Under title XVI of the Act, we provide for Supplemental Security Income (SSI) payments on the basis of disability if you are disabled and have limited income and resources.

How Do We Define Disability?

Under both the title II and title XVI programs, disability must be the result of any medically determinable physical or mental impairment or combination of impairments that is expected to result in death or which has lasted or can be expected to last for a continuous period of at least 12 months. Our definitions of disability are shown in the following table:
Disability means you have a medically If you file a claim under * * And you are * * * determinable * impairment(s) as described above and that results in * * * title II...................... an adult or a the inability to do child. any substantial gainful activity (SGA).
title XVI..................... an individual age the inability to do 18 or older. any SGA. title XVI..................... an individual marked and severe under age 18. functional limitations. How Do We Decide Whether You Are Disabled?

If you are seeking benefits under title II of the Act, or if you are an adult seeking benefits under title XVI of the Act, we use a fivestep ``sequential evaluation process'' to decide whether you are disabled. We describe this fivestep process in our regulations at Sec. Sec. 404.1520 and 416.920. We follow the five steps in order and stop as soon as we can make a determination or decision. The steps are:

1. Are you working and is the work you are doing substantial gainful activity? If you are working and the work you are doing is substantial gainful activity, we will find that you are not disabled, regardless of your medical condition or your age, education, and work experience. If you are not, we will go on to step 2.

2. Do you have a ``severe'' impairment? If you do not have an impairment or combination of impairments that significantly limits your physical or mental ability to do basic work activities, we will find that you are not disabled. If you do, we will go on to step 3.

3. Do you have an impairment(s) that meets or medically equals the severity of an impairment in the listings? If you do, and the impairment(s) meets the duration requirement, we will find that you are disabled. If you do not, we will go on to step 4.

4. Do you have the residual functional capacity to do your past relevant work? If you do, we will find that you are not disabled. If you do not, we will go on to step 5.

5. Does your impairment(s) prevent you from doing any other work that exists in significant numbers in the
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national economy, considering your residual functional capacity, age, education, and work experience? If it does, and it meets the duration requirement, we will find that you are disabled. If it does not, we will find that you are not disabled.

We use a different sequential evaluation process for children who apply for payments based on disability under title XVI of the Act. We describe that sequential evaluation process in Sec. 416.924 of our regulations. If you are already receiving benefits, we also use a different sequential evaluation process when we decide whether your disability continues. See Sec. Sec. 404.1594, 416.924, 416.994, and 416.994a of our regulations. However, all of these processes include steps at which we consider whether your impairment meets or medically equals one of our listings.

What Are the Listings?

The listings are examples of impairments that we consider severe enough to prevent you as an adult from doing any gainful activity. If you are a child seeking SSI benefits based on disability, the listings describe impairments that we consider severe enough to result in marked and severe functional limitations. Although the listings are contained only in appendix 1 to subpart P of part 404 of our regulations we incorporate them by reference in the SSI program in Sec. 416.925 of our regulations, and apply them to claims under both title II and title XVI of the Act.

How Do We Use the Listings?

The listings are in two parts. There are listings for adults (part A) and for children (part B). If you are an individual age 18 or over, we apply the listings in part A when we assess your claim, and we do not use the listings in part B.

If you are an individual under age 18, we first use the criteria in part B of the listings. If the listings in part B do not apply, and the specific disease process(es) has a similar effect on adults and children, we then use the criteria in part A. (See Sec. Sec. 404.1525 and 416.925.)

If your impairment(s) does not meet any listing, we will also consider whether it medically equals any listing; that is, whether it is as medically severe as an impairment in the listings. (See Sec. Sec. 404.1526 and 416.926.)
What if You Do Not Have an Impairment(s) That Meets or Medically Equals a Listing?

We use the listings only to decide that individuals are disabled or that they are still disabled. We will not deny your claim because your impairment(s) does not meet or medically equal a listing. If you are not doing work that is substantial gainful activity, and you have a severe impairment(s) that does not meet or medically equal any listing, we may still find you disabled based on other rules in the ``sequential evaluation process'' described above. Likewise, we will not decide that your disability has ended only because your impairment(s) does not meet or medically equal a listing.

Also, when we conduct reviews to determine whether your disability continues, we will not find that your disability has ended because we have changed a listing. Our regulations explain that, when we change our listings, we continue to use our prior listings when we review your case, if you had qualified for disability benefits or SSI payments based on our determination or decision that your impairment(s) met or medically equaled a listing. In these cases, we determine whether you have experienced medical improvement, and if so, whether the medical improvement is related to the ability to work. If your condition(s) has medically improved so that you no longer meet or medically equal the prior listing, we evaluate your case further to determine whether you are currently disabled. We may find that you are currently disabled, depending on the full circumstances of your case. See Sec. Sec. 404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a child who is eligible for SSI payments, we follow a similar rule when we decide whether you have experienced medical improvement in your condition(s). See Sec. 416.994a(b)(2).
Why Are We Revising the Listings for Malignant Neoplastic Diseases?

We are revising these listings to update our medical criteria for evaluating malignant neoplastic diseases and to provide more information about how we evaluate such diseases. On April 24, 2002, we published final rules in the Federal Register (67 FR 20018) that included technical revisions to some of the listings for malignant neoplastic diseases. Prior to this, we last published final rules making comprehensive revisions to the listings for malignant neoplastic diseases in the Federal Register on December 6, 1985 (50 FR 50068). Because we have not comprehensively revised the listings for this body system since 1985, we believe that we need to update the rules. What Do We Mean by ``Final Rules'' and ``Prior Rules''?

Even though these rules will not go into effect until 30 days after publication of this notice, for clarity, we refer to the changes we are making here as the ``final rules'' and to the rules that will be changed by these final rules as the ``prior rules.''

When Will We Start To Use These Final Rules?

We will start to use these final rules on their effective date. We will continue to use our prior rules until the effective date of these final rules. When the final rules become effective, we will apply them to new applications filed on or after the effective date of these rules and to claims pending before us, as we describe below.

