This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

51229 

Vol. 74, No. 192 

Tuesday, October 6, 2009 

1 ‘‘Malignant neoplastic disease’’ is commonly 

known as ‘‘cancer.’’ We use both terms 

interchangeably in this document because we 

continue to use the technical medical term in the 

listings. 

2See 69 FR 67018, corrected at 70 FR 15227. 

3This means that we will use these final rules on 

and after their effective date in any case in which 

we make a determination or decision. We expect 

that Federal courts will review our final decisions 

using the rules that were in effect at the time we 

issued the decisions. If a court reverses the 

Commissioner’s final decision and remands a case 

for further administrative proceedings after the 

effective date of these final rules, we will apply 

these final rules to the entire period at issue in the 

decision we make after the court’s remand. 

SMALL BUSINESS ADMINISTRATION 

13 CFR Parts 120 and 124 

RIN 3245–AF64 

Agency Titling Procedure Revision; 

Nomenclature Changes; Correction 

AGENCY: U.S. Small Business 

Administration. 

ACTION: Notice of correcting 

amendment; correction. 

SUMMARY: The U.S. Small Business 

Administration (SBA) published in the 

Federal Register of September 4, 2009, 

a document correcting the titles of 

certain SBA officials. Some sections 

were inadvertently amended and 

another contained an error. This 

document corrects those amendments. 

DATES: Effective on October 6, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Dean R. Koppel, Office of Government 

Contracting, Small Business 

Administration, 409 3rd Street, SW., 

Washington, DC 20416. Tel: (202) 205– 

6460 and e-mail: dean.koppel@sba.gov. 

SUPPLEMENTARY INFORMATION: The SBA 

published a document in the Federal 

Register of August 30, 2007 which 

amended several SBA titles. On 

September 4, 2009, in the Federal 

Register (74 FR 45754), § 120.433; 

§ 120.472 and § 120.473 were 

inadvertently amended. This correction 

removes the amendments to § 120.433; 

§ 120.472 and § 120.473 published on 

September 4, 2009. Additionally, 

§ 124.1008 (a) was identified as 

amended when the reference should 

have been § 124.1008(e). 

In 74 FR 45754 published on 

September 4, 2009, make the following 

corrections. 

§§ 120.433, 120.472 and 120.473 

[Corrected] 

■ 1. On page 45753, in the first column, 

remove the amendments to § 120.433; 

§ 120.472 and § 120.473. 

§ 124.1008 [Corrected] 

■ 2. On page 45754, in the first column, 

correct the amendment to § 124.1008 by 

removing the reference to ‘‘paragraph 

(a)’’ and adding a reference to 

‘‘paragraph (e)’’ in its place. 

Dated: September 29, 2009. 

Joseph G. Jordan, 

Associate Administrator, Office of 

Government Contracting and Business 

Development. 

[FR Doc. E9–24040 Filed 10–5–09; 8:45 am] 

BILLING CODE 8025–01–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 404 

[Docket No. SSA–2007–0066] 

RIN 0960–AG57 

Revised Medical Criteria for Evaluating 

Malignant Neoplastic Diseases 

AGENCY: Social Security Administration. 

ACTION: Final rule. 

SUMMARY: We are revising some of the 

criteria in the Listing of Impairments 

(the listings) that we use to evaluate 

claims involving malignant neoplastic 

diseases (cancer) 1 under titles II and 

XVI of the Social Security Act (Act). The 

revisions reflect our adjudicative 

experience, advances in medical 

knowledge, diagnosis, and treatment, 

and public comments we received in 

response to a Notice of Proposed 

Rulemaking (NPRM). 

DATES: This rule is effective November 

5, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Mark Kuhn, Office of Medical Listings 

Improvement, 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 Web site, Social 

Security Online, at http:// 

www.socialsecurity.gov. 

SUPPLEMENTARY INFORMATION: 

Electronic Version 

The electronic file of this document is 

available on the date of publication in 

the Federal Register at http:// 

www.gpoaccess.gov/fr/index.html. 

Background 

We are revising and making final the 

rules for evaluating malignant 

neoplastic diseases we proposed in an 

NPRM published in the Federal 

Register on April 24, 2008 (73 FR 

22871). The preamble to the NPRM 

discussed the changes from the current 

rules and our reasons for making those 

changes. Since we are largely adopting 

the proposed rules as published, we are 

not repeating that information here. 

Interested readers may refer to the 

preamble to the NPRM, available at 

http://www.regulations.gov. 

We are making a few changes from the 

NPRM as a result of public comments. 

We explain those changes in our 

summary of the public comments and 

our responses later in this preamble. 

