80_FR_19592 80 FR 19522 - Revised Listings for Growth Disorders and Weight Loss in Children

80 FR 19522 - Revised Listings for Growth Disorders and Weight Loss in Children

SOCIAL SECURITY ADMINISTRATION

Federal Register Volume 80, Issue 70 (April 13, 2015)

Page Range19522-19530
FR Document2015-08185

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.

Federal Register, Volume 80 Issue 70 (Monday, April 13, 2015)
[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Rules and Regulations]
[Pages 19522-19530]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08185]


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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.

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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.

[[Page 19523]]


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 Sec.  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.
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    \1\ 78 FR at 30350.
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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.

[[Page 19524]]

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\
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    \2\ 78 FR at 30251.
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    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 listing-level 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 Sec.  
416.926a(e)(2)(ii).
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    \3\ See 20 CFR 416.926a(a).
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    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 listing-level 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,

[[Page 19525]]

adequately address the disorders referred to by the commenters.\5\
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    \4\ See 20 CFR part 404, subpart P, Appendix 1.
    \5\ See 20 CFR 416.924a and 416.926a.
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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\
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    \6\ 42 U.S.C. 405(a), 902(a)(5), and 1383(d)(1).
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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\
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    \7\ This 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.
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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-)

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

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


0
2. Amend appendix 1 to subpart P of part 404 as follows:
0
a. Revise item 1 of the introductory text before part A of appendix 1.
0
b. Amend part B by revising the body system name for section 100.00 in 
the table of contents.
0
c. Revise sections 100.00 and 100.01 of part B.
0
d. Remove sections 100.02 and 100.03 of part B.
0
e. Add sections 100.04 and 100.05 of part B
0
f. Add section 103.00F of part B.
0
g. Add listing 103.06 of part B.
0
h. Revise section 104.00C2b introductory text of part B.
0
i. Revise section 104.00C2b(ii) of part B.
0
j. Add section 104.00C3 of part B.
0
k. Revise listing 104.02C of part B.
0
l. Revise section 105.00G of part B.
0
m. Revise listing 105.08 of part B.
0
n. Redesignate section 106.00C5 of part B as 106.00C6 and add new 
section 106.00C5.
0
o. Add listing 106.08 of part B.
0
p. Add section 114.00F4d of part B.
0
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 Sec.  
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 Sec.  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).

[[Page 19526]]

    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-for-length 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 Sec.  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 Sec.  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 Sec.  416.926a of this 
chapter) considering the factors in Sec.  416.924a of this chapter. 
We use the rule in Sec.  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 two-thirds 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:

[[Page 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 x Height in Inches)] x 
703
Metric Formulas
    BMI = Weight in Kilograms/(Height in Meters x Height in Meters)
    BMI = [Weight in Kilograms/(Height in Centimeters x Height in 
Centimeters)] x 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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Weight            Length            Weight            Length            Weight
                     Length (centimeters)                          (kilograms)      (centimeters)      (kilograms)      (centimeters)      (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
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 19528]]


                                                     Table II--Females Birth to Attainment of Age 2
                                                     [Third Percentile Values for Weight-for-Length]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Weight            Length            Weight            Length            Weight
                     Length (centimeters)                          (kilograms)      (centimeters)      (kilograms)      (centimeters)      (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                       Age (yrs. and
  Age (yrs. and mos.)          BMI              mos.)              BMI              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              Age (yrs. and
               Age (yrs. and mos.)                   BMI          mos.)         BMI          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

[[Page 19529]]

 
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/mm\3\, 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]

0
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).


0
4. Amend Sec.  416.924b by revising paragraph (b) to read as follows:


Sec.  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

[[Page 19530]]

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.


Sec.  416.926a  [Amended]

0
5. Amend Sec.  416.926a by removing paragraphs (m)(6) and (m)(7) and 
redesignating paragraph (m)(8) as (m)(6).

0
6. Amend Sec.  416.934 by adding paragraphs (j) and (k) to read as 
follows:


Sec.  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



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

                                                  Peoria, IL, General Downing—Peoria                      Minneapolis, MN, Minneapolis-St Paul                  Curtis, NE., Curtis Muni, RNAV (GPS)
                                                    Intl, RNAV (GPS) RWY 4, Amdt 2                          Intl/Wold-Chamberlain, RNAV (RNP)                     RWY 12, Orig
                                                  Peoria, IL, General Downing—Peoria                        Y RWY 12R, Orig                                     Curtis, NE., Curtis Muni, RNAV (GPS)
                                                    Intl, RNAV (GPS) RWY 13, Amdt 1A                      Minneapolis, MN, Minneapolis-St Paul                    RWY 30, Orig
                                                  Peoria, IL, General Downing—Peoria                        Intl/Wold-Chamberlain, RNAV (RNP)                   Curtis, NE., Curtis Muni, Takeoff
                                                    Intl, RNAV (GPS) RWY 22, Amdt 1B                        Y RWY 30L, Orig                                       Minimums and Obstacle DP, Orig
                                                  Peoria, IL, General Downing—Peoria                      New Ulm, MN, New Ulm Muni, NDB                        Oklahoma City, OK, Wiley Post, RNAV
                                                    Intl, RNAV (GPS) RWY 31, Amdt 1B                        RWY 15, Amdt 2A, CANCELED                             (GPS) RWY 17L, Amdt 2A
                                                  Peoria, IL, General Downing—Peoria                      New Ulm, MN, New Ulm Muni, NDB                        Houston, TX, Houston Executive, RNAV
                                                    Intl, Takeoff Minimums and Obstacle                     RWY 33, Amdt 2A, CANCELED                             (GPS) RWY 18, Orig-A
                                                    DP, Amdt 2                                            Steele, MO, Steele Muni, RNAV (GPS)                   Kingsville, TX, Kleberg County, NDB
                                                  Peoria, IL, Mount Hawley Auxiliary,                       RWY 18, Orig                                          RWY 13, Amdt 6, CANCELED
                                                    VOR–A, Amdt 4, CANCELED                               Steele, MO, Steele Muni, RNAV (GPS)                   New Braunfels, TX, New Braunfels
                                                  Peoria, IL, Mount Hawley Auxiliary,                       RWY 36, Orig                                          Rgnl, RNAV (GPS) RWY 13, Amdt 1
                                                    VOR/DME–A, Orig                                       Steele, MO, Steele Muni, Takeoff
                                                                                                                                                                New Braunfels, TX, New Braunfels
                                                  Baton Rouge, LA, Baton Rouge                              Minimums and Obstacle DP, Orig
                                                                                                          Billings, MT, Billings Logan Intl, ILS OR               Rgnl, RNAV (GPS) RWY 31, Amdt 1
                                                    Metropolitan, Ryan Field, ILS OR                                                                            Price, UT, Carbon County Rgnl/Buck
                                                    LOC RWY 13, Amdt 27E                                    LOC/DME RWY 28R, Amdt 2
                                                                                                          Billings, MT, Billings Logan Intl, RNAV                 Davis Field, RNAV (GPS) RWY 1,
                                                  Baton Rouge, LA, Baton Rouge                                                                                    Amdt 2
                                                                                                            (GPS) Y RWY 10L, Amdt 3
                                                    Metropolitan, Ryan Field, ILS OR                      Billings, MT, Billings Logan Intl, RNAV               Siren, WI, Burnett County, RNAV (GPS)
                                                    LOC RWY 22R, Amdt 11B                                   (GPS) Y RWY 28R, Amdt 3                               RWY 5, Orig
                                                  Baton Rouge, LA, Baton Rouge                            Billings, MT, Billings Logan Intl, RNAV               Siren, WI, Burnett County, RNAV (GPS)
                                                    Metropolitan, Ryan Field, NDB RWY                       (RNP) Z RWY 28R, Orig                                 RWY 14, Orig
                                                    31, Amdt 2D                                           Kalispell, MT, Glacier Park Intl, ILS OR              Siren, WI, Burnett County, RNAV (GPS)
                                                  Baton Rouge, LA, Baton Rouge                              LOC RWY 2, Amdt 7                                     RWY 23, Orig
                                                    Metropolitan, Ryan Field, RNAV                        Ahoskie, NC, Tri-County, GPS RWY 1,                   Siren, WI, Burnett County, RNAV (GPS)
                                                    (GPS) RWY 31, Amdt 1D                                   Orig, CANCELED                                        RWY 32, Orig
                                                  Baton Rouge, LA, Baton Rouge                            Ahoskie, NC, Tri-County, GPS RWY 19,                  Siren, WI, Burnett County, VOR RWY 5,
                                                    Metropolitan, Ryan Field, VOR RWY                       Orig, CANCELED                                        Amdt 3
                                                    4L, Amdt 17C                                          Ahoskie, NC, Tri-County, RNAV (GPS)                   [FR Doc. 2015–08113 Filed 4–10–15; 8:45 am]
                                                  Baton Rouge, LA, Baton Rouge                              RWY 1, Orig                                         BILLING CODE 4910–13–P
                                                    Metropolitan, Ryan Field, VOR/DME                     Ahoskie, NC, Tri-County, RNAV (GPS)
                                                    RWY 22R, Amdt 8H                                        RWY 19, Orig
                                                  Gonzales, LA, Louisiana Rgnl, RNAV                      Ahoskie, NC, Tri-County, VOR/DME–A,
                                                                                                                                                                SOCIAL SECURITY ADMINISTRATION
                                                    (GPS) RWY 17, Amdt 1B                                   Amdt 6
                                                  Gonzales, LA, Louisiana Rgnl, VOR/                      Charlotte, NC, Charlotte/Douglas Intl,                20 CFR Parts 404 and 416
                                                    DME–A, Amdt 2A                                          ILS OR LOC RWY 18L, Amdt 8
                                                  Lafayette, LA, Lafayette Rgnl, RNAV                     Charlotte, NC, Charlotte/Douglas Intl,                [Docket No. SSA–2011–0081]
                                                    (GPS) RWY 29, Orig-B                                    ILS OR LOC RWY 18R, ILS RWY 18R                     RIN 0960–AG28
                                                  New Roads, LA, False River Rgnl, LOC                      (SA CAT I), ILS RWY 18R (CAT II),
                                                    RWY 36, Amdt 1A                                         ILS RWY 18R (CAT III), Amdt 1                       Revised Listings for Growth Disorders
                                                  New Roads, LA, False River Rgnl, NDB                    Charlotte, NC, Charlotte/Douglas Intl,                and Weight Loss in Children
                                                    RWY 36, Amdt 2A                                         ILS OR LOC RWY 36L, ILS RWY 36L
                                                  New Roads, LA, False River Rgnl, RNAV                     (SA CAT I), ILS RWY 36L (CAT II),                   AGENCY:    Social Security Administration.
                                                    (GPS) RWY 18, Orig-A                                    ILS RWY 36L (CAT III), Amdt 1                       ACTION:   Final rule.
                                                  New Roads, LA, False River Rgnl, RNAV                   Charlotte, NC, Charlotte/Douglas Intl,
                                                    (GPS) RWY 36, Orig-A                                    ILS OR LOC RWY 36R, ILS RWY 36R                     SUMMARY:    This rule adopts, with one
                                                  New Roads, LA, False River Rgnl, VOR/                     (SA CAT I), ILS RWY 36R (CAT II),                   change, the rule for evaluating growth
                                                    DME–A, Amdt 4A                                          ILS RWY 36R (CAT III), Amdt 12                      disorders in children we proposed in a
                                                  Detroit, MI, Willow Run, Takeoff                        Charlotte, NC, Charlotte/Douglas Intl,                notice of proposed rulemaking (NPRM)
                                                    Minimums and Obstacle DP, Amdt                          RNAV (GPS) Y RWY 18L, Amdt 4                        published in the Federal Register on
                                                    10A                                                   Charlotte, NC, Charlotte/Douglas Intl,                May 22, 2013. Several body systems in
                                                  Minneapolis, MN, Minneapolis-St Paul                      RNAV (GPS) Y RWY 18R, Amdt 1                        the Listing of Impairments (listings)
                                                                                                          Charlotte, NC, Charlotte/Douglas Intl,                contain listings for children based on
                                                    Intl/Wold-Chamberlain, ILS V RWY
                                                                                                            RNAV (GPS) Y RWY 36L, Amdt 1                        impairment of linear growth or weight
                                                    35 (CONVERGING), Amdt 4                               Charlotte, NC, Charlotte/Douglas Intl,
                                                  Minneapolis, MN, Minneapolis-St Paul                                                                          loss. We are replacing those listings
                                                                                                            RNAV (GPS) Y RWY 36R, Amdt 4                        with new listings for low birth weight
                                                    Intl/Wold-Chamberlain, ILS Z OR                       Smithfield, NC, Johnston Regional, ILS
                                                    LOC RWY 35, ILS Z RWY 35 (SA CAT                                                                            (LBW) and failure to thrive; a new
                                                                                                            OR LOC Y RWY 3, Orig                                listing for genitourinary impairments;
                                                    I), ILS Z RWY 35 (CAT II), ILS Z RWY                  Smithfield, NC, Johnston Regional, ILS
                                                    35 (CAT III), Amdt 4                                                                                        and revised listings for growth failure in
                                                                                                            OR LOC Z RWY 3, Amdt 2                              combination with a respiratory,
                                                  Minneapolis, MN, Minneapolis-St Paul                    Smithfield, NC, Johnston Regional, NDB
                                                                                                                                                                cardiovascular, digestive, or immune
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                                                    Intl/Wold-Chamberlain, RNAV (GPS)                       RWY 3, Amdt 2
                                                    Z RWY 30L, Amdt 4                                     Smithfield, NC, Johnston Regional,                    system disorder. These revisions reflect
                                                  Minneapolis, MN, Minneapolis-St Paul                      RNAV (GPS) RWY 3, Amdt 1                            our program experience, advances in
                                                    Intl/Wold-Chamberlain, RNAV (GPS)                     Smithfield, NC, Johnston Regional,                    medical knowledge, and comments we
                                                    Z RWY 35, Amdt 3                                        RNAV (GPS) RWY 21, Amdt 1                           received from medical experts and the
                                                  Minneapolis, MN, Minneapolis-St Paul                    Smithfield, NC, Johnston Regional,                    public.
                                                    Intl/Wold-Chamberlain, RNAV (RNP)                       Takeoff Minimums and Obstacle DP,                   DATES: This rule is effective June 12,
                                                    Y RWY 12L, Orig                                         Amdt 4                                              2015.