As is our usual practice when we make changes to our regulations, we will apply these final rules on or after their effective date when we make a determination or decision, including those claims in which we make a determination or decision after remand to us from a Federal court. With respect to claims in which we have made a final decision, and that are pending judicial review in Federal court, we expect that the court's review of the Commissioner's final decision would be made in accordance with the rules in effect at the time of the
administrative law judge's (ALJ) decision, if the ALJ's decision is the final decision of the Commissioner. If the court determines that the Commissioner's final decision is not supported by substantial evidence, or contains an error of law, we would expect that the court would reverse the final decision, and remand the case for further administrative proceedings pursuant to the fourth sentence of section 205(g) of the Act, except in those few instances in which the court determines that it is appropriate to reverse the final decision and award benefits without remanding the case for further administrative proceedings. In those cases decided by a court after the effective date of the rules, where the court reverses the Commissioner's final decision and remands the case for further administrative proceedings, on remand, we will apply the provisions of these final rules to the entire period at issue in the claim.

How Long Will These Final Rules Be Effective?

These rules will no longer be effective 5 years after the date on which they become effective, unless we extend them or revise and issue them again.
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Why Are We Not Publishing Final Rules for Evaluating Hematological Disorders in This Notice?

The public comments we received on the NPRM raised significant issues about the proposed listings for some of the hematological disorders, and we have not finished resolving these issues. The public comments did not raise similar issues with respect to the listings for malignant neoplastic diseases. Therefore, we are issuing these final regulations to implement changes to the listings for malignant neoplastic diseases, and we summarize and respond here only to the significant public comments that we received about the proposed changes regarding those diseases.

As noted above, we are publishing separately in today's edition of the Federal Register a notice withdrawing the proposed rules for the hematological disorders listings. We plan to issue a new NPRM for the hematological disorders listings at a later date.
What General Changes Are We Making That Affect Both the Adult and Childhood Listings for Malignant Neoplastic Diseases?

To present the listings in a more logical order, and make them easier to use, we are:

13.00 Malignant Neoplastic Diseases

We are expanding and reorganizing the introductory text to these listings to provide additional guidance and reflect the new listings. The following is a detailed explanation of this material.

13.00AWhat Impairments Do These Listings Cover?

In this section, we explain that we use these listings to evaluate all malignant neoplasms, except certain neoplasms associated with human immunodeficiency virus (HIV) infection. We use the criteria in listing 14.08E to evaluate carcinoma of the cervix, Kaposi's sarcoma, lymphoma, and squamous cell carcinoma of the anus if you also have HIV infection. 13.00BWhat Do We Consider When We Evaluate Malignant Neoplastic Diseases Under These Listings?

This section corresponds to prior 13.00A, ``Introduction.'' For clarity, we are using the phrase ``origin of the malignancy'' instead of the prior language, ``the site of the lesion, the histogenesis of the tumor'' to describe one of the factors we consider when we evaluate malignant neoplastic diseases. We also changed the phrase ``apparent adequacy and response to therapy'' in the prior section to ``[r]esponse to antineoplastic therapy'' to eliminate any misunderstanding concerning who can make judgments about the appropriateness of the treatment regimen. ``Apparent adequacy'' was intended to mean effectiveness of the therapy. Judgments about its appropriateness must be left entirely to the treating source. We added the word ``antineoplastic'' to be consistent with the language in the listing criteria. We also specifically identify the types of antineoplastic therapy referred to in the listings.

13.00CHow Do We Apply the Listings?

In this section, we explain that we apply the criteria in a specific listing to a malignancy originating from that specific site.

In this section of the NPRM (66 FR at 59321), we stated that metastatic carcinoma to the brain or spinal cord was an exception to the guidance above. We received a public comment questioning this exception. In response to this comment, we determined that this exception was unnecessary and have removed it. We will evaluate metastatic carcinoma to the brain or spinal cord under the site of origin for the primary tumor or, if this is unknown, under final listing 13.27.

13.00DWhat Evidence Do We Need?

We are expanding the guidance in prior 13.00B, ``Documentation,'' by:

13.00EWhen Do We Need Longitudinal Evidence?

We are incorporating and expanding the guidance in the fourth paragraph of prior 13.00C, ``Evaluation.'' We explain when we need longitudinal evidence, and the time period such evidence should cover. We also explain when we may need to defer adjudication.
13.00FHow Do We Evaluate Impairments That Do Not Meet One of the Malignant Neoplastic Diseases Listings?

This paragraph corresponds to the first sentence in the second paragraph of prior 13.00D, ``Effects of Therapy.'' We state our basic adjudicative principle that, if your impairment(s) does not meet or medically equal the requirements of a listing, we will continue the sequential evaluation process to determine whether you are disabled. [[Page 67021]]

13.00GHow Do We Consider the Effects of Therapy?

We are reorganizing the guidance in prior 13.00D, ``Effects of Therapy.'' In final 13.00G2a, we are adding ``extent of surgery'' and ``schedule and fields of radiation therapy'' to the list of the elements of therapy for which we will request a description noted in the second paragraph of prior 13.00D. In final 13.00G2b, we are adding ``neurological complications'' and ``cardiovascular complications'' to the list of examples of complications or adverse effects for which we will request a description. We are also clarifying that we will not delay adjudication to determine whether the therapy has achieved its intended effect if we can make a fully favorable determination or decision based on the evidence in the case record.
13.00HHow Long Do We Consider Your Impairment To Be Disabling?

We are incorporating and expanding the guidance contained in the third paragraph of prior 7.00E, ``Acute leukemia,'' and the fifth paragraph of prior 13.00C, ``Evaluation.'' In some of the listings, we specify that we consider an impairment to be disabling until a particular point in time; for example, at least 18 months from the date of diagnosis. If you have an impairment(s) that meets or equals a listing in this body system that does not contain such a specification, we provide that we will consider the impairment(s) to be disabling until at least 3 years after onset of complete remission. We also explain what we do when the appropriate time period has passed.

For those listings in which we specify that the impairment is considered disabling until a particular point in time, such as listing 13.28, the beginning date specified is not related to the onset date. We can establish an earlier onset date if the evidence in your case record supports the earlier onset date, as we explain in final 13.00J. 13.00IWhat Do These Terms in the Listings Mean?

