19522 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 

Peoria, IL, General Downing—Peoria 

Intl, RNAV (GPS) RWY 4, Amdt 2 

Peoria, IL, General Downing—Peoria 

Intl, RNAV (GPS) RWY 13, Amdt 1A 

Peoria, IL, General Downing—Peoria 

Intl, RNAV (GPS) RWY 22, Amdt 1B 

Peoria, IL, General Downing—Peoria 

Intl, RNAV (GPS) RWY 31, Amdt 1B 

Peoria, IL, General Downing—Peoria 

Intl, Takeoff Minimums and Obstacle 

DP, Amdt 2 

Peoria, IL, Mount Hawley Auxiliary, 

VOR–A, Amdt 4, CANCELED 

Peoria, IL, Mount Hawley Auxiliary, 

VOR/DME–A, Orig 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, ILS OR 

LOC RWY 13, Amdt 27E 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, ILS OR 

LOC RWY 22R, Amdt 11B 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, NDB RWY 

31, Amdt 2D 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, RNAV 

(GPS) RWY 31, Amdt 1D 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, VOR RWY 

4L, Amdt 17C 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, VOR/DME 

RWY 22R, Amdt 8H 

Gonzales, LA, Louisiana Rgnl, RNAV 

(GPS) RWY 17, Amdt 1B 

Gonzales, LA, Louisiana Rgnl, VOR/

DME–A, Amdt 2A 

Lafayette, LA, Lafayette Rgnl, RNAV 

(GPS) RWY 29, Orig-B 

New Roads, LA, False River Rgnl, LOC 

RWY 36, Amdt 1A 

New Roads, LA, False River Rgnl, NDB 

RWY 36, Amdt 2A 

New Roads, LA, False River Rgnl, RNAV 

(GPS) RWY 18, Orig-A 

New Roads, LA, False River Rgnl, RNAV 

(GPS) RWY 36, Orig-A 

New Roads, LA, False River Rgnl, VOR/ 

DME–A, Amdt 4A 

Detroit, MI, Willow Run, Takeoff 

Minimums and Obstacle DP, Amdt 

10A 

Minneapolis, MN, Minneapolis-St Paul 

Intl/Wold-Chamberlain, ILS V RWY 

35 (CONVERGING), Amdt 4 

Minneapolis, MN, Minneapolis-St Paul 

Intl/Wold-Chamberlain, ILS Z OR 

LOC RWY 35, ILS Z RWY 35 (SA CAT 

I), ILS Z RWY 35 (CAT II), ILS Z RWY 

35 (CAT III), Amdt 4 

Minneapolis, MN, Minneapolis-St Paul 

Intl/Wold-Chamberlain, RNAV (GPS) 

Z RWY 30L, Amdt 4 

Minneapolis, MN, Minneapolis-St Paul 

Intl/Wold-Chamberlain, RNAV (GPS) 

Z RWY 35, Amdt 3 

Minneapolis, MN, Minneapolis-St Paul 

Intl/Wold-Chamberlain, RNAV (RNP) 

Y RWY 12L, Orig 

Minneapolis, MN, Minneapolis-St Paul 

Intl/Wold-Chamberlain, RNAV (RNP) 

Y RWY 12R, Orig 

Minneapolis, MN, Minneapolis-St Paul 

Intl/Wold-Chamberlain, RNAV (RNP) 

Y RWY 30L, Orig 

New Ulm, MN, New Ulm Muni, NDB 

RWY 15, Amdt 2A, CANCELED 

New Ulm, MN, New Ulm Muni, NDB 

RWY 33, Amdt 2A, CANCELED 

Steele, MO, Steele Muni, RNAV (GPS) 

RWY 18, Orig 

Steele, MO, Steele Muni, RNAV (GPS) 

RWY 36, Orig 

Steele, MO, Steele Muni, Takeoff 

Minimums and Obstacle DP, Orig 

Billings, MT, Billings Logan Intl, ILS OR 

LOC/DME RWY 28R, Amdt 2 

Billings, MT, Billings Logan Intl, RNAV 

(GPS) Y RWY 10L, Amdt 3 

Billings, MT, Billings Logan Intl, RNAV 

(GPS) Y RWY 28R, Amdt 3 

Billings, MT, Billings Logan Intl, RNAV 

(RNP) Z RWY 28R, Orig 

Kalispell, MT, Glacier Park Intl, ILS OR 

LOC RWY 2, Amdt 7 

Ahoskie, NC, Tri-County, GPS RWY 1, 

Orig, CANCELED 

Ahoskie, NC, Tri-County, GPS RWY 19, 

Orig, CANCELED 

Ahoskie, NC, Tri-County, RNAV (GPS) 

RWY 1, Orig 

Ahoskie, NC, Tri-County, RNAV (GPS) 

RWY 19, Orig 

Ahoskie, NC, Tri-County, VOR/DME–A, 

Amdt 6 

Charlotte, NC, Charlotte/Douglas Intl, 

ILS OR LOC RWY 18L, Amdt 8 

Charlotte, NC, Charlotte/Douglas Intl, 

ILS OR LOC RWY 18R, ILS RWY 18R 

(SA CAT I), ILS RWY 18R (CAT II), 

ILS RWY 18R (CAT III), Amdt 1 

Charlotte, NC, Charlotte/Douglas Intl, 

ILS OR LOC RWY 36L, ILS RWY 36L 

(SA CAT I), ILS RWY 36L (CAT II), 

ILS RWY 36L (CAT III), Amdt 1 

Charlotte, NC, Charlotte/Douglas Intl, 

ILS OR LOC RWY 36R, ILS RWY 36R 

(SA CAT I), ILS RWY 36R (CAT II), 

ILS RWY 36R (CAT III), Amdt 12 

Charlotte, NC, Charlotte/Douglas Intl, 

RNAV (GPS) Y RWY 18L, Amdt 4 

Charlotte, NC, Charlotte/Douglas Intl, 

RNAV (GPS) Y RWY 18R, Amdt 1 

Charlotte, NC, Charlotte/Douglas Intl, 

RNAV (GPS) Y RWY 36L, Amdt 1 

Charlotte, NC, Charlotte/Douglas Intl, 

RNAV (GPS) Y RWY 36R, Amdt 4 

Smithfield, NC, Johnston Regional, ILS 

OR LOC Y RWY 3, Orig 

Smithfield, NC, Johnston Regional, ILS 

OR LOC Z RWY 3, Amdt 2 

Smithfield, NC, Johnston Regional, NDB 

RWY 3, Amdt 2 

Smithfield, NC, Johnston Regional, 

RNAV (GPS) RWY 3, Amdt 1 

Smithfield, NC, Johnston Regional, 

RNAV (GPS) RWY 21, Amdt 1 

Smithfield, NC, Johnston Regional, 

Takeoff Minimums and Obstacle DP, 

Amdt 4 

Curtis, NE., Curtis Muni, RNAV (GPS) 

RWY 12, Orig 

Curtis, NE., Curtis Muni, RNAV (GPS) 