Why are we revising the listings for 

malignant neoplastic diseases? 

We developed these final rules as part 

of our ongoing review of the cancer 

body system. When we last revised this 

body system in final rules published on 

November 15, 2004,2 we indicated that 

we would monitor and update the 

listings in this body system as needed. 

When will we use these final rules? 

We will use these final rules 

beginning on their effective date. We 

will continue to use the current listings 

until the date these final rules become 

effective. We will apply the final rules 

to new applications filed on or after the 

effective date of the final rules and to 

claims that are pending on and after the 

effective date.3


CPrice-Sewell on DSKGBLS3C1PROD with RULES
51230 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 

How long will the rules in the 

malignant neoplastic diseases body 

system be in effect? 

We are extending the effective date of 

the malignant neoplastic diseases body 

system in parts A and B of the listings 

until 8 years after the effective date of 

these final rules. The rules will remain 

in effect only until that date unless we 

extend them. We will continue to 

monitor the rules and may revise them 

before the end of the 8-year period. 

Public Comments on the NPRM 

In the NPRM, we provided the public 

with a 60-day comment period, which 

ended on June 27, 2008. We received 

five public comment letters. The 

comments came from a national cancer 

advocacy group, a national group 

representing disability examiners in the 

State agencies that make disability 

determinations for us, a national group 

representing directors of those State 

agencies, and two individual State 

agencies. 

We provide our responses below to 

the significant comments that were 

relevant to this rulemaking. A few of the 

comments were on subjects that were 

not related to the proposed rules. For 

example, commenters suggested 

changes to the introductory text of this 

body system and some suggested that 

we add new listings in sections for 

which we had not proposed rules. Other 

commenters made suggestions that 

involved the steps of our sequential 

evaluation process coming after the 

listing step. Although we read and 

considered these comments, we do not 

summarize or respond to them below 

because they are outside the scope of 

this rulemaking proceeding. 

We have summarized the relevant 

comments below, but have tried to 

present the commenters’ concerns and 

suggestions accurately and completely. 

Sections 13.00I and 113.00I—What do 

we mean by the following terms? 

We adopted a comment that suggested 

we include the term ‘‘multimodal’’ or 

the phrase ‘‘multimodal therapy’’ in the 

list of defined terms in sections 13.00I 

and 113.00I. The commenter also 

requested that we provide additional 

clarification of multimodal therapy. We 

adopted this comment by moving the 

definition of ‘‘multimodal therapy’’ 

from current sections 13.00E2 and 

113.00E2 to final sections 13.00I3 and 

113.00I2. We also revised the 

definitions in these sections to make 

them clearer. 

Since we added a new definition in 

final sections 13.00I and 113.00I, we 

renumbered the definitions that follow. 

We also changed the headings of these 

sections. In the NPRM, we used the 

heading ‘‘What do these terms in the 

listings mean?’’ for sections 13.00I and 

113.00I, and we included only terms 

that were actually included in the 

listings. We use the term ‘‘multimodal’’ 

in current listings 13.02 and 13.11, and 

final listing 13.14; however, we do not 

use it in any of the listings in part B. 

Since we do not use the terms 

‘‘multimodal’’ or ‘‘multimodal therapy’’ 

in any of the listings in part B, we 

changed the headings in both parts. 

We did not adopt a suggestion that we 

include in final section 13.00I a 

definition of the term ‘‘first treatment,’’ 

which is a term we use only when we 

refer to an autologous bone marrow 

transplant in current listing 13.28B. The 

commenter thought that we defined this 

term only in an internal instruction. In 

fact, we already define ‘‘first treatment’’ 

in current section 13.00L3b, where we 

explain how to use listing 13.28. 

Moreover, listing 13.28 refers to section 

13.00L3b. We think it will be easier for 

our adjudicators to find the definition if 

we leave it where it is. 

We also did not adopt a comment that 

recommended that we add a definition 

for ‘‘satellite lesions.’’ We use this term 

only in one section of the listing for 

melanoma (a kind of skin cancer), and 

we define it there. See final listing 

13.03B2c. 

Listing 13.02—Soft Tissue Tumors of 

the Head and Neck 

We did not adopt a comment 

recommending that we provide general 

guidance for evaluating bilateral 

neuroblastomas under current listing 

13.02A. We consider bilateral 

neuroblastomas to be tumors of the 

central nervous system, which we 

evaluate under listing 13.13. 

The same commenter suggested that 

we emphasize in the introductory text of 

the malignant neoplastic diseases body 

system how to evaluate soft tumors of 

the head and neck under current listing 

13.02A. We did not adopt this comment 

because the listing requires such tumors 

to be either ‘‘inoperable’’ or 

‘‘unresectable’’ and we already define 

those terms in final section 13.00I. 

