Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Rules and Regulations 61221 

We do not have information at this 

point on the quantity of bananas that the 

Philippines expects to ship to the State 

of Hawaii or to the U.S. territories, or 

the quantity and origin of bananas 

already imported into these 

destinations. However, Hawaii as well 

as the U.S. territories, already import 

bananas from other places since the 

volume of banana consumption is 

greater than their production. In general, 

the quantity of U.S. imports from the 

Philippines is expected to be relatively 

insignificant, equivalent to about 0.05 

percent of U.S. imports from other 

countries. What percent would go to 

Hawaii depends on the demand from 

the consumers in the State of Hawaii 

and in the other U.S. territories. 

Consumers in Hawaii and the U.S. 

territories would benefit from the 

additional source of fresh bananas, 

which are of similar quality as the 

domestic ones. 

Executive Order 12988 

This final rule allows bananas to be 

imported into Guam, Hawaii, and the 

Northern Mariana Islands from the 

Philippines. State and local laws and 

regulations regarding bananas imported 

under this rule will be preempted while 

the fruit is in foreign commerce. Fresh 

fruits are generally imported for 

immediate distribution and sale to the 

consuming public, and remain in 

foreign commerce until sold to the 

ultimate consumer. The question of 

when foreign commerce ceases in other 

cases must be addressed on a case-bycase basis. No retroactive effect will be 

given to this rule, and this rule will not 

require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

National Environmental Policy Act 

An environmental assessment (EA) 

and finding of no significant impact 

were prepared in 2012 for a final rule 

for importation of bananas from the 

Philippines into the continental United 

States. The EA provided a basis for the 

conclusion that the importation of 

bananas from the Philippines into the 

continental United States, under the 

conditions specified in that rule, would 

not have a significant impact on the 

quality of the human environment. 

APHIS reviewed the proposal to import 

bananas from the Philippines into 

Guam, Hawaii, and the Northern 

Mariana Islands under the conditions 

specified in this rule, and determined 

that this will not have a significant 

impact on the quality of the human 

environment. APHIS prepared an 

amended finding of no significant 

impact, and the Administrator of the 

Animal and Plant Health Inspection 

Service has determined that an 

environmental impact statement need 

not be prepared. 

The 2012 EA and amended finding of 

no significant impact were prepared in 

accordance with: (1) The National 

Environmental Policy Act of 1969 

(NEPA), as amended (42 U.S.C. 4321 et 

seq.); (2) regulations of the Council on 

Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508); (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b); and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

The EA and amended finding of no 

significant impact may be viewed on the 

Regulations.gov Web site (see footnote 

1). Copies of the EA and amended 

finding of no significant impact are also 

available for public inspection at USDA, 

room 1141, South Building, 14th Street 

and Independence Avenue SW., 

Washington, DC, between 8 a.m. and 

4:30 p.m., Monday through Friday, 

except holidays. Persons wishing to 

inspect copies are requested to call 

ahead on (202) 799–7039 to facilitate 

entry into the reading room. In addition, 

copies may be obtained by writing to the 

individual listed under FOR FURTHER

INFORMATION CONTACT. 

Paperwork Reduction Act 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection or recordkeeping 

requirements included in this final rule, 

which were filed under 0579–0415, 

have been submitted for approval to the 

Office of Management and Budget 

(OMB). When OMB notifies us of its 

decision, if approval is denied, we will 

publish a document in the Federal 

Register providing notice of what action 

we plan to take. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this rule, please contact Ms. Kimberly 

Hardy, APHIS’ Information Collection 

Coordinator, at (301) 851–2727. 

List of Subjects in 7 CFR Part 319 

Coffee, Cotton, Fruits, Imports, Logs, 

Nursery stock, Plant diseases and pests, 

Quarantine, Reporting and 

recordkeeping requirements, Rice, 

Vegetables. 

Accordingly, we are amending 7 CFR 

part 319 as follows: 

PART 319—FOREIGN QUARANTINE 

NOTICES 

■ 1. The authority citation for part 319 

continues to read as follows: 

Authority: 7 U.S.C. 450, 7701–7772, and 

7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 

2.22, 2.80, and 371.3. 

■ 2. Section 319.56–58 is amended as 

follows: 

■ a. The introductory text is revised; 

■ b. In paragraph (c), the date ‘‘February 

9, 2015’’ is removed and the date 

‘‘November 10, 2016’’ is added in its 

place; 

■ c. In paragraph (h)(2), in the second 

sentence, the words ‘‘introductory text 

of this section’’ are removed and the 

words ‘‘operational workplan required 

by paragraph (a)(1) of this section’’ are 

added in their place; and 

■ d. In the OMB citation at the end of 

the section, the words ‘‘number 0579– 

0394’’ are removed and the words 

‘‘numbers 0579–0394 and 0579–0415’’ 

are added in their place. 

The revision reads as follows: 

§ 319.56–58 Bananas from the Philippines. 

Bananas (Musa spp., which include 

M. acuminate cultivars and M. 

acuminate x M. balbisiana hybrids) may 

be imported into the continental United 

States, Guam, Hawaii, and the Northern 

Mariana Islands from the Philippines 

only under the conditions described in 

this section. 