We are revising the first two paragraphs and the first sentence of the third paragraph of prior 13.00C, ``Evaluation,'' and providing additional definitions. The prior section contained an adjudicative definition of ``distant metastases'' and ``metastases beyond the regional lymph nodes.'' We are not retaining this definition because our use of these terms in the final listings is consistent with current clinical practice. We are also adding definitions in order to differentiate between the terms ``inoperable'' and ``unresectable.'' 13.00JCan We Establish the Existence of a Disabling Impairment Prior to the Date of the Evidence That Shows the Malignancy Satisfies the Criteria of a Listing?

This section corresponds to prior 13.00E, ``Onset.'' We are making no substantive changes.
13.00KHow Do We Evaluate Specific Malignant Neoplastic Diseases?

We are incorporating and clarifying prior 7.00E, ``Acute leukemia,'' and the last sentence of the third paragraph in prior 13.00C, ``Evaluation,'' and providing guidance for evaluating additional malignant neoplastic disorders. The following is a detailed discussion of the information provided.

13.00K1Lymphoma

In paragraphs K1a and K1b of this section, we discuss the evaluation of low grade or indolent (nonaggressive) lymphomas. We explain that we may defer adjudication of these cases for an appropriate period after the initiation of therapy to determine whether the therapy will achieve its intended effect. We do not specify a particular time for this deferral because it will vary from case to case. We also explain that changes in therapy based solely on patient or physician preference are not indicative of a failure to stabilize the disease. We also explain how the disease should be evaluated when stability has been achieved.

Final paragraphs 13.00K1a and 13.00K1b reflect nonsubstantive editorial corrections made to the corresponding proposed paragraphs in the NPRM (66 FR at 59322). Proposed paragraph K1a referred to indolent lymphoma. We added a reference to low grade lymphoma to final paragraph K1a to be consistent with the listing language. We also added a reference to low grade or indolent lymphoma in final paragraph K1b for clarity.

We have not retained the last sentence of the third paragraph of prior 13.00C, ``Evaluation.'' This sentence stated, ``In the evaluation of lymphomas, the tissue type and site of involvement are not necessarily indicators of the degree of impairment.'' We do not believe this guidance provided useful information for applying the criteria in final listing 13.05.

In paragraph K1c, we provide that Hodgkin's disease that recurs more than 12 months after completing initial antineoplastic therapy will be evaluated as a new disease rather than as a recurrence. 13.00K2Leukemia

In paragraph K2a, we expand the guidance in the first paragraph of prior 7.00E, ``Acute leukemia,'' to indicate sources of additional diagnostic information. We clarify that recurrent disease must be documented by peripheral blood, bone marrow, or cerebrospinal fluid examination. We also clarify that the initial and followup pathology reports should be included.

In paragraph K2b, we provide guidance on documenting chronic myelogenous leukemia (CML). We have not included in this paragraph the guidance in the second paragraph of prior 7.00E, which provided that the acute phase of CML should be considered under the requirements for acute leukemia. Instead, we have provided a separate listing for the acute phase (more appropriately called the accelerated or blast phase) of CML, final listing 13.06B1, that uses the same criteria as the listing for acute leukemia (final listing 13.06A).

In paragraph K2c, we provide guidance for documenting and evaluating chronic lymphocytic leukemia (CLL). Consistent with our effort to eliminate reference listings, this guidance incorporates the crossreferences from prior listing 7.12 that are appropriate for evaluating CLL.

In paragraph K2d, we explain that, in cases of chronic leukemia (either myelogenous or lymphocytic), an elevated white cell count, in itself, is not ordinarily a factor in determining the severity of the impairment.

13.00K3Macroglobulinemia or Heavy Chain Disease

This section replaces prior listing 7.14, which was a reference listing. We are making no substantive changes in how we evaluate these disorders.

13.00K4Bilateral Primary Breast Cancer

We are clarifying the statement in prior listing 13.09D, ``bilateral breast carcinoma, synchronous or metachronous is usually primary in each breast'' (emphasis added) by removing the suggestion that there are exceptions to this rule. See the discussion of final listing 13.10B, below.

13.00K5Carcinomainsitu

In this section, we explain that this type of carcinoma usually responds to treatment and is not included when we use the term ``carcinoma'' in these listings.
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13.00K6Brain Tumors

In this section, we explain that malignant tumors are evaluated under final listing 13.13, while benign tumors continue to be evaluated under listing 11.05. We also explain that we evaluate any complications of malignant brain tumors, such as resultant neurological or psychological impairments, under the criteria for the affected body system.
13.00LHow Do We Evaluate Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation?

In paragraphs L1 and L2, we discuss how long we consider you disabled if you have leukemia, lymphoma, or multiple myeloma and you undergo bone marrow or stem cell transplantation.

In paragraph L3, we provide that any other malignant neoplastic diseases treated with bone marrow or stem cell transplantation must be evaluated under final listing 13.28, regardless of whether there is another listing that addresses that impairment. We explain that under final listing 13.28, the length of time we will consider you disabled will depend on whether you undergo allogeneic or autologous transplantation. We also define ``allogeneic'' and ``autologous'' in paragraphs L3a and L3b.

In paragraph L4, we discuss some of the factors we consider when we evaluate any residual impairment(s) that results from transplantation. How Are We Changing the Listings for Evaluating Malignant Neoplastic Diseases in Adults?
13.01Category of Impairments, Malignant Neoplastic Diseases

We are removing prior listing 13.15, ``Abdomen,'' because disorders covered by this listing can be evaluated under other final listings. Prior listings 13.15A, ``Generalized carcinomatosis,'' and 13.15C, ``Ascites with demonstrated malignant cells,'' represent malignancies that have spread to the abdomen from another site. We will evaluate these conditions under final listing 13.27, ``Primary site unknown after appropriate search for primary.'' We will evaluate
``Retroperitoneal cellular sarcoma not controlled by prescribed therapy,'' the impairment in prior listing 13.15B, under final listing 13.04, ``Soft tissue sarcoma.''