We did, however, adopt a third 

comment from this commenter 

recommending that we explain how we 

evaluate a recurrence that occurs more 

than 3 years after remission in 

connection with listing 13.02 and 

another listing. In response to this 

comment, we revised the second 

sentence of current sections 13.00H2 

and 113.00H2, which referred only to 

the ‘‘original’’ tumor and any 

metastases, to also include recurrences 

and relapses. We also added a sentence 

at the end of final sections 13.00H3 and 

113.00H3 to indicate that, if there is a 

recurrence or relapse after 3 years or 

another period specified in a listing in 

this body system, the impairment may 

again meet or medically equal the 

requirements of a cancer listing. These 

changes are only a clarification of our 

current rules, and ensure that we will 

not incorrectly find that people with 

recurrent tumors are no longer disabled. 

Listing 13.03—Skin 

One commenter suggested that we 

include criteria in listing 13.03 for 

melanomas with ulcerative features. The 

commenter believed that the description 

of these melanomas in the current 

American Joint Committee on Cancer 

(AJCC) staging manual indicates listinglevel severity. We disagree with the 

commenter and have not adopted the 

comment. While the AJCC staging 

manual does indicate that melanomas 

with ulceration have a worse prognosis 

than non-ulcerated melanomas, it also 

indicates that many ulcerated 

melanomas have good prognoses. 

Therefore, we do not believe that the 

AJCC staging manual describes an 

impairment of listing-level severity, and 

it would be inappropriate for us to find 

that all people with this condition have 

a listing-level impairment. 

The same commenter recommended 

that we add criteria for melanoma with 

in-transit spread; that is, metastasis 

along the lymph channels. We did not 

adopt the comment because the final 

listings already address the disabling 

effects of in-transit spread. We will 

evaluate in-transit spread that affects the 

lymph nodes under final listing 

13.03B2a or 13.03B2b. We will evaluate 

in-transit spread that results in 

metastases to adjacent skin or distant 

sites under final listing 13.03B2c. 

Listing 13.09—Thyroid Gland 

In response to a comment, we added 

final listing 113.09C, for medullary 

carcinoma of the thyroid gland with 

metastases beyond the regional lymph 

nodes. Final listing 113.09C is identical 

to final listing 13.09C. The commenter 

referred to our statement in proposed 

113.00K4 that we did not include a 

specific listing for children because the 

condition is rare in children, but did not 

believe the listings are meant to exclude 

cancers simply because they are rare. 

Since our listings do include some rare 

disorders, we agreed to add this listing 

in response to the comment. We 

currently find all such children with the 

cancer described in final listing 113.09C 

disabled based on medical equivalence 

to listing 113.09B. 


CPrice-Sewell on DSKGBLS3C1PROD with RULES
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 51231 

4The capsule is a membrane of fibrous tissue that 

encases the lymph node. 

5See 73 FR at 22873. 

6See 69 FR at 67024. 

7For the list of references we consulted, see 73 

FR at 22875. 

8The Gleason grades and scores are used to help 

evaluate the prognosis of men with prostate cancer. 

In the NPRM, we explained in 

proposed section 113.00K4 that we 

would use listing 13.09C for children 

with this type of cancer. Because we are 

adding listing 113.09C, we did not 

include that paragraph in these final 

rules. 

Listing 13.10—Breast 

One commenter recommended that 

we include a listing for people with 

locally advanced breast cancer who 

receive multimodal therapy. The 

commenter recommended that we 

consider these people disabled for either 

12 or 18 months from the date of 

diagnosis. The commenter noted that we 

have other listings that recognize the 

difficulties faced by patients during 

initial treatment of their cancers, even 

though they have good prognoses, and 

believed that we could have a similar 

listing for some people with breast 

cancer. The commenter indicated that 

there are treatment regimens that last for 

at least 7 to 12 months that may have 

many side effects and that, as treatment 

progresses, the side effects worsen. 

We did not adopt this comment. 

While we agree with the commenter that 

there may be some people who are 

disabled from multimodal therapy for 

breast cancer and its adverse effects, we 

do not believe that we can uniformly 

describe those people medically, as 

required for a listing. Many people who 

undergo such therapy are not unable to 

work for 12 continuous months. 