* * * * * 

Done in Washington, DC, this 6th day of 

October 2014. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2014–24246 Filed 10–9–14; 8:45 am] 

BILLING CODE 3410–34–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 404 

[Docket No. SSA–2009–0038] 

RIN 0960–AH03 

Revised Medical Criteria for Evaluating 

Genitourinary Disorders 

AGENCY: Social Security Administration. 

ACTION: Final rules. 

SUMMARY: These final rules revise the 

criteria in the Listing of Impairments 

(listings) that we use to evaluate cases 

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61222 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Rules and Regulations 

1 20 CFR 404.1509 and 416.909. 

2See 42 U.S.C. 423(d)(1)(a) and (d)(2)(a), and 

1382c(a)(3)(A) and 20 CFR 404.1505, 404.1509, 

416.905, 416.906, and 416.909. 

3See 20 CFR 416.926 and 416.926a(a). 

involving genitourinary disorders in 

adults and children under titles II and 

XVI of the Social Security Act (Act). The 

revisions reflect our program experience 

and address adjudicator questions we 

have received since we last 

comprehensively revised this body 

system in 2005. 

DATES: These rules are effective 

December 9, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Cheryl A. Williams, Office of Medical 

Policy, Social Security Administration, 

6401 Security Boulevard, Baltimore, 

Maryland 21235–6401, (410) 965–1020. 

For information on eligibility or filing 

for benefits, call our national toll-free 

number, 1–800–772–1213, or TTY 

1–800–325–0778, or visit our Internet 

site, Social Security Online, at http://

www.socialsecurity.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

We are making final the rules for 

evaluating genitourinary disorders that 

we proposed in a notice of proposed 

rulemaking (NPRM) we published in the 

Federal Register on February 4, 2013 at 

78 FR 7695. The preamble to the NPRM 

provides the background for these 

revisions. You can view the preamble to 

the NPRM by visiting http://

www.regulations.gov and searching for 

document ‘‘SSA–2009–0038–0005.’’ We 

are making a number of changes in 

response to public comments to the 

NPRM, which we explain below. 

Why are we revising the listings for 

evaluating genitourinary disorders? 

We are revising the listings for 

evaluating genitourinary disorders to 

update the medical criteria, clarify how 

we evaluate genitourinary disorders, 

and address adjudicator questions. 

Public Comments 

In the NPRM, we provided the public 

with a 60-day comment period, which 

ended on April 5, 2013. We received six 

comments. The comments came from 

members of the public, disability 

adjudicators, and a national association 

representing disability examiners in the 

State agencies that make disability 

determinations for us. 

We carefully considered all of the 

comments. We have tried to summarize 

the commenters’ views accurately and 

respond to all of the significant issues 

raised by the commenters that were 

within the scope of these rules. Some 

commenters noted provisions with 

which they agreed and did not make 

suggestions for changes in those 

provisions. We did not summarize or 

respond to those comments. 

Comment: One commenter asked if 

we would require the estimated 

glomerular filtration rate (eGFR) to be 

adjusted for race and sex. The 

commenter also suggested that we 

establish an eGFR calculator to calculate 

the eGFR for the criterion in proposed 

6.05A. 

Response: We did not adopt this 

comment. The eGFR is a calculated 

value based on the measured serum 

creatinine. The formulas used by 

laboratories to calculate eGFR all 

include adjustments for age, race, and 

sex. We will use the eGFR value as 

calculated by the laboratory and will not 

independently calculate eGFR. Thus, we 

will not develop a calculator for eGFR. 

Comment: Another commenter noted 

that the weight loss criterion in 

proposed listing 6.05B4 (body mass 

index (BMI) of 18.0 or less) is not 

consistent with the weight loss criterion 

in listing 5.08 (BMI of less than 17.5) 

and suggested that we change the 

criterion for consistency. 

Response: We did not adopt this 

comment. We believe it is appropriate to 

use a different BMI criterion for listing 

6.05B4 than we use in listing 5.08. The 

criterion in listing 6.05B4 considers the 

severity of a person’s underlying 

chronic kidney disease (CKD) and its 

effect on his or her nutrition and 

metabolic status. People with CKD are 

unable to maintain adequate weight due 

to decreased dietary protein intake and 

decreased dietary energy intake, which 

are hallmarks of kidney failure. People 

with CKD may have an increased 

prevalence of protein energy 

malnutrition. Furthermore, listing 5.08 

requires a lower BMI because the listing 

considers only weight loss due to any 

digestive disorder. Listing 5.08 does not 

consider the severity of the individual’s 

underlying digestive disorder. 

In listing 5.08, we require BMI of less 

than 17.5 calculated on at least two 

evaluations, at least 60 days apart, 

within a consecutive 6-month period. In 

final listing 6.05B4, we require the same 

number of BMI evaluations within a 

consecutive 12-month period. We are 

using the consecutive 12-month period 

to be consistent with the 12-month 

duration requirement.1 The 12-month 

period is also consistent with the period 

we use when we evaluate 

hospitalizations due complications of a 

genitourinary disorder in 6.09 and 

106.09. 

Comment: One commenter expressed 

concern about proposed listing 6.09, 

regarding how to explain ‘‘CKD 

complications requiring hospitalizations 

versus hospitalizations due to a group of 

co-morbid conditions, including CKD.’’ 