In the final listings, we:

The following is a detailed explanation of the final listings. Listing 13.02Soft Tissue Tumors of the Head and Neck (Except Salivary Glands13.06and Thyroid Gland13.07)

This listing corresponds to prior listing 13.02, ``Head and neck.'' We are revising the listing heading to ensure that only tumors of the soft tissue of the head and neck are considered under this listing. This change allows us to delete the last two exceptions in the prior heading (orbit or temporal fossa), as these are not soft tissue tumors. In response to a comment, we are also removing prior listing 13.02E, ``Epidermoid carcinoma occurring in the pyriform sinus or posterior third of the tongue,'' as these conditions can be evaluated under other sections of the final listing. We had proposed to evaluate epidermoid carcinoma occurring in the pyriform sinus under proposed listing 13.02E. We explain our reasons for this change in more detail in the public comments section of this preamble.

Final listing 13.02A is substantively the same as prior listing 13.02A. We are updating the terminology to reflect the definitions used in the final listings.

In final listing 13.02B, which corresponds to prior listing 13.02B, we are replacing ``[n]ot controlled by prescribed therapy'' with ``[p]ersistent disease following initial multimodal antineoplastic therapy'' to clarify our intent.

Final listing 13.02C corresponds to prior listing 13.02C. We are replacing ``after radical surgery or irradiation'' with ``following initial antineoplastic therapy'' to recognize that other therapeutic modalities may be used. We are also excluding local vocal cord recurrences, because these recurrences have a good response to therapy.

Final listing 13.02D corresponds to prior listing 13.02D. We are making no substantive change.

Final listing 13.02E corresponds to proposed listing 13.02F in the NPRM. As we have already noted, we removed prior and proposed listing 13.02E in response to a comment. Therefore, we are redesignating proposed listing 13.02F as final listing 13.02E. It recognizes the length and debilitating effects of multimodal treatment for soft tissue tumors of the head and neck.

Listing 13.03Skin

We are combining prior listing 13.03, ``Sarcoma of skin,'' and prior listing 13.05, ``Malignant melanoma,'' so that all malignancies originating in the skin are evaluated under this listing. Accordingly, we are revising the heading by removing the reference to sarcoma.

Final listing 13.03A corresponds to prior listing 13.03A, ``Angiosarcoma with metastases to regional lymph nodes or beyond.'' We are expanding the provision to include all skin sarcomas and carcinomas because other skin malignancies of the severity described would also be disabling.

Final listing 13.03B corresponds to prior listing 13.05. We clarify that an additional primary melanoma at a different site is not considered recurrent disease. We are also adding a criterion for palpable nodal metastases. Prior listing 13.05B addressed only metastases to the regional lymph nodes or beyond, and not palpable nodal metastases.

We are moving prior listing 13.03B, ``Mycosis fungoides'' (a type of lymphoma), to final listing 13.05, ``Lymphoma,'' so that all lymphomas will be evaluated under the same listing.

Listing 13.04Soft Tissue Sarcoma

We are updating the heading of prior listing 13.04, ``Sarcoma of soft parts,'' to recognize that ``soft tissue'' is a more common term than ``soft parts.'' We are adding a criterion for regional or distant metastases, final listing 13.04A, to be consistent with the criteria for other malignant neoplastic diseases and to recognize the grave prognosis for these conditions. In final listing 13.04B, we define the prior criterion ``not controlled by prescribed therapy'' similarly to the way we defined it in other listings, such as final listing 13.02B. Listing 13.05Lymphoma (Including Mycosis Fungoides, But Excluding T cell Lymphoblastic Lymphoma13.06)

This listing corresponds to prior listing 13.06. We are changing the heading from ``Lymph nodes'' to ``Lymphoma'' to more accurately reflect the disease. We also provide a crossreference to the explanatory paragraphs in 13.00K1 and 13.00K2c. This listing also replaces prior listing 7.13, ``Lymphomas.''

We evaluated both Hodgkin's disease and nonHodgkin's lymphoma under prior listing 13.06A. We are separating and clarifying the criteria for each of these diseases. Final listing 13.05A provides criteria for evaluating nonHodgkin's lymphoma; final listing 13.05B provides criteria for Hodgkin's disease. For each of these disorders, we clarify the prior criteria by replacing the phrase ``progressive disease not
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controlled by prescribed therapy'' in the prior listing with clearer language.

In the final rules, we are making a minor editorial revision to proposed listing 13.05A2 for clarity. We amended the proposed listing by adding the words ``at least'' between ``from'' and ``the'' in the last sentence to clarify that the individual can be found disabled prior to the date specified in the listing.

In final listing 13.05C, we provide that a lymphoma treated by bone marrow or stem cell transplantation is considered disabling until at least 12 months from the date of transplantation. After this period, we will evaluate any residual impairment(s) under the criteria for the affected body system.

We are removing prior listing 13.06B, ``Metastatic carcinoma in a lymph node (except for epidermoid carcinoma in a lymph node in the neck) where the primary site is not determined after adequate search.'' We will evaluate this impairment under final listing 13.27, ``Primary site unknown after appropriate search for primary.'' We are also removing prior listing 13.06C. We will evaluate epidermoid carcinoma in a lymph node in the neck under final listing 13.02, ``Soft tissue tumors of the head and neck.''

Listing 13.06Leukemia

This final listing replaces prior listing 7.11, ``Acute leukemia,'' and prior listing 7.12, ``Chronic leukemia.''

Final listing 13.06A replaces prior listing 7.11. We provide that acute leukemia (including Tcell lymphoblastic lymphoma) will be considered disabling 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. After the appropriate period, we will evaluate any residual impairment(s) under the criteria for the affected body system.

Under the prior listing, we considered acute leukemia disabling for 2\1/2\ years from the time of the initial diagnosis. We are shortening this period to 2 years because of improvement in the treatment of this disorder. However, as with other final listings, and unlike the prior listing, we permit a longer period when the facts warrant it. We also recognize that a relapse of acute leukemia is as significant as the initial diagnosis.

The criterion for bone marrow or stem cell transplantation in cases of acute leukemia is similar to the transplantation criteria for other diseases. Unlike those diseases, however, we will not reevaluate cases of acute leukemia 12 months after transplantation if that date is earlier than 24 months after onset or relapse. We provide this option for this disease because of the disease course and the high rate of infection and other complications that occur when this disease is treated with bone marrow or stem cell transplantation.