Another commenter recommended 

that we add a criterion for metastatic 

breast cancer to an axillary lymph 

node(s) with perforation of the capsule 

(that is, tumor extension beyond the 

capsule),4 with or without nodal 

matting (fusion). We did not adopt this 

comment because, while perforation of 

the capsule, with or without matting, 

increases the risk of tumor recurrence, 

this finding alone does not usually 

represent the level of severity intended 

by the listings. We cannot have a listing 

based only on a risk of recurrence 

because people cannot qualify for 

disability benefits before they actually 

become unable to work (or for children 

under title XVI, meet the definition of 

disability for children). When there is 

recurrence, we will evaluate it under 

listing 13.10C. 

Listing 13.13—Nervous System 

One commenter recommended that 

we rewrite listing 13.13 to separate 

neoplasms that require metastases from 

those that do not. The commenter 

provided a suggested revision, but we 

did not adopt it for two reasons. First, 

the revisions we proposed to the listing 

did separate the neoplasms that require 

metastases from those that do not. As 

we explained in the preamble to the 

NPRM: 

We propose to make a minor editorial change 

to current listing 13.13A1 for highly 

malignant central nervous system neoplasms 

to clarify that the requirement for 

documented metastases applies only to 

medulloblastoma or other primitive 

neuroectodermal tumors (PNETs), and not to 

grades III and IV astrocytomas, glioblastoma 

multiforme, and ependymoblastoma. This is 

what we intend in the current rule, but we 

want[ ] to make the current sentence 

structure clearer. Therefore, we propose to 

reorganize the sentence for clarity.5

Second, and more importantly, the 

language the commenter proposed could 

have been misinterpreted to include 

under this listing medulloblastomas and 

other PNETs that have not metastasized. 

This interpretation would have been 

contrary to our intent, as we explained 

when we last made comprehensive 

revisions to the malignant neoplastic 

diseases body system in 2004.6 In that 

final rule, we explained that we could 

evaluate medulloblastomas or other 

PNETs that have not metastasized under 

listing 13.13A2. 

Listing 13.23—Cancers of the Female 

Genital Tract 

One commenter pointed out that we 

have no listing for cancer of the vagina, 

nor do we provide guidance in the 

introductory text on how adjudicators 

should evaluate this malignancy. The 

commenter suggested that we revise 

listing 13.23C to include cancer of the 

vagina or that we explain which listing 

to use to evaluate this condition. We 

adopted this comment by including 

cancer of the vagina in listing 13.23C. 

The criteria for listing-level cancer of 

the vulva are also appropriate for cancer 

of the vagina. Under the prior rules, we 

would have found medical equivalence 

to this listing in such cases. 

Two commenters expressed concern 

about our proposal to remove prior 

listing 13.23E1c, for ovarian cancer with 

ruptured ovarian capsule, tumor on the 

serosal surface, ascites with malignant 

cells, or positive peritoneal washings. 

One comment letter said that the 

medical literature with which the 

commenters were familiar showed that 

ovarian cancer with these findings has 

a high mortality rate. However, in the 

NPRM we cited current medical 

literature indicating that therapy has 

significantly improved the prognosis for 

women who have ovarian cancer with 

these findings.7 Based on this medical 

literature, we believe that most women 

who have ovarian cancer with the 

findings in prior listing 13.23E1c have 

a good prognosis. 

The other commenter, a national 

advocacy group for women with ovarian 

cancer, agreed with us that the 

prognosis for these cases has improved 

significantly, but recommended that we 

keep the listing to recognize the length 

and side effects of treatment. The 

commenter pointed out that women 

with these findings may undergo the 

same or similar surgery and 

chemotherapy as women with more 

advanced disease and that this 

treatment substantially limits those 

women’s ability for gainful activity. 

While we appreciate the second 

commenter’s concerns—and we agree 

that some women with the findings in 

the prior listing will be disabled—we 

did not adopt the recommendation to 

keep the listing, primarily because many 

women with the findings in prior listing 

13.23E1c will not be unable to work for 

at least 12 months. Even though they 

may be debilitated while they undergo 

treatment and for some time afterward, 

many of these women will have only 

minimal functional limitations 12 

months after diagnosis. Therefore, it 

would be inappropriate for us to keep 

the prior listing, which would require 

us to find that all women with the listed 

criteria are disabled. We must evaluate 

these cases on an individual basis. 

Finally, two commenters 

recommended that we not remove the 

listing 13.23E1c because there may be a 

recurrence of the disease, and a 

recurrence generally has a poor 

prognosis. We agree that recurrent 

ovarian cancer has a poor prognosis, but 

we already include it in final listing 

13.23E1c, our criterion for recurrent 

ovarian cancer. As we have already 

noted, we cannot have a listing based 

only on a risk of recurrence. 