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                                                                      Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations                                         19523

                                                  FOR FURTHER INFORMATION CONTACT:                        suggestions for changes in those                      commenter suggested is necessary in
                                                  Cheryl A. Williams, Office of Medical                   provisions. We did not summarize or                   order to apply the rule properly.
                                                  Policy, Social Security Administration,                 respond to those comments.
                                                                                                                                                                Evaluating Infants Born at 33 Weeks
                                                  6401 Security Boulevard, Baltimore,
                                                                                                          Listing 100.04 Low Birth Weight in                    Weighing Less Than 1325 Grams
                                                  Maryland 21235–6401, (410) 965–1020.
                                                                                                          Infants From Birth to Attainment of Age                 Comment: One commenter suggested
                                                  For information on eligibility or filing
                                                  for benefits, call our national toll-free               1                                                     that we add guidance for evaluating
                                                  number, 1–800–772–1213, or TTY 1–                       Low Birth Weight                                      infants who weigh between 1200 grams
                                                  800–325–0778, or visit our Internet site,                                                                     and 1325 grams, and who are born at
                                                  Social Security Online, at http://                         Comment: One commenter suggested                   gestational ages of 32 weeks or less.
                                                  www.socialsecurity.gov.                                 that we provide guidance in the listings                Response: We partially adopted this
                                                                                                          at 100.04A or 100.04B, or in the                      comment. We agree that it is appropriate
                                                  SUPPLEMENTARY INFORMATION:                              introductory text at 100.00, on diaries               to provide guidance for evaluating LBW
                                                  Background                                              used to schedule continuing disability                in infants who are born at 32 weeks
                                                                                                          reviews (CDR) for LBW infants. The                    gestational age. We revised the table in
                                                    We are adopting, as final, the rule for
                                                                                                          commenter believes that, while this                   100.04B to provide a birth weight value
                                                  evaluating growth disorders in children
                                                                                                          guidance is already in our internal                   of 1250 grams or less for the gestational
                                                  we proposed in an NPRM published in
                                                                                                          operating instructions, providing it in               age of 32 weeks. However, we did not
                                                  the Federal Register on May 22, 2013 at
                                                                                                          the regulations would reduce the                      provide birth weight values for
                                                  78 FR 30249. We made one addition to
                                                                                                          number of incorrect diaries being set for             gestational ages less than 32 weeks. The
                                                  this rule as the result of a public
                                                                                                          LBW cases.                                            birth weight values that we would
                                                  comment suggesting we provide
                                                  guidance for evaluating LBW in                             Response: We did not adopt this                    provide for infants born at less than 32
                                                  children born at less than 32 weeks                     comment. In 100.00B, we include a                     weeks would be less than 1200 grams
                                                  gestation or weighing less than 1325                    reference to our rule for CDRs for LBW                and, thus, the birth weight would meet
                                                  grams. We revised the table in listing                  cases at § 416.990(b)(11). Additionally,              the criterion in 100.04A.
                                                  100.04B to include 32 weeks in the                      the Act requires, with one exception,
                                                                                                          that we perform a CDR not later than 12               Listing 100.05 Failure To Thrive in
                                                  Gestational Age column because we
                                                                                                          months after the birth of an infant                   Children From Birth to Attainment of
                                                  believe that this guidance is
                                                                                                          whose LBW is a contributing factor                    Age 3
                                                  appropriate.
                                                    The preamble to the NPRM discussed                    material to the determination that the                Growth Measurements
                                                  the remaining changes from our current                  infant is disabled. We will continue to
                                                                                                                                                                   Comment: One commenter
                                                  rule and our reasons for proposing those                provide guidance on diaries for LBW
                                                                                                                                                                recommended including growth curves
                                                  changes. To the extent that we are                      cases and cases involving other
                                                                                                                                                                in 100.05A to make administrative
                                                  adopting the proposed rule as                           disabling impairments in our internal
                                                                                                                                                                processing for pediatricians easier.
                                                  published, we are not repeating that                    operating instructions. We do not
                                                                                                                                                                Another commenter suggested that we
                                                  information here. Interested readers may                believe it is necessary to repeat this
                                                                                                                                                                make determinations based on growth
                                                  refer to the preamble to the NPRM,                      guidance in the regulation.
                                                                                                                                                                measurements alone without requiring a
                                                  available at http://www.regulations.gov                    Comment: One commenter expressed                   diagnosis of developmental delay.
                                                  under docket number SSA–2011–0081.                      concern that listing 100.04 suggests that                Response: We did not adopt these
                                                  Why are we revising the listings for                    LBW is a disability. The commenter felt               comments. In 100.05A, we require three
                                                  evaluating growth disorders in                          that it should be clear that weight is ‘‘a            weight-for-length measurements or body
                                                  children?                                               proxy measure for prematurity,                        mass index (BMI)-for-age measurements
                                                                                                          dysphagia, and other functional                       that are within a 12-month period, at
                                                    We are revising the listings for                      impairments that are associated with
                                                  evaluating growth disorders in children                                                                       least 60-days apart, and less than the
                                                                                                          disabilities, rather than weight as a                 third percentile on the appropriate table
                                                  to update the medical criteria, provide                 disability itself.’’ The commenter did
                                                  more information on how we evaluate                                                                           in listing 105.08B.2. The adjudicator
                                                                                                          not provide suggested language to                     making the disability determination
                                                  growth disorders, reflect our program                   include in our rule.
                                                  experience, and address adjudicator                                                                           uses the information from growth curves
                                                  questions.                                                 Response: We did not adopt this                    provided by the child’s pediatrician to
                                                                                                          comment. We agree that, for the                       find the corresponding values on the
                                                  Public Comments on the NPRM                             purposes of listing 100.04, weight is a               tables provided. We do not believe it is
                                                     In the NPRM, we provided the public                  proxy measure for disability in infants               necessary to include the growth curves
                                                  with a 60-day comment period, which                     from birth to the attainment of age 1.                in the listing because our adjudicators
                                                  ended on July 22, 2013. We received six                 However, we do not believe that                       use the listing, rather than the
                                                  comments. The commenters included                       providing additional guidance is                      pediatrician who evaluates a child.
                                                  state agencies that make disability                     necessary for the clarity of our rule. As                As we stated in the NPRM, our
                                                  determinations for us, the National                     we noted in the preamble to the                       program experience has shown that
                                                  Association of Disability Examiners,                    proposed rule, we based listing 100.04                growth failure alone is not disabling (78
                                                  medical organizations, such as the                      on sections 416.926a(m)(6) and (m)(7) of              FR at 30251). To meet the severity
                                                  American Academy of Pediatrics, and                     our functional equivalence rule.1 Our                 requirements for listing 100.05B, the
                                                  advocacy groups, such as the Endocrine                  adjudicators have over 20 years of                    child must have growth failure with a
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                                                  Society. We carefully considered all of                 experience evaluating claims filed on                 developmental delay of the appropriate
                                                  the comments, summarized the                            behalf of children based on LBW under                 severity required by the listing. Children
                                                  commenters’ views, and responded to                     our functional equivalence rule. In our               with growth failure without
                                                  all of the significant issues that were                 experience applying this rule, we have                developmental delay may be evaluated
                                                  within the scope of this rule. Some                     not found that the type of guidance the               in the appropriate body system of the
                                                  commenters noted provisions with                                                                              underlying condition causing the
                                                  which they agreed and did not make                        1 78   FR at 30350.                                 growth failure.