RWY 30, Orig 

Curtis, NE., Curtis Muni, Takeoff 

Minimums and Obstacle DP, Orig 

Oklahoma City, OK, Wiley Post, RNAV 

(GPS) RWY 17L, Amdt 2A 

Houston, TX, Houston Executive, RNAV 

(GPS) RWY 18, Orig-A 

Kingsville, TX, Kleberg County, NDB 

RWY 13, Amdt 6, CANCELED 

New Braunfels, TX, New Braunfels 

Rgnl, RNAV (GPS) RWY 13, Amdt 1 

New Braunfels, TX, New Braunfels 

Rgnl, RNAV (GPS) RWY 31, Amdt 1 

Price, UT, Carbon County Rgnl/Buck 

Davis Field, RNAV (GPS) RWY 1, 

Amdt 2 

Siren, WI, Burnett County, RNAV (GPS) 

RWY 5, Orig 

Siren, WI, Burnett County, RNAV (GPS) 

RWY 14, Orig 

Siren, WI, Burnett County, RNAV (GPS) 

RWY 23, Orig 

Siren, WI, Burnett County, RNAV (GPS) 

RWY 32, Orig 

Siren, WI, Burnett County, VOR RWY 5, 

Amdt 3 

[FR Doc. 2015–08113 Filed 4–10–15; 8:45 am] 

BILLING CODE 4910–13–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Parts 404 and 416 

[Docket No. SSA–2011–0081] 

RIN 0960–AG28 

Revised Listings for Growth Disorders 

and Weight Loss in Children 

AGENCY: Social Security Administration. 

ACTION: Final rule. 

SUMMARY: This rule adopts, with one 

change, the rule for evaluating growth 

disorders in children we proposed in a 

notice of proposed rulemaking (NPRM) 

published in the Federal Register on 

May 22, 2013. Several body systems in 

the Listing of Impairments (listings) 

contain listings for children based on 

impairment of linear growth or weight 

loss. We are replacing those listings 

with new listings for low birth weight 

(LBW) and failure to thrive; a new 

listing for genitourinary impairments; 

and revised listings for growth failure in 

combination with a respiratory, 

cardiovascular, digestive, or immune 

system disorder. These revisions reflect 

our program experience, advances in 

medical knowledge, and comments we 

received from medical experts and the 

public. 

DATES: This rule is effective June 12, 

2015. 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 19523 

1 78 FR at 30350. 

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 adopting, as final, the rule for 

evaluating growth disorders in children 

we proposed in an NPRM published in 

the Federal Register on May 22, 2013 at 

78 FR 30249. We made one addition to 

this rule as the result of a public 

comment suggesting we provide 

guidance for evaluating LBW in 

children born at less than 32 weeks 

gestation or weighing less than 1325 

grams. We revised the table in listing 

100.04B to include 32 weeks in the 

Gestational Age column because we 

believe that this guidance is 

appropriate. 

The preamble to the NPRM discussed 

the remaining changes from our current 

rule and our reasons for proposing those 

changes. To the extent that we are 

adopting the proposed rule 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 

under docket number SSA–2011–0081. 

Why are we revising the listings for 

evaluating growth disorders in 

children? 

We are revising the listings for 

evaluating growth disorders in children 

to update the medical criteria, provide 

more information on how we evaluate 

growth disorders, reflect our program 

experience, and address adjudicator 

questions. 

Public Comments on the NPRM 

In the NPRM, we provided the public 

with a 60-day comment period, which 

ended on July 22, 2013. We received six 

comments. The commenters included 

state agencies that make disability 

determinations for us, the National 

Association of Disability Examiners, 

medical organizations, such as the 

American Academy of Pediatrics, and 

advocacy groups, such as the Endocrine 

Society. We carefully considered all of 

the comments, summarized the 

commenters’ views, and responded to 

all of the significant issues that were 

within the scope of this rule. 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. 

Listing 100.04 Low Birth Weight in 

Infants From Birth to Attainment of Age 

1 

Low Birth Weight 

Comment: One commenter suggested 

that we provide guidance in the listings 

at 100.04A or 100.04B, or in the 

introductory text at 100.00, on diaries 

used to schedule continuing disability 

reviews (CDR) for LBW infants. The 

commenter believes that, while this 

guidance is already in our internal 

operating instructions, providing it in 

the regulations would reduce the 

number of incorrect diaries being set for 

LBW cases. 

Response: We did not adopt this 

comment. In 100.00B, we include a 

reference to our rule for CDRs for LBW 

cases at § 416.990(b)(11). Additionally, 

the Act requires, with one exception, 

that we perform a CDR not later than 12 

months after the birth of an infant 

whose LBW is a contributing factor 

material to the determination that the 

infant is disabled. We will continue to 

provide guidance on diaries for LBW 

cases and cases involving other 

disabling impairments in our internal 

operating instructions. We do not 

believe it is necessary to repeat this 

guidance in the regulation. 

Comment: One commenter expressed 

concern that listing 100.04 suggests that 

LBW is a disability. The commenter felt 

that it should be clear that weight is ‘‘a 

proxy measure for prematurity, 

dysphagia, and other functional 

impairments that are associated with 

disabilities, rather than weight as a 

disability itself.’’ The commenter did 

not provide suggested language to 

include in our rule. 

Response: We did not adopt this 

comment. We agree that, for the 

purposes of listing 100.04, weight is a 

proxy measure for disability in infants 

from birth to the attainment of age 1. 

However, we do not believe that 

providing additional guidance is 

necessary for the clarity of our rule. As 

we noted in the preamble to the 

proposed rule, we based listing 100.04 

on sections 416.926a(m)(6) and (m)(7) of 

our functional equivalence rule.1 Our 

adjudicators have over 20 years of 

experience evaluating claims filed on 

behalf of children based on LBW under 

our functional equivalence rule. In our 

experience applying this rule, we have 

not found that the type of guidance the 

commenter suggested is necessary in 

order to apply the rule properly. 

Evaluating Infants Born at 33 Weeks 

Weighing Less Than 1325 Grams 

Comment: One commenter suggested 

that we add guidance for evaluating 

infants who weigh between 1200 grams 

and 1325 grams, and who are born at 

gestational ages of 32 weeks or less. 

Response: We partially adopted this 

comment. We agree that it is appropriate 

to provide guidance for evaluating LBW 

in infants who are born at 32 weeks 

gestational age. We revised the table in 

100.04B to provide a birth weight value 

of 1250 grams or less for the gestational 

age of 32 weeks. However, we did not 

provide birth weight values for 

gestational ages less than 32 weeks. The 

birth weight values that we would 

provide for infants born at less than 32 

weeks would be less than 1200 grams 

and, thus, the birth weight would meet 

the criterion in 100.04A. 

Listing 100.05 Failure To Thrive in 

Children From Birth to Attainment of 

Age 3 

Growth Measurements 

Comment: One commenter 

recommended including growth curves 

in 100.05A to make administrative 

processing for pediatricians easier. 

Another commenter suggested that we 

make determinations based on growth 

measurements alone without requiring a 

diagnosis of developmental delay. 