Listing 13.24—Prostate Gland 

We did not adopt a suggestion that we 

clarify in the introductory text how our 

adjudicators should use the Gleason 

grading scale 8 in connection with 

listing 13.24 because the listing criteria 

are not based on this scale. The listing 

requires that the tumor not respond to 

initial hormonal treatment or that it 

metastasize to internal organs. The 


CPrice-Sewell on DSKGBLS3C1PROD with RULES
51232 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 

Gleason grade does not indicate whether 

the tumor meets these criteria. 

Other Changes From the NPRM 

We made a number of editorial 

corrections and changes in the final 

rules from the language of the NPRM. 

For example, we changed some 

sentences from passive into active voice. 

These changes are only for clarity, 

consistency, and to correct minor 

grammatical errors in the NPRM; none 

are substantive. 

What is our authority to make rules 

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. Sections 205(a), 

702(a)(5), and 1631(d)(1). 

Regulatory Procedures 

Executive Order 12866 

We have consulted with the Office of 

Management and Budget (OMB) and 

determined that these final rules meet 

the requirements for a significant 

regulatory action under Executive Order 

12866 and were subject to OMB review. 

Regulatory Flexibility Act 

We certify that these final rules have 

no significant economic impact on a 

substantial number of small entities 

because they affect only individuals. 

Therefore, a regulatory flexibility 

analysis was not required under the 

Regulatory Flexibility Act, as amended. 

Paperwork Reduction Act 

This rule does not create any new or 

affect any existing collections and, 

therefore, does not require Office of 

Management and Budget 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: July 30, 2009. 

Michael J. Astrue, 

Commissioner of Social Security. 

■ For the reasons set out in the 

preamble, we amend appendix 1 to 

subpart P of part 404 of chapter III of 

title 20 of the Code of Federal 

Regulations as set forth below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950– ) 

■ 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) and (i), 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) and (i), 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). 

■ 2. Amend appendix 1 to subpart P of 

Part 404 as follows: 

■ a. Revise item 14 of the introductory 

text before part A of appendix 1. 

■ b. Revise paragraph E2 of section 

13.00 of part A of appendix 1. 

■ c. Revise the second sentence of 

paragraph H2 and add a new second 

sentence to paragraph H3 of section 

13.00 of part A of appendix 1. 

■ d. Revise paragraph I of section 13.00 

of part A of appendix 1. 

■ e. Amend paragraph K of section 

13.00 of part A of appendix 1 by 

revising K1a, K1b, the third sentence of 

K2a, and K6. 

■ f. Revise listing 13.02C of part A of 

appendix 1. 

■ g. Revise listing 13.03B2 of part A of 

appendix 1. 

■ h. Amend listing 13.05 of part A of 

appendix 1 by revising the listing 

13.05A. 

■ i. Amend listing 13.09 of part A of 

appendix 1 by adding the word ‘‘OR’’ 

after listing 13.09B and adding listing 

13.09C. 

■ j. Revise listing 13.10B of part A of 

appendix 1. 

■ k. Revise the heading of listing 13.11 

of part A of appendix 1. 

■ l. Revise listing 13.13A of part A of 

appendix 1. 

■ m. Amend listing 13.14 of part A of 

appendix 1 by adding the word ‘‘OR’’ 

after listing 13.14B and adding listing 

13.14C. 

■ n. Revise listings 13.23C and 13.23E1 

of part A of appendix 1. 

■ o. Revise listing 13.24B of part A of 

appendix 1. 

■ p. Revise listing 13.27 of part A of 

appendix 1. 

■ q. Revise paragraph E2 of section 

113.00 of part B of appendix 1. 

■ r. Revise the second sentence of 

paragraph H2 and add a new second 

sentence to paragraph H3 of section 

113.00 of part B of appendix 1. 

■ s. Revise paragraph I of section 113.00 

of part B of appendix 1. 

■ t. Amend paragraph K of section 

113.00 of part B of appendix 1 by 

revising K1a, the third sentence of K2a, 

and K4. 

■ u. Amend listing 113.09 of part B of 

appendix 1 by adding the word ‘‘OR’’ 

after listing 113.09B and adding listing 

113.09C. 

■ v. Revise listing 113.13 of part B of 

appendix 1. 

The revised text is set forth as follows: 

Appendix 1 to Subpart P of Part 404— 

Listing of Impairments 

* * * * * 

14. Malignant Neoplastic Diseases (13.00 

and 113.00): November 5, 2017 

* * * * * 

Part A 

* * * * * 

13.00 MALIGNANT NEOPLASTIC 

DISEASES 

* * * * * 

E. When do we need longitudinal evidence? 

* * * * * 

2. Other malignancies. When there are no 

distant metastases, many of the listings 

require that we consider your response to 

initial antineoplastic 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 13.00I3). 