Final listing 13.06B, ``Chronic myelogenous leukemia,'' replaces prior listing 7.12. The prior listing was a reference listing. Rather than replace the entire listing with guidance in the preface, we are providing separate evaluation criteria for CML. Consistent with our guidance in the second paragraph of prior 7.00E, the listing for the accelerated or blast phase of CML is the same as final listing 13.06A.

We are retaining references to the listings that are appropriate for evaluating chronic lymphocytic leukemia in 13.00K2c.
Listing 13.07Multiple Myeloma (Confirmed by Appropriate Serum or Urine Protein Electrophoresis and Bone Marrow Findings)

This listing replaces prior listing 7.16. In this listing, we remove the specific findings in prior listings 7.16AD and substitute the criterion ``[f]ailure to respond or progressive disease following initial antineoplastic therapy.'' Our intent is to clarify that this listing includes all listinglevel manifestations of this disease. We also clarify that we consider multiple myeloma treated with bone marrow or stem cell transplantation to be disabling until at least 12 months from the date of transplantation. After that time, we will evaluate any residual impairment(s) under the criteria for the affected body system. Listing 13.08Salivary Glands

This listing redesignates prior listing 13.07. There are no substantive changes.

Listing 13.09Thyroid Gland

In the NPRM, we proposed to amend current listing 13.08, for malignancies of the thyroid gland, by:

On April 24, 2002, we published final rules in the Federal Register (67 FR 20018, 20026) that made technical revisions to the listings. Those rules added the criterion for anaplastic (undifferentiated) carcinoma and redesignated the criterion in prior listing 13.08 as final listing 13.08B.

In these final rules, we are redesignating prior listing 13.08 as final listing 13.09, and are clarifying the language as indicated in the fourth bullet above.

Listing 13.10Breast

This listing corresponds to prior listing 13.09. In final listing 13.10A, we are amending the criterion in prior listing 13.09B, ``Inflammatory carcinoma,'' by adding other types of locally advanced carcinoma.

In final listing 13.10B, ``Carcinoma with distant metastases,'' we are revising prior listing 13.09D by removing the parenthetical statement ``bilateral breast carcinoma, synchronous or metachronous, is usually primary in each breast.'' Instead, we provide guidance about evaluating bilateral breast cancer in final 13.00K4. As indicated in our discussion of that section, we are clarifying this guidance by removing the suggestion that there are exceptions to this rule.

In final listing 13.10C, which replaces prior listing 13.09C, we are replacing the term ``controlled by prescribed therapy'' used in the prior listing with ``that remits with antineoplastic therapy'' to clarify our intent.

We are removing prior listing 13.09A, ``inoperable carcinoma,'' to avoid confusion about what this term means for this malignancy. We can evaluate cases in which breast cancer is inoperable under other criteria in final listing 13.10. We are also removing prior listing 13.09E, ``Sarcoma with metastases anywhere.'' We will evaluate this impairment under final listing 13.04, ``Soft tissue sarcoma.'' Listing 13.11Skeletal System

This listing replaces prior listing 13.10. We are expanding the listing to include tumors of the mandible that were evaluated under prior listing 13.11. In final listings 13.11A, 13.11B, and 13.11C, we revise prior listing 13.10A to clarify when these tumors are of listinglevel severity. In final listing 13.11D, we provide that we consider all other malignant tumors originating in bone with multimodal antineoplastic therapy to be disabling for 12 months from the date of diagnosis. Consistent with the changes we have made for other listings, any residual impairment(s) will be evaluated under
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the criteria for the affected body system after that period. With this criterion, we recognize the length and debilitating effects of multimodal treatment for these tumors.

Listing 13.12Maxilla, Orbit, or Temporal Fossa

This listing corresponds to prior listing 13.11. As noted above, we evaluate tumors of the mandible under final listing 13.11. Final listings 13.12A and 13.12B reorganize the criteria in prior listings 13.11A and 13.11B by moving the criterion for carcinoma with regional or distant metastases (part of prior listing 13.11B) to final listing 13.12A. We did this so that all tumors of the maxilla, orbit, or temporal fossa with regional or distant metastases would be covered in the same listing. The final listings do not make any substantive changes.

In the NPRM, we inadvertently changed the word ``temporal'' in the heading of current listing 13.11 to ``infratemporal'' in the heading of proposed listing 13.12 (66 FR at 59323). We are correcting the heading in these final rules. Additionally, although we moved the criterion for carcinoma with regional or distant metastases to proposed listing 13.12A, we failed to remove the criterion from proposed listing 13.12B. We are removing the criterion from final listing 13.12B in response to a public comment indicating that retaining the criterion in listing 13.12B was redundant.

In final listing 13.12C, we consolidate the disease sites in prior listings 13.11C, 13.11D, 13.11E, and 13.11F.

Listing 13.13Nervous System

This listing incorporates the criteria for malignant brain tumors from listing 11.05, ``Brain tumors,'' in the neurological body system, and replaces prior listing 13.12, ``Brain or spinal cord.'' We are expanding the listings to include tumors of the spinal cord, spinal nerve roots, and the peripheral nervous system. We are also including tumors of the central nervous system that are not specifically named.

Under final listing 13.13A, we evaluate central nervous system malignant neoplasms; that is, those affecting the brain or spinal cord. In final listing 13.13A1, we list and revise the criteria for the impairments named in prior listing 11.05A. We are revising the reference to medulloblastoma to include other primitive neuroectodermal tumors (PNETs) and to require documented metastases for this type of tumor. Advances in treatment have significantly improved the overall prognosis of this disease, so that, in the absence of metastases, many individuals do well. We can evaluate medulloblastomas or other PNETs that have not metastasized, as well as the malignant brain tumors listed in prior listing 11.05B, under final listing 13.13A2.

We are also adding diffuse intrinsic brain stem gliomas in final listing 13.13A1. We are requiring that the impairment be ``diffuse'' and ``intrinsic'' because progress in medical diagnostic tools has now allowed for effective treatment of individuals with localized brain stem tumors.