Response: We did not adopt these 

comments. In 100.05A, we require three 

weight-for-length measurements or body 

mass index (BMI)-for-age measurements 

that are within a 12-month period, at 

least 60-days apart, and less than the 

third percentile on the appropriate table 

in listing 105.08B.2. The adjudicator 

making the disability determination 

uses the information from growth curves 

provided by the child’s pediatrician to 

find the corresponding values on the 

tables provided. We do not believe it is 

necessary to include the growth curves 

in the listing because our adjudicators 

use the listing, rather than the 

pediatrician who evaluates a child. 

As we stated in the NPRM, our 

program experience has shown that 

growth failure alone is not disabling (78 

FR at 30251). To meet the severity 

requirements for listing 100.05B, the 

child must have growth failure with a 

developmental delay of the appropriate 

severity required by the listing. Children 

with growth failure without 

developmental delay may be evaluated 

in the appropriate body system of the 

underlying condition causing the 

growth failure. 


wreier-aviles on DSK5TPTVN1PROD with RULES
19524 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 

2 78 FR at 30251. 3See 20 CFR 416.926a(a). 4See 20 CFR part 404, subpart P, Appendix 1. 

Developmental Testing 

Comment: One commenter questioned 

the requirement for two narrative 

developmental reports in 100.05C and 

the requirement that these two reports 

be at least 120 days apart. This 

commenter suggested that, if we keep 

the requirement for two reports, we 

should require a shorter period of either 

30 or 60 days between them. Another 

commenter also expressed concern 

about the requirements for the evidence 

of developmental delay. This 

commenter was concerned about the 

availability of these records from 

providers. 

Response: We did not adopt these 

comments. In 100.05C, we require two 

narrative developmental reports when a 

report of a standardized developmental 

assessment required by 100.05B is not 

available. As we explained in the 

NPRM, abnormal findings noted on 

repeated examinations, and information 

in narrative developmental reports, that 

may include the results of 

developmental screening tests, can 

identify a child who is not developing 

or achieving skills within expected 

timeframes.2

We do not believe that 30 or 60 days 

is enough time for these kinds of 

changes to appear on testing. We believe 

that 120 days is an appropriate period 

for developmental testing to be 

performed and to allow for any changes 

in development to show on testing. 

While we understand the 

commenter’s concern about the 

availability of evidence, we believe that, 

for the children whose impairments we 

evaluate under listing 100.05, evidence 

generally will be available from 

providers because these children are 

likely to be identified, and subsequently 

treated because of their identification, 

by early intervention programs. 

Comment: One commenter noted that 

most early intervention programs use ‘‘a 

25 percent delay criteria as opposed to 

the two-thirds criteria’’ required in 

100.05C. However, the commenter did 

not provide any suggestions for 

changing the criterion. 

Response: We did not adopt this 

comment. We recognize that early 

intervention programs often use a 25 

percent delay criterion to determine 

eligibility for intervention services and 

to identify the needed services. In 

contrast, we evaluate a child’s delay to 

determine whether the underlying 

impairment is disabling because it 

results in ‘‘marked and severe 

functional limitations.’’ An impairment 

results in ‘‘marked and severe 

functional limitations’’ only if it meets, 

medically equals, or functionally equals 

the listings. An impairment is of listinglevel severity if it results in ‘‘marked’’ 

limitations in two domains of 

functioning or an ‘‘extreme’’ limitation 

in one domain.3 The level of delay that 

we require in 100.05C is consistent with 

our definition of ‘‘marked limitation’’ in 

§ 416.926a(e)(2)(ii). 

Comment: One commenter expressed 

concern about acceptable timeframes for 

performing developmental testing in 

relation to disability determinations 

stated in 100.05B and 100.05C. The 

commenter suggested that the testing to 

establish the child’s current level of 

development be performed within 6 

months of adjudication. 

Response: We partially adopted this 

comment. We agree that evidence about 

a child’s development must be recent 

and current in relation to a disability 

determination, and we have revised 

listings 100.05B and 100.05C2 to clarify 

this requirement. However, the facts in 

a specific case determine whether the 

evidence is current. Determining factors 

include, but are not limited to, the age 

of the child, the amount of delay, and 

the developmental trajectory 

documented over time. We are not 

setting specific timeframes for when 

developmental testing must be 

performed, but we are specifying that 

the evidence must reflect the child’s 

current development. 

Linear Growth 

Comment: One commenter agreed 

with our use of weight-for-length and 

BMI-for-age charts to evaluate growth 

failure, rather than of linear (height or 

length) growth charts. The commenter 

expressed concern, however, that an 

underlying condition could cause a 

child to have such profound growth 

failure that BMI for the child’s age 

would become normal, despite his or 

her significant growth failure. 

Response: We did not adopt this 

comment. We understand the 

commenter’s concerns that some 

children may have underlying 

conditions that cause linear growth 

impairments while their BMI-for-age 

measurements are normal. After 

attainment of age 2, most children 

without an underlying medical disorder 

follow a growth trajectory that remains 

fairly constant during childhood. 

Our adjudicative experience has 

shown that a declining linear growth 

rate is not always indicative of a 

disabling condition. Short stature, 

length, or height below the third 

percentile, in and of itself, is not a 

medically determinable impairment, 

although it can be the result of a 

medically determinable impairment. We 

will evaluate children with growth 

failure that does not meet the 

requirements of listings 100.04 and 

100.05 and is associated with a known 

medically determinable impairment 

under the affected body system. 

Comment: One commenter was 

concerned that, while the majority of 

children over the age of 3 with growth 

failure have signs and symptoms of an 

underlying disorder in the respiratory, 

cardiovascular, digestive, genitourinary, 

or immune body system, some children 

over the age of 3 will not. This 

commenter suggested that we include 

exceptions for conditions, such as 

Turner syndrome (female 

hypogonadism) and acquired growth 

hormone deficiency, where growth 

failure may be a significant component 

of the disease process. 

Response: We did not adopt this 

comment. After a child attains age 3, we 

will evaluate his or her impairment 

under the affected body system. The two 

examples provided by the commenter 

are endocrine disorders. Although these 

two disorders are not listed impairments 

for children, they may rise to listinglevel severity because of their effects in 

other body systems. As the commenter 

explained, children with Turner 

syndrome may experience 

complications, such as heart disease, to 

a degree that is disabling. We would 

evaluate the complications under the 

affected body system. 

Listing 103.06 Growth Failure Due to 

Any Chronic Respiratory Disorder 

Comment: Two commenters were 

concerned with the requirement for 

oxygen supplementation in 103.06A. 

The commenters noted that some 

respiratory disorders, such as asthma, 

bronchiectasis, and cystic fibrosis, could 

result in listing-level growth failure 

without requiring oxygen 

supplementation. 

Response: We did not adopt these 

comments. We agree with the 

commenters that some respiratory 

disorders could result in listing-level 

growth failure without requiring oxygen 

supplementation; however, we did not 

revise 103.06 as a result. We use other 

listings, such as 103.02, 103.03, and 

103.04, in the respiratory body system 

to evaluate these disorders.4 We believe 

that these respiratory listings, and our 

functional equivalence rule for 

evaluating disability in children, 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 19525 

5See 20 CFR 416.924a and 416.926a. 

6 42 U.S.C. 405(a), 902(a)(5), and 1383(d)(1). 