* * * * * 

H. How long do we consider your 

impairment to be disabling? 

* * * * * 

2. * * * 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. * * * If you have a recurrence or relapse 

of your malignancy, 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. Inoperable: 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 tumor 

that is too large or that has invaded crucial 

structures. This term does not include 

situations in which your tumor could have 

been surgically removed but another method 

of treatment was chosen; for example, an 

attempt at organ preservation. Your 

physician may determine whether a tumor is 

inoperable before or after you receive 

neoadjuvant therapy. Neoadjuvant therapy is 

antineoplastic therapy, such as 

chemotherapy or radiation, given before 

surgery in order to reduce the size of the 

tumor. 

2. Metastases: The spread of tumor cells by 

blood, lymph, or other body fluid. This term 

does not include the spread of tumor cells by 

direct extension of the tumor to other tissues 

or organs. 


CPrice-Sewell on DSKGBLS3C1PROD with RULES
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 51233 

3. Multimodal therapy: A combination of at 

least two types of treatment modalities 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, hormonal 

therapy, and immunotherapy). 

Examples of multimodal therapy include: 

a. Surgery followed by chemotherapy or 

radiation. 

b. Chemotherapy followed by surgery. 

c. Chemotherapy and concurrent radiation. 

4. Persistent: Failure to achieve a complete 

remission. 

5. Progressive: The malignancy becomes 

more extensive after treatment. 

6. Recurrent, relapse: A malignancy that 

was in complete remission or entirely 

removed by surgery has returned. 

7. Unresectable: Surgery was performed, 

but the malignant tumor was not removed. 

This term includes situations in which your 

tumor is incompletely resected or the 

surgical margins are positive. It does not 

include situations in which a tumor is 

completely resected but you are receiving 

adjuvant therapy. Adjuvant therapy is 

antineoplastic therapy, such as 

chemotherapy or radiation, given after 

surgery in order to eliminate any remaining 

cancer cells and lessen the chance of 

recurrence. 

* * * * * 

K. How do we evaluate specific malignant 

neoplastic diseases? 

1. Lymphoma. 

a. Many indolent (non-aggressive) 

lymphomas are controlled by well-tolerated 

treatment modalities, although the 

lymphomas may produce intermittent 

symptoms and signs. Therefore, 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.) When your disease has been 

stabilized, 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 

physician choose to change it, not because of 

a failure to achieve stability. 

* * * * * 

2. Leukemia. 

a. Acute leukemia. * * * Recurrent disease 

must be documented by peripheral blood, 

bone marrow, or cerebrospinal fluid 

examination, or by testicular biopsy. * * * 

* * * * * 

6. Brain tumors. We use the criteria in 

13.13 to evaluate malignant brain tumors. We 

consider a brain tumor to be malignant if it 

is classified as grade II or higher under the 

World Health Organization (WHO) 

classification of tumors of the central nervous 

system (WHO Classification of Tumours of 

the Central Nervous System, 2007). We 

evaluate any complications of malignant 

brain tumors, such as resultant neurological 

or psychological impairments, under the 

criteria for the affected body system. We 

evaluate benign brain tumors under 11.05. 

* * * * * 

13.02 Soft tissue tumors of the head and 

neck (except salivary glands—13.08—and 

thyroid gland—13.09). 

* * * * * 

C. Recurrent disease following initial 

antineoplastic therapy, except recurrence in 

the true vocal cord. 

* * * * * 

13.03 Skin. 

* * * * * 

B. Melanoma, as described in 1 or 2. 

* * * * * 

2. With metastases as described in a, b, or 

c: 

a. Metastases to one or more clinically 

apparent nodes; that is, nodes that are 

detected by imaging studies (excluding 

lymphoscintigraphy) or by clinical 

examination. 

b. If the nodes are not clinically apparent, 

with metastases to four or more nodes. 

c. Metastases to adjacent skin (satellite 

lesions) or distant sites. 

* * * * * 

13.05 Lymphoma (excluding T-cell 

lymphoblastic lymphoma—13.06). (See 

13.00K1 and 13.00K2c.) 

A. Non-Hodgkin’s lymphoma, as described 

in 1 or 2: 

1. Aggressive lymphoma (including diffuse 

large B-cell lymphoma) persistent or 

recurrent following initial antineoplastic 

therapy. 

2. Indolent lymphoma (including mycosis 

fungoides and follicular small cleaved cell) 

requiring initiation of more than one 

antineoplastic treatment regimen within a 

consecutive 12-month period. Consider 

under a disability from at least the date of 

initiation of the treatment regimen that failed 

within 12 months. 