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                                                  19524                   Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations

                                                  Developmental Testing                                     functional limitations’’ only if it meets,               medically determinable impairment,
                                                     Comment: One commenter questioned                      medically equals, or functionally equals                 although it can be the result of a
                                                  the requirement for two narrative                         the listings. An impairment is of listing-               medically determinable impairment. We
                                                  developmental reports in 100.05C and                      level severity if it results in ‘‘marked’’               will evaluate children with growth
                                                  the requirement that these two reports                    limitations in two domains of                            failure that does not meet the
                                                  be at least 120 days apart. This                          functioning or an ‘‘extreme’’ limitation                 requirements of listings 100.04 and
                                                  commenter suggested that, if we keep                      in one domain.3 The level of delay that                  100.05 and is associated with a known
                                                  the requirement for two reports, we                       we require in 100.05C is consistent with                 medically determinable impairment
                                                  should require a shorter period of either                 our definition of ‘‘marked limitation’’ in               under the affected body system.
                                                                                                            § 416.926a(e)(2)(ii).                                       Comment: One commenter was
                                                  30 or 60 days between them. Another
                                                                                                               Comment: One commenter expressed
                                                  commenter also expressed concern                                                                                   concerned that, while the majority of
                                                                                                            concern about acceptable timeframes for
                                                  about the requirements for the evidence                                                                            children over the age of 3 with growth
                                                                                                            performing developmental testing in
                                                  of developmental delay. This                                                                                       failure have signs and symptoms of an
                                                                                                            relation to disability determinations
                                                  commenter was concerned about the                                                                                  underlying disorder in the respiratory,
                                                                                                            stated in 100.05B and 100.05C. The
                                                  availability of these records from                                                                                 cardiovascular, digestive, genitourinary,
                                                                                                            commenter suggested that the testing to
                                                  providers.                                                                                                         or immune body system, some children
                                                                                                            establish the child’s current level of
                                                     Response: We did not adopt these                                                                                over the age of 3 will not. This
                                                                                                            development be performed within 6
                                                  comments. In 100.05C, we require two                                                                               commenter suggested that we include
                                                                                                            months of adjudication.
                                                  narrative developmental reports when a                       Response: We partially adopted this                   exceptions for conditions, such as
                                                  report of a standardized developmental                    comment. We agree that evidence about                    Turner syndrome (female
                                                  assessment required by 100.05B is not                     a child’s development must be recent                     hypogonadism) and acquired growth
                                                  available. As we explained in the                         and current in relation to a disability                  hormone deficiency, where growth
                                                  NPRM, abnormal findings noted on                          determination, and we have revised                       failure may be a significant component
                                                  repeated examinations, and information                    listings 100.05B and 100.05C2 to clarify                 of the disease process.
                                                  in narrative developmental reports, that                  this requirement. However, the facts in                     Response: We did not adopt this
                                                  may include the results of                                a specific case determine whether the                    comment. After a child attains age 3, we
                                                  developmental screening tests, can                        evidence is current. Determining factors                 will evaluate his or her impairment
                                                  identify a child who is not developing                    include, but are not limited to, the age                 under the affected body system. The two
                                                  or achieving skills within expected                       of the child, the amount of delay, and                   examples provided by the commenter
                                                  timeframes.2                                              the developmental trajectory                             are endocrine disorders. Although these
                                                     We do not believe that 30 or 60 days                   documented over time. We are not                         two disorders are not listed impairments
                                                  is enough time for these kinds of                         setting specific timeframes for when                     for children, they may rise to listing-
                                                  changes to appear on testing. We believe                  developmental testing must be                            level severity because of their effects in
                                                  that 120 days is an appropriate period                    performed, but we are specifying that                    other body systems. As the commenter
                                                  for developmental testing to be                           the evidence must reflect the child’s                    explained, children with Turner
                                                  performed and to allow for any changes                    current development.                                     syndrome may experience
                                                  in development to show on testing.                                                                                 complications, such as heart disease, to
                                                     While we understand the                                Linear Growth
                                                                                                                                                                     a degree that is disabling. We would
                                                  commenter’s concern about the                                Comment: One commenter agreed                         evaluate the complications under the
                                                  availability of evidence, we believe that,                with our use of weight-for-length and                    affected body system.
                                                  for the children whose impairments we                     BMI-for-age charts to evaluate growth
                                                  evaluate under listing 100.05, evidence                   failure, rather than of linear (height or                Listing 103.06 Growth Failure Due to
                                                  generally will be available from                          length) growth charts. The commenter                     Any Chronic Respiratory Disorder
                                                  providers because these children are                      expressed concern, however, that an                         Comment: Two commenters were
                                                  likely to be identified, and subsequently                 underlying condition could cause a                       concerned with the requirement for
                                                  treated because of their identification,                  child to have such profound growth                       oxygen supplementation in 103.06A.
                                                  by early intervention programs.                           failure that BMI for the child’s age                     The commenters noted that some
                                                     Comment: One commenter noted that                      would become normal, despite his or                      respiratory disorders, such as asthma,
                                                  most early intervention programs use ‘‘a                  her significant growth failure.                          bronchiectasis, and cystic fibrosis, could
                                                  25 percent delay criteria as opposed to                      Response: We did not adopt this
                                                                                                                                                                     result in listing-level growth failure
                                                  the two-thirds criteria’’ required in                     comment. We understand the
                                                                                                                                                                     without requiring oxygen
                                                  100.05C. However, the commenter did                       commenter’s concerns that some
                                                                                                                                                                     supplementation.
                                                  not provide any suggestions for                           children may have underlying
                                                  changing the criterion.                                   conditions that cause linear growth                         Response: We did not adopt these
                                                     Response: We did not adopt this                        impairments while their BMI-for-age                      comments. We agree with the
                                                  comment. We recognize that early                          measurements are normal. After                           commenters that some respiratory
                                                  intervention programs often use a 25                      attainment of age 2, most children                       disorders could result in listing-level
                                                  percent delay criterion to determine                      without an underlying medical disorder                   growth failure without requiring oxygen
                                                  eligibility for intervention services and                 follow a growth trajectory that remains                  supplementation; however, we did not
                                                  to identify the needed services. In                       fairly constant during childhood.                        revise 103.06 as a result. We use other
                                                                                                                                                                     listings, such as 103.02, 103.03, and
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                                                  contrast, we evaluate a child’s delay to                     Our adjudicative experience has
                                                  determine whether the underlying                          shown that a declining linear growth                     103.04, in the respiratory body system
                                                  impairment is disabling because it                        rate is not always indicative of a                       to evaluate these disorders.4 We believe
                                                  results in ‘‘marked and severe                            disabling condition. Short stature,                      that these respiratory listings, and our
                                                  functional limitations.’’ An impairment                   length, or height below the third                        functional equivalence rule for
                                                  results in ‘‘marked and severe                            percentile, in and of itself, is not a                   evaluating disability in children,