7This means that we will use this final rule on 

and after its 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 rule that was in effect at the time we issued the 

decisions. If a court reverses our final decision and 

remands a case for further administrative 

proceedings after the effective date of this final rule, 

we will apply this final rule to the entire period at 

issue in the decision we make after the court’s 

remand. 

adequately address the disorders 

referred to by the commenters.5

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

When will we use this final rule? 

We will begin to use this final rule on 

its effective date. We will continue to 

use the current listings until the date 

this final rule becomes effective. We 

will apply the final rule to new 

applications filed on or after the 

effective date of the final rule and to 

claims that are pending on or after the 

effective date.7

How long will this final rule be 

effective? 

This final rule will remain in effect 

for 5 years after the date it becomes 

effective, unless we extend it or revise 

and issue it 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 this final rule meets the 

criteria for a significant regulatory 

action under Executive Order 12866, as 

supplemented by Executive Order 

13563. Therefore, OMB reviewed this 

final rule. 

Regulatory Flexibility Act 

We certify that this final rule would 

not have a significant economic impact 

on a substantial number of small entities 

because they affect individuals only. 

Therefore, a regulatory flexibility 

analysis is not required under the 

Regulatory Flexibility Act, as amended. 

Paperwork Reduction Act 

This final rule does not create any 

new or affect any existing collections 

and, therefore, does not require OMB 

approval under the Paperwork 

Reduction Act. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social Security— 

Disability Insurance; 96.002, Social 

Security—Retirement Insurance; 96.004, 

Social Security—Survivors Insurance; and 

96.006, Supplemental Security Income). 

List of Subjects 

20 CFR Part 404 

Administrative practice and 

procedure; Blind, Disability benefits; 

Old-Age, Survivors, and Disability 

Insurance; Reporting and recordkeeping 

requirements; Social Security. 

20 CFR Part 416 

Administrative practice and 

procedure; Aged, Blind, Disability 

benefits; Public assistance programs; 

Reporting and recordkeeping 

requirements; Supplemental Security 

Income (SSI). 

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 and part 416 subpart I 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), (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 as follows: 

■ a. Revise item 1 of the introductory 

text before part A of appendix 1. 

■ b. Amend part B by revising the body 

system name for section 100.00 in the 

table of contents. 

■ c. Revise sections 100.00 and 100.01 

of part B. 

■ d. Remove sections 100.02 and 100.03 

of part B. 

■ e. Add sections 100.04 and 100.05 of 

part B 

■ f. Add section 103.00F of part B. 

■ g. Add listing 103.06 of part B. 

■ h. Revise section 104.00C2b 

introductory text of part B. 

■ i. Revise section 104.00C2b(ii) of part 

B. 

■ j. Add section 104.00C3 of part B. 

■ k. Revise listing 104.02C of part B. 

■ l. Revise section 105.00G of part B. 

■ m. Revise listing 105.08 of part B. 

■ n. Redesignate section 106.00C5 of 

part B as 106.00C6 and add new section 

106.00C5. 

■ o. Add listing 106.08 of part B. 

■ p. Add section 114.00F4d of part B. 

■ q. Revise listing 114.08H of part B. 

The revisions and additions read as 

follows: 

APPENDIX 1 TO SUBPART P OF PART 

404—LISTING OF IMPAIRMENTS 

* * * * * 

1. Low Birth Weight and Failure to Thrive 

(100.00): June 12, 2020. 

* * * * * 

Part B 

* * * * * 

100.00 Low Birth Weight and Failure to 

Thrive. 

* * * * * 

100.00 LOW BIRTH WEIGHT AND 

FAILURE TO THRIVE 

A. What conditions do we evaluate under 

these listings? We evaluate low birth weight 

(LBW) in infants from birth to attainment of 

age 1 and failure to thrive (FTT) in infants 

and toddlers from birth to attainment of age 

3. 

B. How do we evaluate disability based on 

LBW under 100.04? In 100.04A and 100.04B, 

we use an infant’s birth weight as 

documented by an original or certified copy 

of the infant’s birth certificate or by a medical 

record signed by a physician. Birth weight 

means the first weight recorded after birth. In 

100.04B, gestational age is the infant’s age 

based on the date of conception as recorded 

in the medical record. If the infant’s 

impairment meets the requirements for 

listing 100.04A or 100.04B, we will follow 

the rule in § 416.990(b)(11) of this chapter. 

C. How do we evaluate disability based on 

FTT under 100.05? 

1. General. We establish FTT with or 

without a known cause when we have 

documentation of an infant’s or a toddler’s 

growth failure and developmental delay from 

an acceptable medical source(s) as defined in 

§ 416.913(a) of this chapter. We require 

documentation of growth measurements in 

100.05A and developmental delay described 

in 100.05B or 100.05C within the same 

consecutive 12-month period. The dates of 

developmental testing and reports may be 

different from the dates of growth 

measurements. After the attainment of age 3, 

we evaluate growth failure under the affected 

body system(s). 

2. Growth failure. Under 100.05A, we use 

the appropriate table(s) under 105.08B in the 

digestive system to determine whether a 

child’s growth is less than the third 

percentile. The child does not need to have 

a digestive disorder for purposes of 100.05. 

a. For children from birth to attainment of 

age 2, we use the weight-for-length table 

corresponding to the child’s gender (Table I 

or Table II). 

b. For children age 2 to attainment of age 

3, we use the body mass index (BMI)-for-age 

table corresponding to the child’s gender 

(Table III or Table IV). 


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c. BMI is the ratio of a child’s weight to the 

square of his or her height. We calculate BMI 

using the formulas in 105.00G2c. 

d. Growth measurements. The weight-forlength measurements for children from birth 

to the attainment of age 2 and BMI-for-age 

measurements for children age 2 to 

attainment of age 3 that are required for this 

listing must be obtained within a 12-month 

period and at least 60 days apart. If a child 

attains age 2 during the evaluation period, 

additional measurements are not needed. 

Any measurements taken before the child 

attains age 2 can be used to evaluate the 

impairment under the appropriate listing for 

the child’s age. If the child attains age 3 

during the evaluation period, the 

measurements can be used to evaluate the 

impairment in the affected body system. 

3. Developmental delay. 

a. Under 100.05B and C, we use reports 

from acceptable medical sources to establish 

delay in a child’s development. 

b. Under 100.05B, we document the 

severity of developmental delay with results 

from a standardized developmental 

assessment, which compares a child’s level 

of development to the level typically 

expected for his or her chronological age. If 

the child was born prematurely, we may use 

the corrected chronological age (CCA) for 

comparison. (See § 416.924b(b) of this 

chapter.) CCA is the chronological age 

adjusted by a period of gestational 

prematurity. CCA = (chronological age)— 

(number of weeks premature). Acceptable 

medical sources or early intervention 

specialists, physical or occupational 

therapists, and other sources may conduct 

standardized developmental assessments and 

developmental screenings. The results of 

these tests and screenings must be 

accompanied by a statement or records from 

an acceptable medical source who 

established the child has a developmental 

delay. 

c. Under 100.05C, when there are no 

results from a standardized developmental 

assessment in the case record, we need 

narrative developmental reports from the 

child’s medical sources in sufficient detail to 

assess the severity of his or her 

developmental delay. A narrative 

developmental report is based on clinical 

observations, progress notes, and well-baby 

check-ups. To meet the requirements for 

100.05C, the report must include: The child’s 

developmental history; examination findings 

(with abnormal findings noted on repeated 

examinations); and an overall assessment of 

the child’s development (that is, more than 

one or two isolated skills) by the medical 

source. Some narrative developmental 

reports may include results from 

developmental screening tests, which can 

identify a child who is not developing or 

achieving skills within expected timeframes. 