The same commenter also suggested 

that we add guidance in the 

introductory text to address acute 

worsening of CKD during 

hospitalizations for co-occurring 

conditions. 

Response: We agree with the 

comment and provided clarification 

regarding CKD complications in final 

listings 6.00C8 and 106.00C5. 

Comment: A commenter suggested 

revisions to proposed listing 106.07 

requesting a 24-month period with 3 

surgeries for childhood genitourinary 

disorders instead of 3 surgeries within 

12-month period. 

Response: We are not adopting this 

comment because using a 12-month 

period for evaluating an impairment is 

an intrinsic part of our basic definition 

of disability.2 We consider the 

combinations of impairments and 

limitations in functioning at step 3 of 

the sequential evaluation process, using 

our medical equivalence and functional 

equivalence rules.3 We recognize that 

some children who have multiple 

surgeries for genitourinary impairments 

may have limitations in functioning that 

last longer. In such cases, we evaluate 

those limitations under our medical 

equivalence and functional equivalence 

rules. 

Comment: One commenter stated that 

there are undefined and poorly defined 

terms in the genitourinary listings. The 

commenter said these terms included 

‘‘frequent,’’ ‘‘intractable,’’ ‘‘interferes,’’ 

‘‘anasarca,’’ ‘‘anorexia,’’ and ‘‘severe 

bone pain.’’ 

Response: We partially adopted this 

comment. We provide brief definitions 

for several medical terms when we first 

use the terms in the introductory text of 

these final listings. We define anasarca 

in 6.00C6 and 106.00C3; anorexia in 

6.00C7; and ‘‘severe bone pain’’ and 

‘‘intractable’’ in 6.00C3. We have not 

provided definitions for the terms 

‘‘frequent’’ and ‘‘interferes.’’ We use 

these two terms in our definition of 

‘‘severe bone pain’’ and use them in 

their common English usage. 

Comment: A commenter stated that 

there are no listings for combinations of 

impairments. The commenter stated that 

the NPRM includes only single 

genitourinary disorders and leaves out 

many important combinations of 

disorders. Examples that the commenter 

provided included severe CKD not 

requiring dialysis and coronary artery 

disease; peripheral neuropathy and 

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Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Rules and Regulations 61223 

4See 20 CFR 404.1526 and 416.926. 5See 20 CFR 404.1519m and 416.919m. 6 42 U.S.C. 405(a), 902(a)(5), and 1383(d)(1). 

generalized edema; and fluid overload 

and coronary artery disease. The 

commenter also noted ‘‘a complete lack 

of listings that consider obesity.’’ 

Response: We did not adopt this 

comment. We recognize that 

genitourinary disorders may co-occur 

with impairments in other body 

systems. In some cases, the impairment 

in another body system results from a 

genitourinary disorder; for example, 

peripheral neuropathy resulting from 

CKD. In other cases, the impairment in 

another body system is not related to the 

genitourinary disorder; for example, 

peripheral neuropathy resulting from 

diabetes mellitus. 

We intend the listings to address 

genitourinary disorders and the 

complications of those disorders. When 

the co-occurring condition or 

complication is due to a genitourinary 

disorder, we evaluate it under final 

listing 6.09. However, when the cooccurring impairments are unrelated, 

we believe it is more appropriate to 

evaluate the combination under our 

medical equivalence rule at step 3 of the 

sequential evaluation process, or at 

steps 4 and 5 of the sequential 

evaluation process.4 At these steps, 

adjudicators can account for specific 

combinations of impairments, 

complications of those impairments, 

and limitations of functioning on an 

individual case basis. We address this in 

the introductory text of final listing 

6.00C8. 

Comment: A commenter noted that 

we provide no quantitative data to show 

the validity of any of our genitourinary 

proposed listings and noted that many 

people engage in substantial gainful 

activity (SGA) even though they meet 

the requirements of a listing. The 

commenter believes that this challenges 

the validity of using the listings to 

determine whether a person is disabled. 

Response: We disagree with this 

comment. Our NPRM included an 

extensive list of medical and other 

references that we relied on in 

proposing these rules. We also invited 

the public to comment on these 

references and the data contained 

within them. 

The listings help to ensure that 

determinations or decisions of disability 

have a sound medical basis, that 

claimants receive equal treatment 

throughout the country, and that we can 

readily identify the majority of persons 

who are disabled. The level of severity 

described in the listings is such that an 

individual, whom is not engaging in 

SGA and has an impairment that meets 

or medically equals all of the criteria of 

the listing, is generally considered 

unable to work because of the medical 

impairment alone at step three of the 

sequential evaluation process. Thus, 

when such a person’s impairment or 

combination of impairments meets or 

medically equals the level of severity 

described in the listing for the required 

duration, disability will be found on the 

basis of the medical facts alone in the 

absence of evidence to the contrary, for 

example, the actual performance of 

SGA. 

Comment: A commenter stated that 

the proposed criteria discriminate 

against the poor because they include 

medical tests that people cannot afford 

and that we will not purchase, such as 

kidney or bone biopsies, imaging 

studies, and 24-hour urine protein tests. 