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



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                                                                        Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations                                              19525

                                                  adequately address the disorders                           approval under the Paperwork                        ■ n. Redesignate section 106.00C5 of
                                                  referred to by the commenters.5                            Reduction Act.                                      part B as 106.00C6 and add new section
                                                                                                             (Catalog of Federal Domestic Assistance             106.00C5.
                                                  What is our authority to make rules
                                                  and set procedures for determining                         Program Nos. 96.001, Social Security—               ■ o. Add listing 106.08 of part B.
                                                                                                             Disability Insurance; 96.002, Social                ■ p. Add section 114.00F4d of part B.
                                                  whether a person is disabled under the
                                                                                                             Security—Retirement Insurance; 96.004,
                                                  statutory definition?                                      Social Security—Survivors Insurance; and            ■ q. Revise listing 114.08H of part B.
                                                    The Act authorizes us to make rules                      96.006, Supplemental Security Income).                The revisions and additions read as
                                                  and regulations and to establish                                                                               follows:
                                                                                                             List of Subjects
                                                  necessary and appropriate procedures to                                                                        APPENDIX 1 TO SUBPART P OF PART
                                                  implement them.6                                           20 CFR Part 404
                                                                                                                                                                 404—LISTING OF IMPAIRMENTS
                                                  When will we use this final rule?                            Administrative practice and
                                                                                                                                                                 *        *   *      *     *
                                                                                                             procedure; Blind, Disability benefits;                1. Low Birth Weight and Failure to Thrive
                                                     We will begin to use this final rule on                 Old-Age, Survivors, and Disability                  (100.00): June 12, 2020.
                                                  its effective date. We will continue to                    Insurance; Reporting and recordkeeping
                                                  use the current listings until the date                                                                        *        *   *      *     *
                                                                                                             requirements; Social Security.                          Part B
                                                  this final rule becomes effective. We
                                                  will apply the final rule to new                           20 CFR Part 416                                     *        *   *      *     *
                                                  applications filed on or after the                           Administrative practice and                         100.00 Low Birth Weight and Failure to
                                                  effective date of the final rule and to                                                                        Thrive.
                                                                                                             procedure; Aged, Blind, Disability
                                                  claims that are pending on or after the                    benefits; Public assistance programs;               *        *   *      *     *
                                                  effective date.7                                           Reporting and recordkeeping                         100.00 LOW BIRTH WEIGHT AND
                                                                                                             requirements; Supplemental Security                 FAILURE TO THRIVE
                                                  How long will this final rule be
                                                  effective?                                                 Income (SSI).                                          A. What conditions do we evaluate under
                                                                                                                                                                 these listings? We evaluate low birth weight
                                                     This final rule will remain in effect                   Carolyn W. Colvin,                                  (LBW) in infants from birth to attainment of
                                                  for 5 years after the date it becomes                      Acting Commissioner of Social Security.             age 1 and failure to thrive (FTT) in infants
                                                  effective, unless we extend it or revise                     For the reasons set out in the                    and toddlers from birth to attainment of age
                                                  and issue it again.                                        preamble, we are amending 20 CFR part               3.
                                                                                                                                                                    B. How do we evaluate disability based on
                                                  Regulatory Procedures                                      404 subpart P and part 416 subpart I as             LBW under 100.04? In 100.04A and 100.04B,
                                                                                                             set forth below:                                    we use an infant’s birth weight as
                                                  Executive Order 12866, as                                                                                      documented by an original or certified copy
                                                  Supplemented by Executive Order                            PART 404—FEDERAL OLD-AGE,                           of the infant’s birth certificate or by a medical
                                                  13563                                                      SURVIVORS AND DISABILITY                            record signed by a physician. Birth weight
                                                                                                             INSURANCE (1950–)                                   means the first weight recorded after birth. In
                                                     We consulted with the Office of                                                                             100.04B, gestational age is the infant’s age
                                                  Management and Budget (OMB) and                            ■ 1. The authority citation for subpart P           based on the date of conception as recorded
                                                  determined that this final rule meets the                  of part 404 continues to read as follows:           in the medical record. If the infant’s
                                                  criteria for a significant regulatory                                                                          impairment meets the requirements for
                                                                                                               Authority: Secs. 202, 205(a)–(b) and (d)–
                                                  action under Executive Order 12866, as                     (h), 216(i), 221(a), (i), and (j), 222(c), 223,     listing 100.04A or 100.04B, we will follow
                                                  supplemented by Executive Order                            225, and 702(a)(5) of the Social Security Act       the rule in § 416.990(b)(11) of this chapter.
                                                  13563. Therefore, OMB reviewed this                        (42 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i),        C. How do we evaluate disability based on
                                                  final rule.                                                421(a), (i), and (j), 422(c), 423, 425, and         FTT under 100.05?
                                                                                                             902(a)(5)); sec. 211(b), Pub. L. 104–193, 110          1. General. We establish FTT with or
                                                  Regulatory Flexibility Act                                 Stat. 2105, 2189; sec. 202, Pub. L. 108–203,        without a known cause when we have
                                                                                                             118 Stat. 509 (42 U.S.C. 902 note).                 documentation of an infant’s or a toddler’s
                                                    We certify that this final rule would                                                                        growth failure and developmental delay from
                                                  not have a significant economic impact                     ■ 2. Amend appendix 1 to subpart P of               an acceptable medical source(s) as defined in
                                                  on a substantial number of small entities                  part 404 as follows:                                § 416.913(a) of this chapter. We require
                                                  because they affect individuals only.                      ■ a. Revise item 1 of the introductory              documentation of growth measurements in
                                                  Therefore, a regulatory flexibility                        text before part A of appendix 1.                   100.05A and developmental delay described
                                                  analysis is not required under the                                                                             in 100.05B or 100.05C within the same
                                                                                                             ■ b. Amend part B by revising the body
                                                  Regulatory Flexibility Act, as amended.                                                                        consecutive 12-month period. The dates of
                                                                                                             system name for section 100.00 in the               developmental testing and reports may be
                                                  Paperwork Reduction Act                                    table of contents.                                  different from the dates of growth
                                                                                                             ■ c. Revise sections 100.00 and 100.01              measurements. After the attainment of age 3,
                                                    This final rule does not create any                      of part B.                                          we evaluate growth failure under the affected
                                                  new or affect any existing collections                     ■ d. Remove sections 100.02 and 100.03              body system(s).
                                                  and, therefore, does not require OMB                       of part B.                                             2. Growth failure. Under 100.05A, we use
                                                                                                             ■ e. Add sections 100.04 and 100.05 of              the appropriate table(s) under 105.08B in the
                                                    5 See  20 CFR 416.924a and 416.926a.                     part B                                              digestive system to determine whether a
                                                    6 42 U.S.C. 405(a), 902(a)(5), and 1383(d)(1).           ■ f. Add section 103.00F of part B.                 child’s growth is less than the third
                                                     7 This means that we will use this final rule on
                                                                                                             ■ g. Add listing 103.06 of part B.                  percentile. The child does not need to have
                                                  and after its effective date in any case in which we                                                           a digestive disorder for purposes of 100.05.
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                                                                                                             ■ h. Revise section 104.00C2b
                                                  make a determination or decision. We expect that                                                                  a. For children from birth to attainment of
                                                  Federal courts will review our final decisions using       introductory text of part B.                        age 2, we use the weight-for-length table
                                                  the rule that was in effect at the time we issued the      ■ i. Revise section 104.00C2b(ii) of part
                                                                                                                                                                 corresponding to the child’s gender (Table I
                                                  decisions. If a court reverses our final decision and      B.
                                                  remands a case for further administrative
                                                                                                                                                                 or Table II).
                                                                                                             ■ j. Add section 104.00C3 of part B.                   b. For children age 2 to attainment of age
                                                  proceedings after the effective date of this final rule,
                                                  we will apply this final rule to the entire period at      ■ k. Revise listing 104.02C of part B.              3, we use the body mass index (BMI)-for-age
                                                  issue in the decision we make after the court’s            ■ l. Revise section 105.00G of part B.              table corresponding to the child’s gender
                                                  remand.                                                    ■ m. Revise listing 105.08 of part B.               (Table III or Table IV).