Although medical sources may refer to 

screening test results as supporting evidence 

in the narrative developmental report, 

screening test results alone cannot establish 

a diagnosis or the severity of developmental 

delay. 

D. How do we evaluate disorders that do 

not meet one of these listings? 

1. We may find infants disabled due to 

other disorders when their birth weights are 

greater than 1200 grams but less than 2000 

grams and their weight and gestational age do 

not meet listing 100.04. The most common 

disorders of prematurity and LBW include 

retinopathy of prematurity (ROP), chronic 

lung disease of infancy (CLD, previously 

known as bronchopulmonary dysplasia, or 

BPD), intraventricular hemorrhage (IVH), 

necrotizing enterocolitis (NEC), and 

periventricular leukomalacia (PVL). Other 

disorders include poor nutrition and growth 

failure, hearing disorders, seizure disorders, 

cerebral palsy, and developmental disorders. 

We evaluate these disorders under the 

affected body systems. 

2. We may evaluate infants and toddlers 

with growth failure that is associated with a 

known medical disorder under the body 

system of that medical disorder, for example, 

the respiratory or digestive body systems. 

3. If an infant or toddler has a severe 

medically determinable impairment(s) that 

does not meet the criteria of any listing, we 

must also consider whether the child has an 

impairment(s) that medically equals a listing 

(see § 416.926 of this chapter). If the child’s 

impairment(s) does not meet or medically 

equal a listing, we will determine whether 

the child’s impairment(s) functionally equals 

the listings (see § 416.926a of this chapter) 

considering the factors in § 416.924a of this 

chapter. We use the rule in § 416.994a of this 

chapter when we decide whether a child 

continues to be disabled. 

100.01 Category of Impairments, Low Birth 

Weight and Failure to Thrive 

100.04 Low birth weight in infants from 

birth to attainment of age 1. 

A. Birth weight (see 100.00B) of less than 

1200 grams. 

OR 

B. The following gestational age and birth 

weight: 

Gestational 

age 

(in weeks) 

Birth weight 

37–40 .......... 2000 grams or less. 

36 ................ 1875 grams or less. 

35 ................ 1700 grams or less. 

34 ................ 1500 grams or less. 

33 ................ 1325 grams or less. 

32 ................ 1250 grams or less. 

100.05 Failure to thrive in children from 

birth to attainment of age 3 (see 100.00C), 

documented by A and B, or A and C. 

A. Growth failure as required in 1 or 2: 

1. For children from birth to attainment of 

age 2, three weight-for-length measurements 

that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate weight-for-length table in listing 

105.08B1; or 

2. For children age 2 to attainment of age 

3, three BMI-for-age measurements that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate BMI-for-age table in listing 

105.08B2. 

AND 

B. Developmental delay (see 100.00C1 and 

C3), established by an acceptable medical 

source and documented by findings from one 

current report of a standardized 

developmental assessment (see 100.00C3b) 

that: 

1. Shows development not more than twothirds of the level typically expected for the 

child’s age; or 

2. Results in a valid score that is at least 

two standard deviations below the mean. 

OR 

C. Developmental delay (see 100.00C3), 

established by an acceptable medical source 

and documented by findings from two 

narrative developmental reports (see 

100.00C3c) that: 

1. Are dated at least 120 days apart (see 

100.00C1); and 

2. Indicate current development not more 

than two-thirds of the level typically 

expected for the child’s age. 

* * * * * 

103.00 RESPIRATORY SYSTEM 

* * * * * 

F. How do we evaluate growth failure due 

to any chronic respiratory disorder? 

1. To evaluate growth failure due to any 

chronic respiratory disorder, we require 

documentation of the oxygen 

supplementation described in 103.06A and 

the growth measurements in 103.06B within 

the same consecutive 12-month period. The 

dates of oxygen supplementation may be 

different from the dates of growth 

measurements. 

2. Under 103.06B, we use the appropriate 

table(s) under 105.08B in the digestive 

system to determine whether a child’s growth 

is less than the third percentile. 

a. For children from birth to attainment of 

age 2, we use the weight-for-length table 

corresponding to the child’s gender (Table I 

or Table II). 

b. For children age 2 to attainment of age 

18, we use the body mass index (BMI)-for-age 

table corresponding to the child’s gender 

(Table III or Table IV). 

c. BMI is the ratio of a child’s weight to the 

square of his or her height. We calculate BMI 

using the formulas in 105.00G2c. 

* * * * * 

103.06 Growth failure due to any chronic 

respiratory disorder (see 103.00F), 

documented by: 

A. Hypoxemia with the need for at least 1.0 

L/min of oxygen supplementation for at least 

4 hours per day and for at least 90 

consecutive days. 

AND 

B. Growth failure as required in 1 or 2: 

1. For children from birth to attainment of 

age 2, three weight-for-length measurements 

that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate weight-for-length table under 

105.08B1; or 

2. For children age 2 to attainment of age 

18, three BMI-for-age measurements that are: 


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Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 19527 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate BMI-for-age table under 

105.08B2. 

* * * * * 

104.00 CARDIOVASCULAR SYSTEM 

* * * * * 

C. Evaluating Chronic Heart Failure 

* * * * * 

2. What evidence of CHF do we need? 

* * * * * 

b. To establish that you have chronic heart 

failure, we require that your medical history 

and physical examination describe 

characteristic symptoms and signs of 

pulmonary or systemic congestion or of 

limited cardiac output associated with 

abnormal findings on appropriate medically 

acceptable imaging. When a remediable 

factor, such as arrhythmia, triggers an acute 

episode of heart failure, you may experience 

restored cardiac function, and a chronic 

impairment may not be present. 

* * * * * 

(ii) During infancy, other manifestations of 

chronic heart failure may include repeated 

lower respiratory tract infections. 

* * * * * 

3. How do we evaluate growth failure due 

to CHF? 

a. To evaluate growth failure due to CHF, 

we require documentation of the clinical 

findings of CHF described in 104.00C2 and 

the growth measurements in 104.02C within 

the same consecutive 12-month period. The 

dates of clinical findings may be different 

from the dates of growth measurements. 

b. Under 104.02C, we use the appropriate 

table(s) under 105.08B in the digestive 

system to determine whether a child’s growth 

is less than the third percentile. 

(i) For children from birth to attainment of 

age 2, we use the weight-for-length table 

corresponding to the child’s gender (Table I 

or Table II). 

(ii) For children age 2 to attainment of age 

18, we use the body mass index (BMI)-for-age 

table corresponding to the child’s gender 

(Table III or Table IV). 

(iii) BMI is the ratio of a child’s weight to 

the square of his or her height. We calculate 

BMI using the formulas in 105.00G2c. 