In the NPRM, the criteria in proposed listing 13.13A were preceded by the phrase, ``Central nervous system neoplasms (brain and spinal cord), including * * *.'' In final listing 13.13A, we are changing the word ``including'' to the phrase ``as described in 1 or 2'' to be consistent with other listings.

In final listing 13.13B, we provide criteria for evaluating malignant tumors of peripheral nerves and spinal roots.

In the NPRM, we had proposed a listing, listing 13.13C, to correspond to prior listing 13.12A for metastatic carcinoma to brain or spinal cord. In response to a public comment, we have determined that this listing is unnecessary. These malignancies will be evaluated under the criteria for the site of origin, or under listing 13.27 if the primary site is unknown. Therefore, we are removing prior listing 13.12A and proposed listing 13.13C. We are also removing prior listing 13.12B, which was a reference listing.

Listing 13.14Lungs

This listing corresponds to prior listing 13.13. In final listing 13.14A, we consolidate prior listings 13.13A, 13.13B, 13.13D, and 13.13E. This change is consistent with current medical terminology, which no longer distinguishes between the types of nonsmallcell carcinoma.

In the NPRM, proposed listing 13.14A covered metastatic disease to or beyond the mediastinal or subcarinal lymph nodes. A public comment pointed out that this criterion would exclude cases of nonsmallcell carcinomas with metastases to the hilar lymph nodes that had been included under prior listing 13.13E. The comment also indicated that, even when the involved hilar nodes are excised, the prognosis for this disease is unfavorable. In response to this comment, we have revised final listing 13.14A to include metastases to the hilar nodes.

We are redesignating prior listing 13.13C as final listing 13.14B. We are making no substantive changes.

Listing 13.15Pleura or Mediastinum

This listing corresponds to prior listing 13.14. Final listing 13.15A is the same as prior listing 13.14A. In final listing 13.15B, which corresponds to prior listing 13.14C, we provide new language that clarifies the phrase ``not controlled by prescribed therapy'' used in the prior listing.

In the NPRM, the criterion in proposed listing 13.15B1 was ``Metastatic.'' In final listing 13.15B1, we revise this criterion to ``With metastases to or beyond the regional lymph nodes'' to be consistent with the other listings in these rules.

We are removing prior listing 13.14B, ``Malignant tumors, metastatic to pleura.'' We will evaluate this malignancy under final listing 13.27, ``Primary site unknown.''

Listing 13.16Esophagus or Stomach

This listing corresponds to prior listing 13.16. Final listing 13.16A is the same as prior listing 13.16A. In final listing 13.16B, we consolidate prior listings 13.16B through 13.16E to clarify that all of those criteria relate to carcinoma or sarcoma of the stomach. We also provide new language to clarify the phrase ``not controlled by prescribed therapy'' used in prior listing 13.16C.

Listing 13.17Small Intestine

This listing corresponds to prior listing 13.17. In final listing 13.17A, we expand the criterion in prior listing 13.17B, for recurrent malignancies, to indicate that inoperable and unresectable malignancies are also of listinglevel severity. We also provide new language to clarify the phrase ``not controlled by prescribed therapy'' used in prior listing 13.17C. Final listing 13.17B corresponds to prior listing 13.17A, and is substantively unchanged.
Listing 13.18Large Intestine (From Ileocecal Valve to and Including Anal Canal)

This listing corresponds to prior listing 13.18. We are removing the phrase ``carcinoma or sarcoma'' from the heading of this listing because sarcomas of the large intestine are extremely rare. In final listing 13.18A, we consolidate prior listings 13.18A and 13.18C and clarify that these criteria apply to adenocarcinoma. In final listing 13.18B, we provide that squamous cell carcinoma of the anus will not be found to meet the listing unless it is recurrent after surgery. Advances in treatment have made chemotherapy and radiation the treatment of choice for this disorder. However, good results can be achieved through surgery if the preferred treatment is not effective. Final listing
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13.18C is the same as prior listing 13.18B.

Listing 13.19Liver or Gallbladder

This listing corresponds to prior listing 13.19. We are clarifying that the listing applies only to malignancies that originate in the liver, gallbladder, or bile ducts. We evaluate metastases to the liver from other sites under the criteria for the site of origin, or under the criteria of final listing 13.27 when the primary site is unknown. Listing 13.20Pancreas

This listing corresponds to prior listing 13.20. We are not making any substantive changes, other than adding ``inoperable'' conditions to the second listing criterion. We are making this change to reflect the revised definitions used in these listings.

Listing 13.21Kidneys, Adrenal Glands, or Ureters

This listing corresponds to prior listing 13.21. In final listing 13.21A, we expand the criteria of unresectable tumors in prior listing 13.21A to include inoperable and recurrent tumors. Final listing 13.21B consolidates prior listings 13.21B and 13.21C. We are eliminating the modifier ``hematogenous'' used in prior listing 13.21B because metastases by lymphatic spread or by direct extension carry the same poor prognosis.

Listing 13.22Urinary Bladder

This listing corresponds to prior listing 13.22. We are removing prior listing 13.22E, which provided for the evaluation of renal impairment following total cystectomy under the criteria in listing 6.02, because it was a reference listing.

Listing 13.23Cancers of the Female Genital Tract

In this listing, we incorporate and revise prior listings 13.25, ``Uterus,'' 13.26, ``Ovaries,'' 13.28, ``Uterine (Fallopian) tubes,'' and 13.30, ``Vulva.''

In final listings 13.23A, ``Uterus (corpus),'' and 13.23B ``Uterine cervix,'' we replace the prior criteria in listings 13.25B, ``Recurrent after total hysterectomy,'' and 13.25C, ``Total pelvic exenteration,'' with ``Persistent or recurrent following initial antineoplastic therapy.'' With this revision, we recognize changes in treatment for these disorders. In final listing 13.23C, ``Vulva,'' we provide criteria in addition to the criteria for distant metastases used in the prior listing.