* * * * * 

13.09 Thyroid gland. 

B. * * * 

OR 

C. Medullary carcinoma with metastases 

beyond the regional lymph nodes. 

13.10 Breast (except sarcoma—13.04). 

(See 13.00K4.) 

* * * * * 

B. Carcinoma with metastases to the 

supraclavicular or infraclavicular nodes, to 

10 or more axillary nodes, or with distant 

metastases. 

* * * * * 

13.11 Skeletal system—sarcoma. 

* * * * * 

13.13 Nervous system. (See 13.00K6.) 

A. Central nervous system malignant 

neoplasms (brain and spinal cord), as 

described in 1 or 2: 

1. Highly malignant tumors, such as 

medulloblastoma or other primitive 

neuroectodermal tumors (PNETs) with 

documented metastases, grades III and IV 

astrocytomas, glioblastoma multiforme, 

ependymoblastoma, diffuse intrinsic brain 

stem gliomas, or primary sarcomas. 

2. Progressive or recurrent following initial 

antineoplastic therapy. 

OR 

* * * * * 

13.14 Lungs. 

B. * * * 

OR 

C. Carcinoma of the superior sulcus 

(including Pancoast tumors) with multimodal 

antineoplastic therapy. Consider under a 

disability until at least 18 months from the 

date of diagnosis. Thereafter, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

* * * * * 

13.23 Cancers of the female genital 

tract—carcinoma or sarcoma. 

* * * * * 

C. Vulva or vagina, as described in 1, 2, or 

3: 

1. Invading adjoining organs. 

2. With metastases to or beyond the 

regional lymph nodes. 

3. Persistent or recurrent following initial 

antineoplastic therapy. 

* * * * * 

E. Ovaries, as described in 1 or 2: 

1. All tumors except germ cell tumors, with 

at least one of the following: 

a. Tumor extension beyond the pelvis; for 

example, tumor implants on peritoneal, 

omental, or bowel surfaces. 

b. Metastases to or beyond the regional 

lymph nodes. 

c. Recurrent following initial 

antineoplastic therapy. 

* * * * * 

13.24 Prostate gland—carcinoma. 

* * * * * 

B. With visceral metastases (metastases to 

internal organs). 

* * * * * 

13.27 Primary site unknown after 

appropriate search for primary—metastatic 

carcinoma or sarcoma, except for squamous 

cell carcinoma confined to the neck nodes. 

* * * * * 

Part B 

* * * * * 

113.00 MALIGNANT NEOPLASTIC 

DISEASES 

* * * * * 

E. When do we need longitudinal evidence? 

* * * * * 

2. Other malignancies. When there are no 

distant metastases, many of the listings 

require that we consider your response to 

initial antineoplastic 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 113.00I2). 

* * * * * 

H. How long do we consider your 

impairment to be disabling? 

* * * * * 

2. * * * 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) 


CPrice-Sewell on DSKGBLS3C1PROD with RULES
51234 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 

will no longer meet or medically equal the 

criteria of a listing in this body system. 

3. * * * If you have a recurrence or relapse 

of your malignancy, 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. Metastases: The spread of tumor cells by 

blood, lymph, or other body fluid. This term 

does not include the spread of tumor cells by 

direct extension of the tumor to other tissue 

or organs. 

2. Multimodal therapy: A combination of at 

least two types of treatment modalities 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, hormonal 

therapy, and immunotherapy). Examples of 

multimodal therapy include: 

a. Surgery followed by chemotherapy or 

radiation. 

b. Chemotherapy followed by surgery. 

c. Chemotherapy and concurrent radiation. 

3. Persistent: Failure to achieve a complete 

remission. 

4. Progressive: The malignancy becomes 

more extensive despite treatment. 

5. Recurrent, relapse: A malignancy that 

was in complete remission or entirely 

removed by surgery has returned. 

* * * * * 

K. How do we evaluate specific malignant 

neoplastic diseases? 

1. Lymphoma. 

a. We provide criteria for evaluating 

aggressive lymphomas that have not 

responded to antineoplastic therapy in 

113.05. Indolent (non-aggressive) lymphomas 

are rare in children. We will evaluate 

indolent lymphomas in children under 13.05 

in part A. 

* * * * * 

2. Leukemia. 

a. Acute leukemia. * * * Recurrent disease 

must be documented by peripheral blood, 

bone marrow, or cerebrospinal fluid 

examination, or by testicular biopsy. * * * 

* * * * * 

4. Brain tumors. We use the criteria in 

113.13 to evaluate malignant brain tumors. 