* * * * * 

104.02 * * * 

* * * * * 

C. Growth failure as required in 1 or 2: 

1. For children from birth to attainment of 

age 2, three weight-for-length measurements 

that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate weight-for-length table under 

105.08B1; or 

2. For children age 2 to attainment of age 

18, three BMI-for-age measurements that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate BMI-for-age table under 

105.08B2. 

* * * * * 

105.00 DIGESTIVE SYSTEM 

* * * * * 

G. How do we evaluate growth failure due 

to any digestive disorder? 

1. To evaluate growth failure due to any 

digestive disorder, we require documentation 

of the laboratory findings of chronic 

nutritional deficiency described in 105.08A 

and the growth measurements in 105.08B 

within the same consecutive 12-month 

period. The dates of laboratory findings may 

be different from the dates of growth 

measurements. 

2. Under 105.08B, we evaluate a child’s 

growth failure by using the appropriate table 

for age and gender. 

a. For children from birth to attainment of 

age 2, we use the weight-for-length table (see 

Table I or Table II). 

b. For children age 2 to attainment of age 

18, we use the body mass index (BMI)-for-age 

table (see Tables III or IV). 

c. BMI is the ratio of a child’s weight to the 

square of the child’s height. We calculate 

BMI using one of the following formulas: 

English Formula 

BMI = [Weight in Pounds/(Height in Inches 

× Height in Inches)] × 703 

Metric Formulas 

BMI = Weight in Kilograms/(Height in 

Meters × Height in Meters) 

BMI = [Weight in Kilograms/(Height in 

Centimeters × Height in Centimeters)] × 

10,000 

* * * * * 

105.08 Growth failure due to any 

digestive disorder (see 105.00G), documented 

by A and B: 

A. Chronic nutritional deficiency present 

on at least two evaluations at least 60 days 

apart within a consecutive 12-month period 

documented by one of the following: 

1. Anemia with hemoglobin less than 10.0 

g/dL; or 

2. Serum albumin of 3.0 g/dL or less; 

AND 

B. Growth failure as required in 1 or 2: 

1. For children from birth to attainment of 

age 2, three weight-for-length measurements 

that are: 

a. Within a 12-month period; and 

b. At least 60 days apart; and 

c. Less than the third percentile on Table 

I or Table II; or 

TABLE I—MALES BIRTH TO ATTAINMENT OF AGE 2 

[Third Percentile Values for Weight-for-Length] 

Length 

(centimeters) 

Weight 

(kilograms) 

Length 

(centimeters) 

Weight 

(kilograms) 

Length 

(centimeters) 

Weight 

(kilograms) 

45.0 .................................................................. 1.597 64.5 6.132 84.5 10.301 

45.5 .................................................................. 1.703 65.5 6.359 85.5 10.499 

46.5 .................................................................. 1.919 66.5 6.584 86.5 10.696 

47.5 .................................................................. 2.139 67.5 6.807 87.5 10.895 

48.5 .................................................................. 2.364 68.5 7.027 88.5 11.095 

49.5 .................................................................. 2.592 69.5 7.245 89.5 11.296 

50.5 .................................................................. 2.824 70.5 7.461 90.5 11.498 

51.5 .................................................................. 3.058 71.5 7.674 91.5 11.703 

52.5 .................................................................. 3.294 72.5 7.885 92.5 11.910 

53.5 .................................................................. 3.532 73.5 8.094 93.5 12.119 

54.5 .................................................................. 3.771 74.5 8.301 94.5 12.331 

55.5 .................................................................. 4.010 75.5 8.507 95.5 12.546 

56.5 .................................................................. 4.250 76.5 8.710 96.5 12.764 

57.5 .................................................................. 4.489 77.5 8.913 97.5 12.987 

58.5 .................................................................. 4.728 78.5 9.113 98.5 13.213 

59.5 .................................................................. 4.966 79.5 9.313 99.5 13.443 

60.5 .................................................................. 5.203 80.5 9.512 100.5 13.678 

61.5 .................................................................. 5.438 81.5 9.710 101.5 13.918 

62.5 .................................................................. 5.671 82.5 9.907 102.5 14.163 

63.5 .................................................................. 5.903 83.5 10.104 103.5 14.413 


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19528 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 

TABLE II—FEMALES BIRTH TO ATTAINMENT OF AGE 2 

[Third Percentile Values for Weight-for-Length] 

Length 

(centimeters) 

Weight 

(kilograms) 

Length 

(centimeters) 

Weight 

(kilograms) 

Length 

(centimeters) 

Weight 

(kilograms) 

45.0 .................................................................. 1.613 64.5 5.985 84.5 10.071 

45.5 .................................................................. 1.724 65.5 6.200 85.5 10.270 

46.5 .................................................................. 1.946 66.5 6.413 86.5 10.469 

47.5 .................................................................. 2.171 67.5 6.625 87.5 10.670 

48.5 .................................................................. 2.397 68.5 6.836 88.5 10.871 

49.5 .................................................................. 2.624 69.5 7.046 89.5 11.074 

50.5 .................................................................. 2.852 70.5 7.254 90.5 11.278 

51.5 .................................................................. 3.081 71.5 7.461 91.5 11.484 

52.5 .................................................................. 3.310 72.5 7.667 92.5 11.691 

53.5 .................................................................. 3.538 73.5 7.871 93.5 11.901 

54.5 .................................................................. 3.767 74.5 8.075 94.5 12.112 

55.5 .................................................................. 3.994 75.5 8.277 95.5 12.326 

56.5 .................................................................. 4.220 76.5 8.479 96.5 12.541 

57.5 .................................................................. 4.445 77.5 8.679 97.5 12.760 

58.5 .................................................................. 4.892 78.5 8.879 98.5 12.981 

59.5 .................................................................. 5.113 79.5 9.078 99.5 13.205 

60.5 .................................................................. 5.333 80.5 9.277 100.5 13.431 

61.5 .................................................................. 5.552 81.5 9.476 101.5 13.661 

62.5 .................................................................. 5.769 82.5 9.674 102.5 13.895 

63.5 .................................................................. 5.769 83.5 9.872 103.5 14.132 

2. For children age 2 to attainment of age 

18, three BMI-for-age measurements that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on Table 

III or Table IV. 

TABLE III—MALES AGE 2 TO ATTAINMENT OF AGE 18 

[Third Percentile Values for BMI-for-Age] 

Age 

(yrs. and 

mos.) 