The same commenter also stated that 

requirements, such as 90 consecutive 

days of prescribed therapy, urologic 

surgical procedures, and 

hospitalization, discriminate against 

people who cannot afford treatment, 

and suggested that we delete the 

requirements ‘‘[u]nless the 

Administration is willing to make a 

commitment to purchase these.’’ 

Response: We did not adopt the 

commenter’s suggestion. People with 

the very serious genitourinary 

impairments described in these listings 

generally receive the kinds of diagnostic 

tests and treatments described in these 

final rules because of urgent medical 

need. However, we do not penalize 

people who do not have the kinds of 

medical evidence that we describe in 

these listings. Under our rules, we may 

purchase medical examinations or tests 

to obtain the evidence that we need, but 

we will not purchase diagnostic tests 

that involve significant risk to the 

person, such as kidney or bone 

biopsies.5 Furthermore, we provide 

several alternatives for people with 

genitourinary impairments to establish 

that their impairment is of listing-level 

severity at step three of the sequential 

evaluation process. If the impairment is 

not of listing-level severity, we may find 

the person disabled at subsequent steps 

of the sequential evaluation process 

when considering the person’s residual 

functional capacity, age, education, and 

work experience. 

Comment: Two commenters pointed 

out stylistic and technical editorial 

issues in the preamble and the proposed 

rules. 

Response: We have made appropriate 

corrections in these final rules. 

Other Changes 

In addition to the changes we made in 

response to public comments, we 

revised 6.00C1 and 106.00C1 to clarify 

the documentation requirement for 

hemodialysis or peritoneal dialysis. 

What is our authority to make rules 

and set procedures for determining 

whether a person is disabled under the 

statutory definition? 

The Act authorizes us to make rules 

and regulations and to establish 

necessary and appropriate procedures to 

implement them.6

How long will these final rules be 

effective? 

These final rules will remain in effect 

for 5 years after the date they become 

effective, unless we extend them, or 

revise and issue them again. 

Regulatory Procedures 

Executive Order 12866, as 

Supplemented by Executive Order 

13563 

We consulted with the Office of 

Management and Budget (OMB) and 

determined that these final rules meet 

the criteria for a significant regulatory 

action under Executive Order 12866, as 

supplemented by Executive Order 

13563 and was reviewed by OMB. 

Regulatory Flexibility Act 

We certify that these final rules will 

not have a significant economic impact 

on a substantial number of small entities 

because they affect individuals only. 

Therefore, the Regulatory Flexibility 

Act, as amended, does not require us to 

prepare a regulatory flexibility analysis. 

Paperwork Reduction Act 

These final rules do not create any 

new or affect any existing collections 

and, therefore, do not require OMB 

approval under the Paperwork 

Reduction Act. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social Security— 

Disability Insurance; 96.002, Social 

Security—Retirement Insurance; 96.004, 

Social Security—Survivors Insurance; and 

96.006, Supplemental Security Income) 

List of Subjects in 20 CFR Part 404 

Administrative practice and 

procedure, Blind, Disability benefits, 

Old-Age, survivors, and disability 

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61224 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Rules and Regulations 

insurance, Reporting and recordkeeping 

requirements, Social Security. 

Carolyn W. Colvin, 

Acting Commissioner of Social Security. 

For the reasons set out in the 

preamble, we are amending 20 CFR part 

404, subpart P as set forth below: 

PART 404—FEDERAL OLD–AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950–) 

Subpart P—Determining Disability and 

Blindness 

■ 1. The authority citation for subpart P 

of part 404 continues to read as follows: 

Authority: Secs. 202, 205(a)–(b) and (d)– 

(h), 216(i), 221(a), (i), and (j), 222(c), 223, 

225, and 702(a)(5) of the Social Security Act 

(42 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i), 

421(a), (i), and (j), 422(c), 423, 425, and 

902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 

Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 

118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. Amend appendix 1 to subpart P of 

part 404 by: 

■ a. Revising item 7 of the introductory 

text before part A; 

■ b. In part A: 

■ i. Revising the body system name for 

section 6.00 in the table of contents; and 

■ ii. Revising section 6.00; 

■ c. In part B: 

■ i. Revising the body system name for 

section 106.00 in the table of contents; 

and 

■ ii. Revising section 106.00. 

The revisions read as follows: 

Appendix 1 to Subpart P of Part 404— 

Listing of Impairments 

* * * * * 

7. Genitourinary Disorders (6.00 and 

106.00): December 9, 2019. 

* * * * * 

Part A 

* * * * * 

6.00 Genitourinary Disorders. 

* * * * * 

6.00 GENITOURINARY DISORDERS 

A. Which disorders do we evaluate under 

these listings? 

We evaluate genitourinary disorders 

resulting in chronic kidney disease (CKD). 

Examples of such disorders include chronic 

glomerulonephritis, hypertensive 

nephropathy, diabetic nephropathy, chronic 

obstructive uropathy, and hereditary 

nephropathies. We also evaluate nephrotic 

syndrome due to glomerular dysfunction 

under these listings. 

B. What evidence do we need? 

1. We need evidence that documents the 

signs, symptoms, and laboratory findings of 

your CKD. This evidence should include 

reports of clinical examinations, treatment 

records, and documentation of your response 

to treatment. Laboratory findings, such as 

serum creatinine or serum albumin levels, 

may document your kidney function. We 

generally need evidence covering a period of 

at least 90 days unless we can make a fully 

favorable determination or decision without 

it. 