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                                                  19526               Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations

                                                     c. BMI is the ratio of a child’s weight to the       greater than 1200 grams but less than 2000                AND
                                                  square of his or her height. We calculate BMI           grams and their weight and gestational age do               B. Developmental delay (see 100.00C1 and
                                                  using the formulas in 105.00G2c.                        not meet listing 100.04. The most common                  C3), established by an acceptable medical
                                                     d. Growth measurements. The weight-for-              disorders of prematurity and LBW include                  source and documented by findings from one
                                                  length measurements for children from birth             retinopathy of prematurity (ROP), chronic                 current report of a standardized
                                                  to the attainment of age 2 and BMI-for-age              lung disease of infancy (CLD, previously                  developmental assessment (see 100.00C3b)
                                                  measurements for children age 2 to                      known as bronchopulmonary dysplasia, or                   that:
                                                  attainment of age 3 that are required for this          BPD), intraventricular hemorrhage (IVH),
                                                                                                                                                                      1. Shows development not more than two-
                                                  listing must be obtained within a 12-month              necrotizing enterocolitis (NEC), and
                                                                                                                                                                    thirds of the level typically expected for the
                                                  period and at least 60 days apart. If a child           periventricular leukomalacia (PVL). Other
                                                                                                                                                                    child’s age; or
                                                  attains age 2 during the evaluation period,             disorders include poor nutrition and growth
                                                  additional measurements are not needed.                 failure, hearing disorders, seizure disorders,              2. Results in a valid score that is at least
                                                  Any measurements taken before the child                 cerebral palsy, and developmental disorders.              two standard deviations below the mean.
                                                  attains age 2 can be used to evaluate the               We evaluate these disorders under the                     OR
                                                  impairment under the appropriate listing for            affected body systems.                                      C. Developmental delay (see 100.00C3),
                                                  the child’s age. If the child attains age 3                2. We may evaluate infants and toddlers                established by an acceptable medical source
                                                  during the evaluation period, the                       with growth failure that is associated with a             and documented by findings from two
                                                  measurements can be used to evaluate the                known medical disorder under the body                     narrative developmental reports (see
                                                  impairment in the affected body system.                 system of that medical disorder, for example,             100.00C3c) that:
                                                     3. Developmental delay.                              the respiratory or digestive body systems.                  1. Are dated at least 120 days apart (see
                                                     a. Under 100.05B and C, we use reports                  3. If an infant or toddler has a severe                100.00C1); and
                                                  from acceptable medical sources to establish            medically determinable impairment(s) that                   2. Indicate current development not more
                                                  delay in a child’s development.                         does not meet the criteria of any listing, we             than two-thirds of the level typically
                                                     b. Under 100.05B, we document the                    must also consider whether the child has an               expected for the child’s age.
                                                  severity of developmental delay with results            impairment(s) that medically equals a listing
                                                  from a standardized developmental                       (see § 416.926 of this chapter). If the child’s           *        *     *    *     *
                                                  assessment, which compares a child’s level              impairment(s) does not meet or medically                  103.00       RESPIRATORY SYSTEM
                                                  of development to the level typically                   equal a listing, we will determine whether
                                                  expected for his or her chronological age. If           the child’s impairment(s) functionally equals             *        *     *    *     *
                                                  the child was born prematurely, we may use              the listings (see § 416.926a of this chapter)                F. How do we evaluate growth failure due
                                                  the corrected chronological age (CCA) for               considering the factors in § 416.924a of this             to any chronic respiratory disorder?
                                                  comparison. (See § 416.924b(b) of this                  chapter. We use the rule in § 416.994a of this               1. To evaluate growth failure due to any
                                                  chapter.) CCA is the chronological age                  chapter when we decide whether a child                    chronic respiratory disorder, we require
                                                  adjusted by a period of gestational                     continues to be disabled.                                 documentation of the oxygen
                                                  prematurity. CCA = (chronological age)—                                                                           supplementation described in 103.06A and
                                                                                                          100.01 Category of Impairments, Low Birth                 the growth measurements in 103.06B within
                                                  (number of weeks premature). Acceptable                 Weight and Failure to Thrive
                                                  medical sources or early intervention                                                                             the same consecutive 12-month period. The
                                                  specialists, physical or occupational                      100.04 Low birth weight in infants from                dates of oxygen supplementation may be
                                                  therapists, and other sources may conduct               birth to attainment of age 1.                             different from the dates of growth
                                                  standardized developmental assessments and                 A. Birth weight (see 100.00B) of less than             measurements.
                                                  developmental screenings. The results of                1200 grams.                                                  2. Under 103.06B, we use the appropriate
                                                  these tests and screenings must be                      OR                                                        table(s) under 105.08B in the digestive
                                                  accompanied by a statement or records from                 B. The following gestational age and birth             system to determine whether a child’s growth
                                                  an acceptable medical source who                        weight:                                                   is less than the third percentile.
                                                  established the child has a developmental                                                                            a. For children from birth to attainment of
                                                  delay.                                                   Gestational                                              age 2, we use the weight-for-length table
                                                     c. Under 100.05C, when there are no                       age                         Birth weight             corresponding to the child’s gender (Table I
                                                  results from a standardized developmental                (in weeks)                                               or Table II).
                                                  assessment in the case record, we need                                                                               b. For children age 2 to attainment of age
                                                  narrative developmental reports from the                37–40 ..........      2000   grams   or   less.           18, we use the body mass index (BMI)-for-age
                                                  child’s medical sources in sufficient detail to         36 ................   1875   grams   or   less.           table corresponding to the child’s gender
                                                  assess the severity of his or her                       35 ................   1700   grams   or   less.           (Table III or Table IV).
                                                  developmental delay. A narrative                        34 ................   1500   grams   or   less.              c. BMI is the ratio of a child’s weight to the
                                                  developmental report is based on clinical               33 ................   1325   grams   or   less.           square of his or her height. We calculate BMI
                                                  observations, progress notes, and well-baby             32 ................   1250   grams   or   less.           using the formulas in 105.00G2c.
                                                  check-ups. To meet the requirements for                                                                           *        *     *    *     *
                                                  100.05C, the report must include: The child’s              100.05 Failure to thrive in children from                103.06 Growth failure due to any chronic
                                                  developmental history; examination findings             birth to attainment of age 3 (see 100.00C),               respiratory disorder (see 103.00F),
                                                  (with abnormal findings noted on repeated               documented by A and B, or A and C.                        documented by:
                                                  examinations); and an overall assessment of                A. Growth failure as required in 1 or 2:                 A. Hypoxemia with the need for at least 1.0
                                                  the child’s development (that is, more than                1. For children from birth to attainment of            L/min of oxygen supplementation for at least
                                                  one or two isolated skills) by the medical              age 2, three weight-for-length measurements               4 hours per day and for at least 90
                                                  source. Some narrative developmental                    that are:
                                                                                                                                                                    consecutive days.
                                                  reports may include results from                           a. Within a consecutive 12-month period;