BMI Age 

(yrs. and mos.) BMI Age (yrs. and mos.) BMI 

2.0 to 2.1 ...... 14.5 10.11 to 11.2 14.3 14.9 to 14.10 16.1 

2.2 to 2.4 ...... 14.4 11.3 to 11.5 14.4 14.11 to 15.0 16.2 

2.5 to 2.7 ...... 14.3 11.6 to 11.8 14.5 15.1 to 15.3 16.3 

2.8 to 2.11 .... 14.2 11.9 to 11.11 14.6 15.4 to 15.5 16.4 

3.0 to 3.2 ...... 14.1 12.0 to 12.1 14.7 15.6 to 15.7 16.5 

3.3 to 3.6 ...... 14.0 12.2 to 12.4 14.8 15.8 to 15.9 16.6 

3.7 to 3.11 .... 13.9 12.5 to 12.7 14.9 15.10 to 15.11 16.7 

4.0 to 4.5 ...... 13.8 12.8 to 12.9 15.0 16.0 to 16.1 16.8 

4.6 to 5.0 ...... 13.7 12.10 to 13.0 15.1 16.2 to 16.3 16.9 

5.1 to 6.0 ...... 13.6 13.1 to 13.2 15.2 16.4 to 16.5 17.0 

6.1 to 7.6 ...... 13.5 13.3 to 13.4 15.3 16.6 to 16.8 17.1 

7.7 to 8.6 ...... 13.6 13.5 to 13.7 15.4 16.9 to 16.10 17.2 

8.7 to 9.1 ...... 13.7 13.8 to 13.9 15.5 16.11 to 17.0 17.3 

9.2 to 9.6 ...... 13.8 13.10 to 13.11 15.6 17.1 to 17.2 17.4 

9.7 to 9.11 .... 13.9 14.0 to 14.1 15.7 17.3 to 17.5 17.5 

10.0 to 10.3 .. 14.0 14.2 to 14.4 15.8 17.6 to 17.7 17.6 

10.4 to 10.7 .. 14.1 14.5 to 14.6 15.9 17.8 to 17.9 17.7 

10.8 to 10.10 14.2 14.7 to 14.8 16.0 17.10 to 17.11 17.8 

TABLE IV—FEMALES AGE 2 TO ATTAINMENT OF AGE 18 

[Third Percentile Values for BMI-for-Age] 

Age 

(yrs. and mos.) BMI Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI 

2.0 to 2.2 .......................................................................................................... 14.1 10.8 to 10.10 14.0 14.3 to 14.5 15.6 

2.3 to 2.6 .......................................................................................................... 14.0 10.11 to 11.2 14.1 14.6 to 14.7 15.7 

2.7 to 2.10 ........................................................................................................ 13.9 11.3 to 11.5 14.2 14.8 to 14.9 15.8 

2.11 to 3.2 ........................................................................................................ 13.8 11.6 to 11.7 14.3 14.10 to 15.0 15.9 

3.3 to 3.6 .......................................................................................................... 13.7 11.8 to 11.10 14.4 15.1 to 15.2 16.0 

3.7 to 3.11 ........................................................................................................ 13.6 11.11 to 12.1 14.5 15.3 to 15.5 16.1 

4.0 to 4.4 .......................................................................................................... 13.5 12.2 to 12.4 14.6 15.6 to 15.7 16.2 

4.5 to 4.11 ........................................................................................................ 13.4 12.5 to 12.6 14.7 15.8 to 15.10 16.3 

5.0 to 5.9 .......................................................................................................... 13.3 12.7 to 12.9 14.8 15.11 to 16.0 16.4 

5.10 to 7.6 ........................................................................................................ 13.2 12.10 to 12.11 14.9 16.1 to 16.3 16.5 


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TABLE IV—FEMALES AGE 2 TO ATTAINMENT OF AGE 18—Continued 

[Third Percentile Values for BMI-for-Age] 

Age 

(yrs. and mos.) BMI Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI 

7.7 to 8.4 .......................................................................................................... 13.3 13.0 to 13.2 15.0 16.4 to 16.6 16.6 

8.5 to 8.10 ........................................................................................................ 13.4 13.3 to 13.4 15.1 16.7 to 16.9 16.7 

8.11 to 9.3 ........................................................................................................ 13.5 13.5 to 13.7 15.2 16.10 to 17.0 16.8 

9.4 to 9.8 .......................................................................................................... 13.6 13.8 to 13.9 15.3 17.1 to 17.3 16.9 

9.9 to 10.0 ........................................................................................................ 13.7 13.10 to 14.0 15.4 17.4 to 17.7 17.0 

10.1 to 10.4 ...................................................................................................... 13.8 14.1 to 14.2 15.5 17.8 to 17.11 17.1 

10.5 to 10.7 ...................................................................................................... 13.9 

* * * * * 

106.00 GENITOURINARY IMPAIRMENTS 

* * * * * 

C. What other factors do we consider when 

we evaluate your genitourinary disorder? 

* * * * * 

5. Growth failure due to any chronic renal 

disease. 

a. To evaluate growth failure due to any 

chronic renal disease, we require 

documentation of the laboratory findings 

described in 106.08A and the growth 

measurements in 106.08B within the same 

consecutive 12-month period. The dates of 

laboratory findings may be different from the 

dates of growth measurements. 

b. Under 106.08B, we use the appropriate 

table(s) under 105.08B in the digestive 

system to determine whether a child’s growth 

is less than the third percentile. 

(i) For children from birth to attainment of 

age 2, we use the weight-for-length table 

corresponding to the child’s gender (Table I 

or Table II). 

(ii) For children age 2 to attainment of age 

18, we use the body mass index (BMI)-for-age 

table corresponding to the child’s gender 

(Table III or Table IV). 

(iii) BMI is the ratio of a child’s weight to 

the square of his or her height. We calculate 

BMI using the formulas in 105.00G2c. 

* * * * * 

106.08 Growth failure due to any chronic 

renal disease (see 106.00C5), with: 

A. Serum creatinine of 2 mg/dL or greater, 

documented at least two times within a 

consecutive 12-month period with at least 60 

days between measurements. 

AND 

B. Growth failure as required in 1 or 2: 

1. For children from birth to attainment of 

age 2, three weight-for-length measurements 

that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate weight-for-length table under 

105.08B1; or 

2. For children age 2 to attainment of age 

18, three BMI-for-age measurements that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate BMI-for-age table under 

105.08B2. 

* * * * * 

114.00 IMMUNE SYSTEM DISORDERS 

* * * * * 

F. * * * 

* * * * * 

4. HIV infection manifestations specific to 

children. 

* * * * * 

d. Growth failure due to HIV immune 

suppression. 

(i) To evaluate growth failure due to HIV 

immune suppression, we require 

documentation of the laboratory values 

described in 114.08H1 and the growth 

measurements in 114.08H2 or 114.08H3 

within the same consecutive 12-month 

period. The dates of laboratory findings may 

be different from the dates of growth 

measurements. 

(ii) Under 114.08H2 and 114.08H3, we use 

the appropriate table under 105.08B in the 

digestive system to determine whether a 

child’s growth is less than the third 

percentile. 

(A) For children from birth to attainment 

of age 2, we use the weight-for-length table 

corresponding to the child’s gender (Table I 

or Table II). 

(B) For children age 2 to attainment of age 

18, we use the body mass index (BMI)-for-age 

table corresponding to the child’s gender 

(Table III or Table IV). 

(C) BMI is the ratio of a child’s weight to 

the square of his or her height. We calculate 

BMI using the formulas in 105.00G2c. 

* * * * * 

114.08 * * * 

* * * * * 

H. Immune suppression and growth failure 

(see 114.00F4d) documented by 1 and 2, or 

by 1 and 3. 