2. Estimated glomerular filtration rate 

(eGFR). The eGFR is an estimate of the 

filtering capacity of the kidneys that takes 

into account serum creatinine concentration 

and other variables, such as your age, gender, 

and body size. If your medical evidence 

includes eGFR findings, we will consider 

them when we evaluate your CKD under 

6.05. 

3. Kidney or bone biopsy. If you have had 

a kidney or bone biopsy, we need a copy of 

the pathology report. When we cannot get a 

copy of the pathology report, we will accept 

a statement from an acceptable medical 

source verifying that a biopsy was performed 

and describing the results. 

C. What other factors do we consider when 

we evaluate your genitourinary disorder? 

1. Chronic hemodialysis or peritoneal 

dialysis. 

a. Dialysis is a treatment for CKD that uses 

artificial means to remove toxic metabolic 

byproducts from the blood. Hemodialysis 

uses an artificial kidney machine to clean 

waste products from the blood; peritoneal 

dialysis uses a dialyzing solution that is 

introduced into and removed from the 

abdomen (peritoneal cavity) either 

continuously or intermittently. Under 6.03, 

your ongoing dialysis must have lasted or be 

expected to last for a continuous period of at 

least 12 months. To satisfy the requirements 

in 6.03, we will accept a report from an 

acceptable medical source that describes 

your CKD and your current dialysis, and 

indicates that your dialysis will be ongoing. 

b. If you are undergoing chronic 

hemodialysis or peritoneal dialysis, your 

CKD may meet our definition of disability 

before you started dialysis. We will 

determine the onset of your disability based 

on the facts in your case record. 

2. Kidney transplant. 

a. If you receive a kidney transplant, we 

will consider you to be disabled under 6.04 

for 1 year from the date of transplant. After 

that, we will evaluate your residual 

impairment(s) by considering your posttransplant function, any rejection episodes 

you have had, complications in other body 

systems, and any adverse effects related to 

ongoing treatment. 

b. If you received a kidney transplant, your 

CKD may meet our definition of disability 

before you received the transplant. We will 

determine the onset of your disability based 

on the facts in your case record. 

3. Renal osteodystrophy. This condition is 

the bone degeneration resulting from chronic 

kidney disease-mineral and bone disorder 

(CKD–MBD). CKD–MBD occurs when the 

kidneys are unable to maintain the necessary 

levels of minerals, hormones, and vitamins 

required for bone structure and function. 

Under 6.05B1, ‘‘severe bone pain’’ means 

frequent or intractable (resistant to treatment) 

bone pain that interferes with physical 

activity or mental functioning. 

4. Peripheral neuropathy. This disorder 

results when the kidneys do not adequately 

filter toxic substances from the blood. These 

toxins can adversely affect nerve tissue. The 

resulting neuropathy may affect peripheral 

motor or sensory nerves, or both, causing 

pain, numbness, tingling, and muscle 

weakness in various parts of the body. Under 

6.05B2, the peripheral neuropathy must be a 

severe impairment. (See §§ 404.1520(c), 

404.1521, 416.920(c), and 416.921 of this 

chapter.) It must also have lasted or be 

expected to last for a continuous period of at 

least 12 months. 

5. Fluid overload syndrome. This condition 

occurs when excess sodium and water 

retention in the body due to CKD results in 

vascular congestion. Under 6.05B3, we need 

a description of a physical examination that 

documents signs and symptoms of vascular 

congestion, such as congestive heart failure, 

pleural effusion (excess fluid in the chest), 

ascites (excess fluid in the abdomen), 

hypertension, fatigue, shortness of breath, or 

peripheral edema. 

6. Anasarca (generalized massive edema or 

swelling). Under 6.05B3 and 6.06B, we need 

a description of the extent of edema, 

including pretibial (in front of the tibia), 

periorbital (around the eyes), or presacral (in 

front of the sacrum) edema. We also need a 

description of any ascites, pleural effusion, or 

pericardial effusion. 

7. Anorexia (diminished appetite) with 

weight loss. Anorexia is a frequent sign of 

CKD and can result in weight loss. We will 

use body mass index (BMI) to determine the 

severity of your weight loss under 6.05B4. 

(BMI is the ratio of your measured weight to 

the square of your measured height.) The 

formula for calculating BMI is in section 

5.00G. 

8. Complications of CKD. The 

hospitalizations in 6.09 may be for different 

complications of CKD. Examples of 

complications from CKD that may result in 

hospitalization include stroke, congestive 

heart failure, hypertensive crisis, or acute 

kidney failure requiring a short course of 

hemodialysis. If the CKD complication 

occurs during a hospitalization that was 

initially for a co-occurring condition, we will 

evaluate it under our rules for determining 

medical equivalence. (See §§ 404.1526 and 

416.926 of this chapter.) We will evaluate cooccurring conditions, including those that 

result in hospitalizations, under the listings 

for the affected body system or under our 

rules for medical equivalence. 

D. How do we evaluate disorders that do not 

meet one of the genitourinary listings? 