                                                  developmental screening tests, which can                and                                                       AND
                                                  identify a child who is not developing or                  b. At least 60 days apart; and                           B. Growth failure as required in 1 or 2:
                                                  achieving skills within expected timeframes.               c. Less than the third percentile on the                 1. For children from birth to attainment of
                                                  Although medical sources may refer to                   appropriate weight-for-length table in listing            age 2, three weight-for-length measurements
                                                  screening test results as supporting evidence           105.08B1; or                                              that are:
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                                                  in the narrative developmental report,                     2. For children age 2 to attainment of age               a. Within a consecutive 12-month period;
                                                  screening test results alone cannot establish           3, three BMI-for-age measurements that are:               and
                                                  a diagnosis or the severity of developmental               a. Within a consecutive 12-month period;                 b. At least 60 days apart; and
                                                  delay.                                                  and                                                         c. Less than the third percentile on the
                                                     D. How do we evaluate disorders that do                 b. At least 60 days apart; and                         appropriate weight-for-length table under
                                                  not meet one of these listings?                            c. Less than the third percentile on the               105.08B1; or
                                                     1. We may find infants disabled due to               appropriate BMI-for-age table in listing                    2. For children age 2 to attainment of age
                                                  other disorders when their birth weights are            105.08B2.                                                 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;                                    (i) For children from birth to attainment of          be different from the dates of growth
                                                  and                                                                         age 2, we use the weight-for-length table               measurements.
                                                    b. At least 60 days apart; and                                            corresponding to the child’s gender (Table I              2. Under 105.08B, we evaluate a child’s
                                                    c. Less than the third percentile on the                                  or Table II).                                           growth failure by using the appropriate table
                                                  appropriate BMI-for-age table under                                           (ii) For children age 2 to attainment of age          for age and gender.
                                                  105.08B2.                                                                   18, we use the body mass index (BMI)-for-age              a. For children from birth to attainment of
                                                  *       *         *         *          *                                    table corresponding to the child’s gender               age 2, we use the weight-for-length table (see
                                                                                                                              (Table III or Table IV).                                Table I or Table II).
                                                  104.00      CARDIOVASCULAR SYSTEM                                             (iii) BMI is the ratio of a child’s weight to
                                                                                                                                                                                        b. For children age 2 to attainment of age
                                                  *       *         *         *          *                                    the square of his or her height. We calculate
                                                                                                                                                                                      18, we use the body mass index (BMI)-for-age
                                                      C. Evaluating Chronic Heart Failure                                     BMI using the formulas in 105.00G2c.
                                                                                                                                                                                      table (see Tables III or IV).
                                                  *       *         *         *          *                                    *      *      *       *      *                            c. BMI is the ratio of a child’s weight to the
                                                      2. What evidence of CHF do we need?                                     104.02 * * *                                            square of the child’s height. We calculate
                                                  *       *         *         *          *                                    *      *      *       *      *                          BMI using one of the following formulas:
                                                     b. To establish that you have chronic heart                                C. Growth failure as required in 1 or 2:              English Formula
                                                  failure, we require that your medical history                                 1. For children from birth to attainment of             BMI = [Weight in Pounds/(Height in Inches
                                                  and physical examination describe                                           age 2, three weight-for-length measurements                  × Height in Inches)] × 703
                                                  characteristic symptoms and signs of                                        that are:                                               Metric Formulas
                                                  pulmonary or systemic congestion or of                                        a. Within a consecutive 12-month period;                BMI = Weight in Kilograms/(Height in
                                                  limited cardiac output associated with                                      and                                                          Meters × Height in Meters)
                                                  abnormal findings on appropriate medically                                    b. At least 60 days apart; and                          BMI = [Weight in Kilograms/(Height in
                                                  acceptable imaging. When a remediable                                         c. Less than the third percentile on the                   Centimeters × Height in Centimeters)] ×
                                                  factor, such as arrhythmia, triggers an acute                               appropriate weight-for-length table under                    10,000
                                                  episode of heart failure, you may experience                                105.08B1; or
                                                  restored cardiac function, and a chronic                                      2. For children age 2 to attainment of age            *       *    *     *        *
                                                  impairment may not be present.                                              18, three BMI-for-age measurements that are:               105.08 Growth failure due to any
                                                                                                                                a. Within a consecutive 12-month period;              digestive disorder (see 105.00G), documented
                                                  *       *         *         *          *
                                                                                                                              and                                                     by A and B:
                                                    (ii) During infancy, other manifestations of
                                                  chronic heart failure may include repeated                                    b. At least 60 days apart; and                           A. Chronic nutritional deficiency present
                                                                                                                                c. Less than the third percentile on the              on at least two evaluations at least 60 days
                                                  lower respiratory tract infections.
                                                                                                                              appropriate BMI-for-age table under                     apart within a consecutive 12-month period
                                                  *       *         *         *          *                                    105.08B2.                                               documented by one of the following:
                                                     3. How do we evaluate growth failure due                                                                                            1. Anemia with hemoglobin less than 10.0
                                                                                                                              *      *      *       *      *
                                                  to CHF?                                                                                                                             g/dL; or
                                                     a. To evaluate growth failure due to CHF,                                105.00     DIGESTIVE SYSTEM
                                                                                                                                                                                         2. Serum albumin of 3.0 g/dL or less;
                                                  we require documentation of the clinical                                    *      *      *       *      *
                                                  findings of CHF described in 104.00C2 and                                                                                           AND
                                                                                                                                G. How do we evaluate growth failure due
                                                  the growth measurements in 104.02C within                                   to any digestive disorder?                                 B. Growth failure as required in 1 or 2:
                                                  the same consecutive 12-month period. The                                     1. To evaluate growth failure due to any                 1. For children from birth to attainment of
                                                  dates of clinical findings may be different                                 digestive disorder, we require documentation            age 2, three weight-for-length measurements
                                                  from the dates of growth measurements.                                      of the laboratory findings of chronic                   that are:
                                                     b. Under 104.02C, we use the appropriate                                 nutritional deficiency described in 105.08A                a. Within a 12-month period; and
                                                  table(s) under 105.08B in the digestive                                     and the growth measurements in 105.08B                     b. At least 60 days apart; and
                                                  system to determine whether a child’s growth                                within the same consecutive 12-month                       c. Less than the third percentile on Table
                                                  is less than the third percentile.                                          period. The dates of laboratory findings may            I or Table II; or