1. CD4 measurement: 

a. For children from birth to attainment of 

age 5, CD4 percentage of less than 20 percent; 

or 

b. For children age 5 to attainment of age 

18, absolute CD4 count of less than 200 cells/ 

mm3, or CD4 percentage of less than 14 

percent; and 

2. For children from birth to attainment of 

age 2, three weight-for-length measurements 

that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate weight-for-length table under 

105.08B1; or 

3. For children age 2 to attainment of age 

18, three BMI-for-age measurements that are: 

a. Within a consecutive 12-month period; 

and 

b. At least 60 days apart; and 

c. Less than the third percentile on the 

appropriate BMI-for-age table under 

105.08B2. 

* * * * * 

PART 416—SUPPLEMENTAL 

SECURITY INCOME FOR THE AGED, 

BLIND, AND DISABLED 

Subpart I—[Amended] 

■ 3. The authority citation for subpart I 

of part 416 continues to read as follows: 

Authority: Secs. 221(m), 702(a)(5), 1611, 

1614, 1619, 1631(a), (c), (d)(1), and (p), and 

1633 of the Social Security Act (42 U.S.C. 

421(m), 902(a)(5), 1382, 1382c, 1382h, 

1383(a), (c), (d)(1), and (p), and 1383b); secs. 

4(c) and 5, 6(c)–(e), 14(a), and 15, Pub. L. 98– 

460, 98 Stat. 1794, 1801, 1802, and 1808 (42 

U.S.C. 421 note, 423 note, and 1382h note). 

■ 4. Amend § 416.924b by revising 

paragraph (b) to read as follows: 

§ 416.924b Age as a factor of evaluation in 

the sequential evaluation process for 

children. 

* * * * * 

(b) Correcting chronological age of 

premature infants. We generally use 

chronological age (a child’s age based on 

birth date) when we decide whether, or 

the extent to which, a physical or 

mental impairment or combination of 

impairments causes functional 

limitations. However, if you were born 

prematurely, we may consider you 

younger than your chronological age 

when we evaluate your development. 

We may use a ‘‘corrected’’ chronological 

age (CCA); that is, your chronological 

age adjusted by a period of gestational 

prematurity. We consider an infant born 

at less than 37 weeks’ gestation to be 

born prematurely. 

(1) We compute your CCA by 

subtracting the number of weeks of 

prematurity (the difference between 40 

weeks of full-term gestation and the 

number of actual weeks of gestation) 

from your chronological age. For 

example, if your chronological age is 20 


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19530 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 

weeks but you were born at 32 weeks 

gestation (8 weeks premature), then 

your CCA is 12 weeks. 

(2) We evaluate developmental delay 

in a premature child until the child’s 

prematurity is no longer a relevant 

factor, generally no later than about 

chronological age 2. 

(i) If you have not attained age 1 and 

were born prematurely, we will assess 

your development using your CCA. 

(ii) If you are over age 1 and have a 

developmental delay, and prematurity is 

still a relevant factor, we will decide 

whether to correct your chronological 

age. We will base our decision on our 

judgment and all the facts in your case. 

If we decide to correct your 

chronological age, we may correct it by 

subtracting the full number of weeks of 

prematurity or a lesser number of 

weeks. If your developmental delay is 

the result of your medically 

determinable impairment(s) and is not 

attributable to your prematurity, we will 

decide not to correct your chronological 

age. 

(3) Notwithstanding the provisions in 

paragraph (b)(1) of this section, we will 

not compute a CCA if the medical 

evidence shows that your treating 

source or other medical source has 

already taken your prematurity into 

consideration in his or her assessment 

of your development. We will not 

compute a CCA when we find you 

disabled under listing 100.04 of the 

Listing of Impairments. 

§ 416.926a [Amended] 

■ 5. Amend § 416.926a by removing 

paragraphs (m)(6) and (m)(7) and 

redesignating paragraph (m)(8) as (m)(6). 

■ 6. Amend § 416.934 by adding 

paragraphs (j) and (k) to read as follows: 

§ 416.934 Impairments which may warrant 

a finding of presumptive disability or 

presumptive blindness. 

* * * * * 

(j) Infants weighing less than 1200 

grams at birth, until attainment of 1 year 

of age. 

(k) Infants weighing at least 1200 but 

less than 2000 grams at birth, and who 

are small for gestational age, until 

attainment of 1 year of age. (Small for 

gestational age means a birth weight that 

is at or more than 2 standard deviations 

below the mean or that is less than the 

third growth percentile for the 

gestational age of the infant.) 

[FR Doc. 2015–08185 Filed 4–10–15; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1020 

[Docket No. FDA–2015–N–0828] 

Performance Standards for Ionizing 

Radiation Emitting Products; 

Fluoroscopic Equipment; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending a 

Federal performance standard for 

ionizing radiation to correct a drafting 

error regarding fluoroscopic equipment 

measurement. We are taking this action 

to ensure clarity and improve the 

accuracy of the regulations. 

DATES: This rule is effective August 26, 

2015. Submit electronic or written 

comments on this direct final rule or its 

companion proposed rule by June 29, 

2015. 

ADDRESSES: You may submit comments 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written comments in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2015–N–0828 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Scott Gonzalez, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4641, Silver Spring, 

MD 20993–0002, 301–796–5889. 

SUPPLEMENTARY INFORMATION: 

I. What is the background of this Rule? 

FDA is correcting a drafting error 

regarding fluoroscopic equipment 

measurement in § 1020.32 (21 CFR 

1020.32). We are publishing this direct 

final rule because it is intended to make 

a noncontroversial amendment to 

§ 1020.32, and we do not anticipate any 

significant adverse comments. 

Specifically, this amendment changes 

the words ‘‘any linear dimension’’ in the 

current regulation to read ‘‘every linear 

dimension’’ (§ 1020.32(b)(4)(ii)(A)). The 

alternative performance standard, 

§ 1020.32(b)(4)(ii)(B), currently contains 

the same phrase but remains 

unchanged. We are amending the 

language to make the performance 

standards mutually exclusive. This will 

ensure clarity and improve the accuracy 

of the regulations. 

FDA first proposed the performance 

standards in the Federal Register of 

December 10, 2002 (67 FR 76056), to 

account for technological changes in 

fluoroscopic equipment. The proposed 

rule did not specify which measurement 

of the visible area of an image receptor 

determined the applicable performance 

standard (67 FR 76056 at 76092). When 

we addressed comments to the proposed 

rule in the Federal Register of June 10, 

2005, we agreed with one comment that 

adding the words ‘‘any linear 

dimension’’ would clarify the 

determination of the performance 

standard (70 FR 33998 at 34007). 

FDA ultimately incorporated the 

phrase in two places, potentially 

reducing the clarity of the rule (70 FR 

33998 at 34040). Section 

1020.32(b)(4)(ii) sets performance 

standards based on a threshold, so the 

language for each standard should be 

mutually exclusive. That is, only one 

standard, and not the other, should 

apply to the image receptor in question. 

However, some image receptors may 

have linear dimensions that are both 

greater than and less than 34 cm, for 

example, receptors with a hexagonal 

shape. In such cases, the performance 

standards may not be mutually 

exclusive, so both standards may appear 

to apply. This direct final rule amends 

§ 1020.32(b)(4)(ii)(A) to read ‘‘every 

linear dimension’’ to ensure the 

standards are mutually exclusive. The 

amendment will improve the clarity and 

accuracy of the regulations. 


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