We are making several changes in final listing 13.23D, ``Fallopian tubes.'' In final listing 13.23D1, `` Extending to the serosa or beyond,'' we replace the criteria in prior listings 13.28A, ``Unresectable,'' and 13.28B, ``Metastases to regional lymph nodes.'' Tumors extending to the serosa are considered to be unresectable for the purposes of this listing; tumors extending beyond the serosa equate to tumors that have metastasized to the regional lymph nodes. In final listing 13.23D2, we are also adding criteria to evaluate fallopian tube tumors when the initial antineoplastic therapy has not achieved the desired effect.

In final listing 13.23E, ``Ovaries,'' we separate germcell and nongermcell tumors. In final listing 13.23E1, which provides the criteria for evaluating nongermcell tumors, we expand the criteria in prior listing 13.26 to reflect advances in diagnostic techniques and treatment. We provide criteria for evaluating germcell tumors in final listing 13.23E2.

Listing 13.24Prostate Gland

In this listing, which corresponds to prior listing 13.23, we provide new language to clarify the phrase ``not controlled by prescribed therapy'' used in the prior listing.

Listing 13.25Testicles

This listing corresponds to prior listing 13.24. We are removing prior listing 13.24A, for choriocarcinoma because the literature we consulted does not separate choriocarcinoma from other forms of nonseminomatous germcell tumors with regard to staging or treatment. (See 67 FR 19138 for a list of the literature we consulted.) Listing 13.26Penis

This listing corresponds to prior listing 13.29. We have clarified the listing to explicitly include metastases to or beyond the regional lymph nodes.
Listing 13.27Primary Site Unknown After Appropriate Search for Primary

We are providing a listing for the occasional case in which metastases have been appropriately verified but the site of the primary malignancy cannot be determined. The final listing specifically excludes solitary squamous cell carcinoma in the neck, as this type of metastasis is often amenable to treatment.
Listing 13.28Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation

As we have already noted in our discussion of final 13.00L above, final listing 13.28 is a listing for bone marrow or stem cell transplantation in any malignant neoplastic disease other than acute leukemia, CML, lymphoma, or multiple myeloma, which we evaluate under final listings 13.05, 13.06 and 13.07. In final listing 13.28A, we provide that allogeneic transplantation is disabling until at least 12 months from the date of transplantation. In final listing 13.28B, we provide that autologous transplantation is disabling until at least 12 months from the date of the first treatment under the treatment plan that includes transplantation. We use an earlier date to begin the 12 month period for autologous transplantation because the recovery period after this type of transplantation is generally shorter than for allogeneic transplantation. In both cases, we will evaluate any residual impairment(s) after the applicable period under the criteria for the affected body system.
How Are We Changing the Introductory Text to the Listings for Evaluating Malignant Neoplastic Diseases in Children?

113.00 Malignant Neoplastic Diseases

Except for minor changes to refer to children, we are repeating much of the introductory text in 13.00 in the introductory text in 113.00. This is because the same basic rules for establishing and evaluating the existence and severity of malignant neoplastic diseases in adults also apply to children. Because we have already described these provisions under the explanation of 13.00, the following discussions describe only those provisions that are unique to the childhood rules or that require further explanation.
113.00BWhat Do We Consider When We Evaluate Malignant Neoplastic Diseases Under These Listings?

In this section, which is the same as final 13.00B, we replace the guidance in prior 113.00A1.

113.00DWhat Evidence Do We Need?

In this section, we replace and expand prior 113.00B. This section is substantively the same as final 13.00D. We are not including a childhood listing to correspond to final listing 13.27, primary site unknown after appropriate search for primary, because the inability to determine the primary site is an extremely rare occurrence in childhood malignancies. Instead, we indicate that, in these rare situations, we will use final listing 13.27.
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113.00EWhen Do We Need Longitudinal Evidence?

This section is similar to final 13.00E. We are adding a general description of most malignant childhood tumors.
113.00FHow Do We Evaluate Impairments That Do Not Meet One of the Malignant Neoplastic Diseases Listings?

In this section, we repeat the guidance in final 13.00F, but use the definition of disability for children who claim SSI payments. 113.00GHow Do We Consider the Effects of Therapy?

This section replaces prior 113.00A2 and the last paragraph of prior 113.00A. We repeat the guidance in final 13.00G but use the definition of disability for children who claim SSI payments. 113.00HHow Long Do We Consider Your Impairment To Be Disabling?

This section corresponds to final 13.00H. It also replaces prior 113.00D, ``Duration of disability,'' which referred to the specific time periods that we included in prior listings 113.02 and 113.03. Although we do not cite specific listings, we indicate that some listings specify that the impairment should be considered disabling until a particular point in time. In final 113.00H2, we state that, when the listing does not contain such a specification, we will consider an impairment that meets or medically equals the listings in this body system to be disabling until at least 3 years after onset of complete remission. We added this section to ensure consistency between the adult and childhood rules.

113.00IWhat Do These Terms in the Listings Mean?

This section corresponds to final 13.00I. As we explain below, we are retaining our listings for malignant solid tumors. Because of this, there are no listings in part B of these final rules that include the terms ``inoperable'' and ``unresectable.'' Therefore, in these final rules, we revised proposed 113.00I to remove the definitions of those terms.
113.00KHow Do We Evaluate Specific Malignant Neoplastic Diseases?

In this section, we incorporate the discussion in prior 107.00C, ``Acute leukemia,'' and provide guidance for other childhood malignancies. Except for minor changes to refer to children, final 113.00K4, ``Brain Tumors,'' is the same as final 13.00K6. The following is a discussion of the other malignant neoplastic diseases addressed in this section.

113.00K1Lymphoma

In this section, we indicate that final listing 113.05 should not be used for evaluating low grade or indolent lymphomas because they are rare in children. We will evaluate these lymphomas under final listing 13.05. We also indicate that many children with lymphoma are treated according to a longterm protocol that can result in significant adverse medical, social, and emotional consequences. We provide a reference to final 113.00G to evaluate those consequences.

113.00K2Leukemia

In final 113.00K2c, we provide a description of juvenile CML (JCML) and explain that we will evaluate it under final listing 113.06A.

Final 113.00K2d is similar to final 13.00K2d. We did not include a discussion about chronic lymphocytic leukemia, as in final 13.00K2c, because the disorder is extremely rare in children.