1. The listed disorders are only examples 

of common genitourinary disorders that we 

consider severe enough to prevent you from 

doing any gainful activity. If your 

impairment(s) does not meet the criteria of 

any of these listings, we must also consider 

whether you have an impairment(s) that 

satisfies the criteria of a listing in another 

body system. 

2. If you have a severe medically 

determinable impairment(s) that does not 

meet a listing, we will determine whether 

your impairment(s) medically equals a 

listing. (See §§ 404.1526 and 416.926 of this 

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Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Rules and Regulations 61225 

chapter.) Genitourinary disorders may be 

associated with disorders in other body 

systems, and we consider the combined 

effects of multiple impairments when we 

determine whether they medically equal a 

listing. If your impairment(s) does not meet 

or medically equal the criteria of a listing, 

you may or may not have the residual 

functional capacity to engage in substantial 

gainful activity. We proceed to the fourth 

and, if necessary, the fifth steps of the 

sequential evaluation process in §§ 404.1520 

and 416.920 of this chapter. We use the rules 

in §§ 404.1594 and 416.994 of this chapter, 

as appropriate, when we decide whether you 

continue to be disabled. 

6.01 Category of Impairments, 

Genitourinary Disorders 

6.03 Chronic kidney disease, with 

chronic hemodialysis or peritoneal dialysis 

(see 6.00C1). 

6.04 Chronic kidney disease, with kidney 

transplant. Consider under a disability for 1 

year following the transplant; thereafter, 

evaluate the residual impairment (see 

6.00C2). 

6.05 Chronic kidney disease, with 

impairment of kidney function, with A and 

B: 

A. Reduced glomerular filtration evidenced 

by one of the following laboratory findings 

documented on at least two occasions at least 

90 days apart during a consecutive 12-month 

period: 

1. Serum creatinine of 4 mg/dL or greater; 

or 

2. Creatinine clearance of 20 ml/min. or 

less; or 

3. Estimated glomerular filtration rate 

(eGFR) of 20 ml/min/1.73m2 or less. 

AND 

B. One of the following: 

1. Renal osteodystrophy (see 6.00C3) with 

severe bone pain and imaging studies 

documenting bone abnormalities, such as 

osteitis fibrosa, osteomalacia, or pathologic 

fractures; or 

2. Peripheral neuropathy (see 6.00C4); or 

3. Fluid overload syndrome (see 6.00C5) 

documented by one of the following: 

a. Diastolic hypertension greater than or 

equal to diastolic blood pressure of 110 mm 

Hg despite at least 90 consecutive days of 

prescribed therapy, documented by at least 

two measurements of diastolic blood 

pressure at least 90 days apart during a 

consecutive 12-month period; or 

b. Signs of vascular congestion or anasarca 

(see 6.00C6) despite at least 90 consecutive 

days of prescribed therapy, documented on at 

least two occasions at least 90 days apart 

during a consecutive 12-month period; or 

4. Anorexia with weight loss (see 6.00C7) 

determined by body mass index (BMI) of 18.0 

or less, calculated on at least two occasions 

at least 90 days apart during a consecutive 

12-month period. 

6.06 Nephrotic syndrome, with A and B: 

A. Laboratory findings as described in 1 or 

2, documented on at least two occasions at 

least 90 days apart during a consecutive 12- 

month period: 

1. Proteinuria of 10.0 g or greater per 24 

hours; or 

2. Serum albumin of 3.0 g/dL or less, and 

a. Proteinuria of 3.5 g or greater per 24 

hours; or 

b. Urine total-protein-to-creatinine ratio of 

3.5 or greater. 

AND 

B. Anasarca (see 6.00C6) persisting for at 

least 90 days despite prescribed treatment. 

6.09 Complications of chronic kidney 

disease (see 6.00C8) requiring at least three 

hospitalizations within a consecutive 12- 

month period and occurring at least 30 days 

apart. Each hospitalization must last at least 

48 hours, including hours in a hospital 

emergency department immediately before 

the hospitalization. 

* * * * * 

Part B 

* * * * * 

106.00 Genitourinary Disorders. 

* * * * * 

106.00 GENITOURINARY DISORDERS 

A. Which disorders do we evaluate under 

these listings? 

We evaluate genitourinary disorders 

resulting in chronic kidney disease (CKD). 

Examples of such disorders include chronic 

glomerulonephritis, hypertensive 

nephropathy, diabetic nephropathy, chronic 

obstructive uropathy, and hereditary 

nephropathies. We also evaluate nephrotic 

syndrome due to glomerular dysfunction, 

and congenital genitourinary disorders, such 

as ectopic ureter, exotrophic urinary bladder, 

urethral valves, and Eagle-Barrett syndrome 

(prune belly syndrome), under these listings. 

B. What evidence do we need? 

1. We need evidence that documents the 

signs, symptoms, and laboratory findings of 

your CKD. This evidence should include 

reports of clinical examinations, treatment 

records, and documentation of your response 

to treatment. Laboratory findings, such as 

serum creatinine or serum albumin levels, 

may document your kidney function. We 

generally need evidence covering a period of 

at least 90 days unless we can make a fully 

favorable determination or decision without 

it. 