We consider a brain tumor to be malignant 

if it is classified as grade II or higher under 

the World Health Organization (WHO) 

classification of tumors of the central nervous 

system (WHO Classification of Tumours of 

the Central Nervous System, 2007). We 

evaluate any complications of malignant 

brain tumors, such as resultant neurological 

or psychological impairments, under the 

criteria for the affected body system. We 

evaluate benign brain tumors under 111.05. 

* * * * * 

113.09 Thyroid gland. 

B. * * * 

OR 

C. Medullary carcinoma with metastases 

beyond the regional lymph nodes. 

* * * * * 

113.13 Brain tumors. (See 113.00K4.) 

Highly malignant tumors, such as 

medulloblastoma or other primitive 

neuroectodermal tumors (PNETs) with 

documented metastases, grades III and IV 

astrocytomas, glioblastoma multiforme, 

ependymoblastoma, diffuse intrinsic brain 

stem gliomas, or primary sarcomas. 

* * * * * 

[FR Doc. E9–23896 Filed 10–5–09; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–327F] 

Schedules of Controlled Substances; 

Placement of Fospropofol Into 

Schedule IV 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Deputy Administrator of the 

Drug Enforcement Administration 

(DEA) places the substance fospropofol, 

including its salts, isomers and salts of 

isomers whenever the existence of such 

salts, isomers, and salts of isomers is 

possible, into schedule IV of the 

Controlled Substances Act (CSA). As a 

result of this rule, the regulatory 

controls and criminal sanctions of 

schedule IV will be applicable to the 

manufacture, distribution, dispensing, 

importation, and exportation of 

fospropofol and products containing 

fospropofol. 

DATES: Effective Date: November 5, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Office 

of Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, Virginia 22152, Telephone: 

(202) 307–7183. 

SUPPLEMENTARY INFORMATION: 

Background 

On December 12, 2008, the Food and 

Drug Administration (FDA) approved 

fospropofol for marketing under the 

trade name Lusedra® in the United 

States as a drug product indicated for 

monitored anesthesia care (MAC) 

sedation in adult patients undergoing 

diagnostic or therapeutic procedures. 

Fospropofol, 2,6- 

diisopropopylphenoxymethyl 

phosphate disodium, is a water soluble, 

phosphono-O-methyl prodrug of 

propofol. It is metabolized in the body 

to propofol, the active metabolite. 

Propofol has been available for medical 

use in the United States since 1989 and 

is not currently a controlled substance. 

The pharmacological effects of 

fospropofol are attributed to the 

pharmacological actions of propofol. 

Propofol binds to g-aminobutyric acid 

(GABAA) receptor and acts as a 

modulator by potentiating the activity of 

GABA at this receptor. 

Since propofol is the active metabolite 

of fospropofol, the abuse potential of 

fospropofol is comparable to that of 

propofol. Animal self-administration 

studies demonstrated that the 

reinforcing effects of propofol are 

relatively low and comparable to 

midazolam and other schedule IV 

benzodiazepines. Fospropofol elicits 

behavioral effects similar to 

methohexital and midazolam, schedule 

IV sedative-hypnotics. 

Since fospropofol is a new molecular 

entity, there has been no evidence of 

diversion, abuse, or law enforcement 

encounters involving the drug. 

On February 27, 2009, the Acting 

Assistant Secretary for Health, 

Department of Health and Human 

Services (DHHS), sent the Deputy 

Administrator of DEA a scientific and 

medical evaluation and a letter 

recommending that fospropofol be 

placed into schedule IV of the CSA. 

Enclosed with the February 27, 2009, 

letter was a document prepared by the 

FDA entitled, ‘‘Basis for the 

Recommendation for Control of 

Fospropofol and Its Salts in Schedule IV 

of the Controlled Substances Act 

(CSA).’’ The document contained a 

review of the factors which the CSA 

requires the Secretary to consider 

(21 U.S.C. 811(b)). 

After a review of the available data, 

including the scientific and medical 

evaluation and the scheduling 

recommendation from DHHS, the 

Deputy Administrator of the DEA 

published a Notice of Proposed 

Rulemaking entitled ‘‘Schedules of 

Controlled Substances: Placement of 

Fospropofol into Schedule IV’’ on July 

23, 2009 (74 FR 36424), which proposed 

placement of fospropofol into schedule 

IV of the CSA. The proposed rule 

provided an opportunity for all 

interested persons to submit their 

written comments on or before August 

24, 2009. 

Comments Received 

The DEA received two comments in 

response to the Notice of Proposed 

Rulemaking. One comment received 

from a concerned citizen did not relate 

to fospropofol, the substance that is 

being controlled. Thus DEA did not 

consider this comment. 


CPrice-Sewell on DSKGBLS3C1PROD with RULES