, Cancer (Malignant Neoplastic 
Diseases)
    113.03 Malignant solid tumors. Consider under a disability:
    A. For 24 months from the date of initial diagnosis. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system.
OR
    B. For 24 months from the date of recurrence of active disease. 
Thereafter, evaluate any residual impairment(s) under the criteria 
for the affected body system.
    113.05 Lymphoma (excluding all types of lymphoblastic 
lymphomas--113.06). (See 113.00K1.)
    A. Non-Hodgkin lymphoma (including Burkitt's and anaplastic 
large cell), with either 1 or 2:
    1. Bone marrow, brain, spinal cord, liver, or lung involvement 
at initial diagnosis. Consider under a disability for 24 months from 
the date of diagnosis. Thereafter, evaluate under 113.05A2, or any 
residual impairments(s) under the criteria for the affected body 
system.
    2. Persistent or recurrent following initial anticancer therapy.
OR
    B. Hodgkin lymphoma, with either 1 or 2:
    1. Bone marrow, brain, spinal cord, liver, or lung involvement 
at initial diagnosis. Consider under a disability for 24 months from 
the date of diagnosis. Thereafter, evaluate under 113.05B2, or any 
residual impairment(s) under the criteria for the affected body 
system.
    2. Persistent or recurrent following initial anticancer therapy.

[[Page 28832]]

OR
* * * * *
OR
    D. Mantle cell lymphoma.
    113.06 Leukemia. (See 113.00K2.)
    A. Acute leukemia (including all types of lymphoblastic 
lymphomas and juvenile chronic myelogenous leukemia (JCML)). 
Consider under a disability until at least 24 months from the date 
of diagnosis or relapse, or at least 12 months from the date of bone 
marrow or stem cell transplantation, whichever is later. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system.
OR
    B. * * *
    1. Accelerated or blast phase (see 113.00K2b). Consider under a 
disability until at least 24 months from the date of diagnosis or 
relapse, or at least 12 months from the date of bone marrow or stem 
cell transplantation, whichever is later. Thereafter, evaluate any 
residual impairment(s) under the criteria for the affected body 
system.
* * * * *
    113.12 Retinoblastoma.
* * * * *
    B. Persistent or recurrent following initial anticancer therapy.
* * * * *
    113.13 Nervous system. (See 113.00K4.) Primary central nervous 
system (CNS; that is, brain and spinal cord) cancers, as described 
in A, B, or C:
    A. Glioblastoma multiforme, ependymoblastoma, and diffuse 
intrinsic brain stem gliomas (see 113.00K4a).
    B. Any Grade III or Grade IV CNS cancer (see 113.00K4b), 
including astrocytomas, sarcomas, and medulloblastoma and other 
primitive neuroectodermal tumors (PNETs).
    C. Any primary CNS cancer, as described in 1 or 2:
    1. Metastatic.
    2. Progressive or recurrent following initial anticancer 
therapy.
* * * * *
    113.29 Malignant melanoma (including skin, ocular, or mucosal 
melanomas), as described in either A, B, or C:
    A. Recurrent (except an additional primary melanoma at a 
different site, which is not considered to be recurrent disease) 
following either 1 or 2:
    1. Wide excision (skin melanoma).
    2. Enucleation of the eye (ocular melanoma).
OR
    B. With metastases as described in 1, 2, or 3:
    1. Metastases to one or more clinically apparent nodes; that is, 
nodes that are detected by imaging studies (excluding 
lymphoscintigraphy) or by clinical evaluation (palpable).
    2. If the nodes are not clinically apparent, with metastases to 
four or more nodes.
    3. Metastases to adjacent skin (satellite lesions) or distant 
sites (for example, liver, lung, or brain).
OR
    C. Mucosal melanoma.
* * * * *

[FR Doc. 2015-11923 Filed 5-19-15; 8:45 am]
 BILLING CODE 4191-02-P