2. Estimated glomerular filtration rate 

(eGFR). The eGFR is an estimate of the 

filtering capacity of the kidneys that takes 

into account serum creatinine concentration 

and other variables, such as your age, gender, 

and body size. If your medical evidence 

includes eGFR findings, we will consider 

them when we evaluate your CKD under 

106.05. 

3. Kidney or bone biopsy. If you have had 

a kidney or bone biopsy, we need a copy of 

the pathology report. When we cannot get a 

copy of the pathology report, we will accept 

a statement from an acceptable medical 

source verifying that a biopsy was performed 

and describing the results. 

C. What other factors do we consider when 

we evaluate your genitourinary disorder? 

1. Chronic hemodialysis or peritoneal 

dialysis. 

a. Dialysis is a treatment for CKD that uses 

artificial means to remove toxic metabolic 

byproducts from the blood. Hemodialysis 

uses an artificial kidney machine to clean 

waste products from the blood; peritoneal 

dialysis uses a dialyzing solution that is 

introduced into and removed from the 

abdomen (peritoneal cavity) either 

continuously or intermittently. Under 106.03, 

your ongoing dialysis must have lasted or be 

expected to last for a continuous period of at 

least 12 months. To satisfy the requirement 

in 106.03, we will accept a report from an 

acceptable medical source that describes 

your CKD and your current dialysis, and 

indicates that your dialysis will be ongoing. 

b. If you are undergoing chronic 

hemodialysis or peritoneal dialysis, your 

CKD may meet our definition of disability 

before you started dialysis. We will 

determine the onset of your disability based 

on the facts in your case record. 

2. Kidney transplant. 

a. If you receive a kidney transplant, we 

will consider you to be disabled under 

106.04 for 1 year from the date of transplant. 

After that, we will evaluate your residual 

impairment(s) by considering your posttransplant function, any rejection episodes 

you have had, complications in other body 

systems, and any adverse effects related to 

ongoing treatment. 

b. If you received a kidney transplant, your 

CKD may meet our definition of disability 

before you received the transplant. We will 

determine the onset of your disability based 

on the facts in your case record. 

3. Anasarca (generalized massive edema or 

swelling). Under 106.06B, we need a 

description of the extent of edema, including 

pretibial (in front of the tibia), periorbital 

(around the eyes), or presacral (in front of the 

sacrum) edema. We also need a description 

of any ascites, pleural effusion, or pericardial 

effusion. 

4. Congenital genitourinary disorder. 

Procedures such as diagnostic cystoscopy or 

circumcision do not satisfy the requirement 

for urologic surgical procedures in 106.07. 

5. Complications of CKD. The 

hospitalizations in 106.09 may be for 

different complications of CKD. Examples of 

complications from CKD that may result in 

hospitalization include stroke, congestive 

heart failure, hypertensive crisis, or acute 

kidney failure requiring a short course of 

hemodialysis. If the CKD complication 

occurs during a hospitalization that was 

initially for a co-occurring condition, we will 

evaluate it under our rules for determining 

medical equivalence. (See § 416.926 of this 

chapter.) We will evaluate co-occurring 

conditions, including those that result in 

hospitalizations, under the listings for the 

affected body system or under our rules for 

medical equivalence. 

D. How do we evaluate disorders that do not 

meet one of the genitourinary listings? 

1. The listed disorders are only examples 

of common genitourinary disorders that we 

consider severe enough to result in marked 

and severe functional limitations. If your 

impairment(s) does not meet the criteria of 

any of these listings, we must also consider 

whether you have an impairment(s) that 

satisfies the criteria of a listing in another 

body system. 

2. If you have a severe medically 

determinable impairment(s) that does not 

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61226 Federal Register / Vol. 79, No. 197 / Friday, October 10, 2014 / Rules and Regulations 

meet a listing, we will determine whether 

your impairment(s) medically equals a 

listing. (See § 416.926 of this chapter.) 

Genitourinary disorders may be associated 

with disorders in other body systems, and we 

consider the combined effects of multiple 

impairments when we determine whether 

they medically equal a listing. If your 

impairment(s) does not medically equal a 

listing, we will also consider whether it 

functionally equals the listings. (See 

§ 416.926a of this chapter.) We use the rules 

in § 416.994a of this chapter when we decide 

whether you continue to be disabled. 

106.01 Category of Impairments, 

Genitourinary Disorders 

106.03 Chronic kidney disease, with 

chronic hemodialysis or peritoneal dialysis 

(see 106.00C1). 

106.04 Chronic kidney disease, with 

kidney transplant. Consider under a 

disability for 1 year following the transplant; 

thereafter, evaluate the residual impairment 

(see 106.00C2). 

106.05 Chronic kidney disease, with 

impairment of kidney function, with one of 

the following documented on at least two 

occasions at least 90 days apart during a 

consecutive 12-month period: 

A. Serum creatinine of 3 mg/dL or greater; 

OR 

B. Creatinine clearance of 30 ml/min/

1.73m2 or less; 

OR 

C. Estimated glomerular filtration rate 

(eGFR) of 30 ml/min/1.73m2 or less. 

106.06 Nephrotic syndrome, with A 

and B: 

A. Laboratory findings as described in 1 or 

2, documented on at least two occasions at 

least 90 days apart during a consecutive 12- 

month period: 

1. Serum albumin of 3.0 g/dL or less, or 

2. Proteinuria of 40 mg/m2/hr or greater; 

AND 

B. Anasarca (see 106.00C3) persisting for at 

least 90 days despite prescribed treatment. 