113.00K3Malignant Solid Tumors

In this section, we incorporate the guidance in prior 113.00C, ``Malignant solid tumors.'' We have revised the reference to the listing for brain tumors because that listing is now in this body system. As we have added a listing for the thyroid gland, we no longer need guidance in the introductory text explaining how thyroid tumors should be evaluated.

113.00K5Retinoblastoma

In this section, we state that treatment for bilateral retinoblastoma usually results in a visual impairment and that we will evaluate any resulting visual impairment under listing 102.02. 113.00LHow Do We Evaluate Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation?

In this section, we provide the same guidance as in final 13.00L1, 13.00L2, and 13.00L4. We have added JCML to the heading of 13.00L1 to reflect that JCML is included in final listing 113.06A. We do not refer to multiple myeloma in final 113.00L2 because this impairment is not included in the final childhood listings. Multiple myeloma is extremely rare in children.

In the NPRM, we had also proposed a section in part B, similar to final 13.00L3, that contained guidance on how to evaluate bone marrow or stem cell transplantation for other disorders in children. That section, proposed 113.00L3, indicated that malignant neoplastic diseases treated with bone marrow or stem cell transplantation should be evaluated under proposed listing 113.28. Proposed listing 113.28 was one of several listings that we proposed as a replacement for prior listing 113.03, ``Malignant solid tumors.'' As we explain in the public comments section of this preamble, we have decided not to change our prior criteria for malignant solid tumors in these final rules. Therefore, we do not need the guidance we included in proposed section 113.00L3, and we are not including it in these final rules. As we indicate in response to a public comment on bone marrow or stem cell transplantation in chidren, final listing 13.28 can be used in those few cases in which the end of the 2year period provided by final listing 113.03 is earlier than the end of the period that the impairment would be considered disabling based on the bone marrow or stem cell transplantation.
How Are We Changing the Listings for Evaluating Malignant Neoplastic Diseases in Children?
113.01 Category of Impairments, Malignant Neoplastic Diseases

We are redesignating the childhood listings to maintain consistency with the adult rules for those malignancies that are addressed in both the adult and childhood rules. Because of this, the numbers of the final childhood listings are not consecutive.

Listing 113.03Malignant Solid Tumors

This listing corresponds to prior listing 113.03, ``Malignant Solid Tumors.'' We are making minor editorial changes to make the language consistent with that used in other listings and to indicate that, after the appropriate time period has passed, any residual impairment should be evaluated under criteria for the affected body system.

In the NPRM, we proposed removing prior listing 113.03 and providing separate listings for specific types of malignant solid tumors and a listing for malignant neoplastic diseases treated by bone marrow or stem cell transplantation. In response to a comment, we have decided to retain prior listing 113.03 as we further consider how to include solid tumors in children in our listings. Because we are retaining prior listing 113.03 in these final rules, we are not incorporating the proposed listings that would have replaced it: Proposed listing 113.04, ``Soft Tissue Sarcoma (including Ewing's Sarcoma, Primitive Neuroectodermal Tumors (PNETs)''; proposed listing 113.11, ``Osteogenic Sarcoma''; proposed listing 113.13A2,
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for any central nervous system neoplasm progressive or recurrent following initial antineoplastic therapy; proposed listing 113.13B, for peripheral nerve or spinal root neoplasm; proposed listing 113.21B, for Wilms' tumor persistent or recurrent following initial Antineoplastic therapy; proposed listing 113.25, ``TesticlesTumor With Metastatic Disease Progressive of Recurrent Following Initial Chemotherapy''; proposed listing 113.26, ``Germ Cell TumorsGonadal or Extragonadal''; and proposed listing 113.28, ``Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation.''
Listing 113.05Lymphoma (Excluding Tcell Lymphoblastic Lymphoma 113.06)

This listing corresponds to prior listing 113.02, ``Lymphoreticular malignant neoplasms.'' We are revising the listing to make it more consistent with final listing 13.05.

Final listing 113.05A replaces the criteria for nonHodgkin's lymphoma in prior listing 113.02B. Currently, there are several treatment regimens for this disease, and they vary in the amount of time needed to complete them. Many are of sufficiently short duration that the impairment may be disabling for less than 12 months. Due to these advances in treatment, it is no longer appropriate to assume that the impairment will meet the statutory duration requirement. Instead, we will find the impairment disabling under this listing when it is persistent or recurrent following initial antineoplastic therapy. We also clarify that nonHodgkins lymphoma includes Burkitt's and anaplastic large cell.

Final listing 113.05B replaces the criteria for Hodgkin's disease in prior listing 113.02A. With the final criterion, we clarify what we meant by ``progressive disease not controlled by prescribed therapy'' in the prior listing.

In final listing 113.05C, we add a criterion for bone marrow or stem cell transplantation.

Listing 113.06Leukemia

This listing replaces prior listing 107.11, ``Acute leukemia.'' In final listing 113.06A, for ``acute leukemia,'' we also include Tcell lymphoblastic lymphoma and JCML. JCML is an aggressive leukemia that responds poorly to therapy and is, therefore, more appropriately evaluated like an acute leukemia. The criteria in this listing are the same as in final listing 13.06A, and are explained in the discussion of that listing.

In final listing 113.06B, which is the same as final listing 13.06B, we added criteria for evaluating CML other than JCML. Listing 113.09Thyroid Gland

This listing is the same as final listing 13.09 and incorporates the guidance contained in prior 113.00C. The listing criteria define when the malignancy is not controlled by prescribed therapy. Listing 113.12Retinoblastoma

This final listing revises prior listing 113.05. We are removing prior listing 113.05A, for bilateral involvement, because with advances in treatment this malignancy is often treated

FOR FURTHER INFORMATION CONTACT

Martin Sussman, Regulations Officer, Office of Regulations, Social Security Administration, 100 Altmeyer Building, 6401 Security Boulevard, Baltimore, Maryland 212356401, (410) 9651767 or TTY (410) 9665609. For information on eligibility or filing for benefits, call our national tollfree number, 18007721213 or TTY 18003250778, or visit our Internet Web site, Social Security Online, at http://www.socialsecurity.gov/.