106.07 Congenital genitourinary disorder 

(see 106.00C4) requiring urologic surgical 

procedures at least three times in a 

consecutive 12-month period, with at least 30 

days between procedures. Consider under a 

disability for 1 year following the date of the 

last surgery; thereafter, evaluate the residual 

impairment. 

106.09 Complications of chronic kidney 

disease (see 106.00C5) requiring at least three 

hospitalizations within a consecutive 12- 

month period and occurring at least 30 days 

apart. Each hospitalization must last at least 

48 hours, including hours in a hospital 

emergency department immediately before 

the hospitalization. 

* * * * * 

[FR Doc. 2014–24114 Filed 10–9–14; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF STATE 

22 CFR Parts 120, 121, 123, 126, and 

130 

[Public Notice 8898] 

RIN 1400–AD64 

Amendment to the International Traffic 

in Arms Regulations: Corrections, 

Clarifications, and Movement of 

Definitions 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: In an effort to streamline, 

simplify and clarify the recent revisions 

to the International Traffic in Arms 

Regulations (ITAR) made pursuant to 

the President’s Export Control Reform 

(ECR) initiative, the Department of State 

is amending the ITAR as part of the 

Department of State’s retrospective plan 

under Executive Order 13563 completed 

on August 17, 2011. 

DATES: This rule is effective October 10, 

2014. 

FOR FURTHER INFORMATION CONTACT: Mr. 

C. Edward Peartree, Director, Office of 

Defense Trade Controls Policy, 

Department of State, telephone (202) 

663–2792; email DDTCResponseTeam@

state.gov. ATTN: Regulatory Change, 

Omnibus Clarifications. The Department 

of State’s full retrospective plan can be 

accessed at http://www.state.gov/

documents/organization/181028.pdf. 

SUPPLEMENTARY INFORMATION: 

Changes in this Rule 

The following changes are made to 

the ITAR with this final rule: (1) 

Definitions previously provided in 

§§ 121.3, 121.4, 121.14, and 121.15 are 

removed from these sections and 

incorporated into U.S. Munitions List 

Categories VIII, VII, XX, and VI, 

respectively; (2) USML Category II is 

amended to clarify that grenade 

launchers are controlled in paragraph 

(a) as a result of the revisions previously 

made to USML Category IV pursuant to 

Export Control Reform; (3) USML 

Category IX is amended to enumerate 

military training not directly related to 

a defense article, which is a controlled 

activity pursuant to ITAR § 120.9(a)(3). 

This change is required in order to 

provide exporters a USML category to 

cite for military training when not 

related to a defense article; (4) The note 

to paragraph (b) in the specially 

designed definition is revised to clarify 

that catch-all controls are only those 

that generically control parts, 

components, accessories, and 

attachments for a specified article and 

do not identify a specific specially 

designed part, component, accessory, or 

attachment. This revision is intended to 

help ensure that exporters properly 

apply ITAR § 120.41 when classifying 

their article and clarify that when a 

specific article is described on the 

USML, it is enumerated and is not part 

of a catch-all; (5) The definitions 

previously provided in ITAR § 121.8 are 

removed to new ITAR § 120.45; (6) The 

policy with regard to when forgings, 

castings, and machined bodies are 

controlled as defense articles is removed 

from ITAR § 121.10 and placed in ITAR 

§ 120.6; (7) The threshold for lithiumion batteries controlled in Category 

VIII(h)(13) is increased from greater than 

28 volts of direct current (VDC) nominal 

to greater than 38 VDC nominal, so as 

not to control on the USML such 

batteries in normal commercial aviation 

use; (8) A control for specially designed 

parts, components, accessories, and 

attachments is added to the helmets 

controlled in Category VIII(h)(15); (9) 

The phrase ‘‘electric-generating’’ is 

added to the control describing fuel 

cells in Category VIII(h)(23) to clarify 

that fuel bladders and fuel tanks are not 

within this control; (10) The word 

‘‘enumerated’’ is replaced with the word 

‘‘described’’ in the paragraphs of the 

USML for technical data and defense 

services directly related to the defense 

articles in that Category to clarify that 

the controls on technical data and 

defense services apply even if the 

defense article is described in a catchall; (11) Conforming changes are made 

to citations throughout these sections; 

and (12) Minor reference corrections are 

made to Supplement No. 1 to Part 126, 

including moving the footnote to the 

entire Supplement from the end to the 

opening to better clarify if an item is 

excluded from eligibility in any row, it 

is excluded from that exemption, even 

if also described in another row that 

contains a description that may also 

include that item. 

Regulatory Analysis and Notices 

Administrative Procedure Act 

The Department of State is of the 

opinion that controlling the import and 

export of defense articles and services is 

a foreign affairs function of the United 

States Government and that rules 

implementing this function are exempt 

from 5 U.S.C. 553 and 554. 

Regulatory Flexibility Act 

Since the Department is of the 

opinion that this rule is exempt from the 

provisions of 5 U.S.C. 553, there is no 

requirement for an analysis under the 

Regulatory Flexibility Act. 

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