                                                                                                                     TABLE I—MALES BIRTH TO ATTAINMENT OF AGE 2
                                                                                                                              [Third Percentile Values for Weight-for-Length]

                                                                              Length                                                Weight                 Length                Weight              Length              Weight
                                                                           (centimeters)                                          (kilograms)           (centimeters)          (kilograms)        (centimeters)        (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
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                                                  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                                                Weight                      Length                  Weight                Length                Weight
                                                                            (centimeters)                                          (kilograms)                (centimeters)            (kilograms)          (centimeters)          (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                                     a. Within a consecutive 12-month period;                      c. Less than the third percentile on Table
                                                  18, three BMI-for-age measurements that are:                                   and                                                          III or Table IV.
                                                                                                                                   b. At least 60 days apart; and

                                                                                                                   TABLE III—MALES AGE 2 TO ATTAINMENT OF AGE 18
                                                                                                                                    [Third Percentile Values for BMI-for-Age]

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

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

                                                  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
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                                                  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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                                                                              Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations                                                                         19529

                                                                                                  TABLE IV—FEMALES AGE 2 TO ATTAINMENT OF AGE 18—Continued
                                                                                                                                  [Third Percentile Values for BMI-for-Age]

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

                                                  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



                                                  *        *         *         *        *                                    114.00        IMMUNE SYSTEM DISORDERS                               a. Within a consecutive 12-month period;
                                                  106.00       GENITOURINARY IMPAIRMENTS                                     *         *         *         *        *                          and
                                                                                                                                 F. * * *                                                        b. At least 60 days apart; and
                                                  *        *         *         *        *                                                                                                        c. Less than the third percentile on the
                                                   C. What other factors do we consider when                                 *         *         *         *        *                          appropriate BMI-for-age table under
                                                  we evaluate your genitourinary disorder?                                     4. HIV infection manifestations specific to                     105.08B2.
                                                                                                                             children.
                                                  *        *         *         *        *                                                                                                      *       *    *      *       *
                                                     5. Growth failure due to any chronic renal                              *         *         *         *        *
                                                  disease.                                                                     d. Growth failure due to HIV immune
                                                                                                                             suppression.
                                                                                                                                                                                               PART 416—SUPPLEMENTAL
                                                     a. To evaluate growth failure due to any                                                                                                  SECURITY INCOME FOR THE AGED,
                                                  chronic renal disease, we require                                            (i) To evaluate growth failure due to HIV
                                                  documentation of the laboratory findings                                   immune suppression, we require                                    BLIND, AND DISABLED
                                                  described in 106.08A and the growth                                        documentation of the laboratory values
                                                  measurements in 106.08B within the same                                    described in 114.08H1 and the growth                              Subpart I—[Amended]
                                                  consecutive 12-month period. The dates of                                  measurements in 114.08H2 or 114.08H3
                                                  laboratory findings may be different from the                              within the same consecutive 12-month                              ■ 3. The authority citation for subpart I
                                                  dates of growth measurements.                                              period. The dates of laboratory findings may                      of part 416 continues to read as follows:
                                                     b. Under 106.08B, we use the appropriate                                be different from the dates of growth
                                                                                                                                                                                                 Authority: Secs. 221(m), 702(a)(5), 1611,
                                                  table(s) under 105.08B in the digestive                                    measurements.
                                                                                                                                                                                               1614, 1619, 1631(a), (c), (d)(1), and (p), and
                                                  system to determine whether a child’s growth                                 (ii) Under 114.08H2 and 114.08H3, we use
                                                                                                                                                                                               1633 of the Social Security Act (42 U.S.C.
                                                  is less than the third percentile.                                         the appropriate table under 105.08B in the
                                                                                                                                                                                               421(m), 902(a)(5), 1382, 1382c, 1382h,
                                                     (i) For children from birth to attainment of                            digestive system to determine whether a
                                                                                                                             child’s growth is less than the third                             1383(a), (c), (d)(1), and (p), and 1383b); secs.
                                                  age 2, we use the weight-for-length table                                                                                                    4(c) and 5, 6(c)–(e), 14(a), and 15, Pub. L. 98–
                                                  corresponding to the child’s gender (Table I                               percentile.
                                                                                                                               (A) For children from birth to attainment                       460, 98 Stat. 1794, 1801, 1802, and 1808 (42
                                                  or Table II).                                                                                                                                U.S.C. 421 note, 423 note, and 1382h note).
                                                     (ii) For children age 2 to attainment of age                            of age 2, we use the weight-for-length table
                                                  18, we use the body mass index (BMI)-for-age                               corresponding to the child’s gender (Table I                      ■ 4. Amend § 416.924b by revising
                                                  table corresponding to the child’s gender                                  or Table II).
                                                                                                                               (B) For children age 2 to attainment of age                     paragraph (b) to read as follows:
                                                  (Table III or Table IV).
                                                     (iii) BMI is the ratio of a child’s weight to                           18, we use the body mass index (BMI)-for-age                      § 416.924b Age as a factor of evaluation in
                                                  the square of his or her height. We calculate                              table corresponding to the child’s gender                         the sequential evaluation process for
                                                  BMI using the formulas in 105.00G2c.                                       (Table III or Table IV).                                          children.
                                                                                                                               (C) BMI is the ratio of a child’s weight to
                                                  *        *         *         *        *                                    the square of his or her height. We calculate                     *      *    *     *    *
                                                    106.08 Growth failure due to any chronic                                 BMI using the formulas in 105.00G2c.                                 (b) Correcting chronological age of
                                                  renal disease (see 106.00C5), with:                                                                                                          premature infants. We generally use
                                                    A. Serum creatinine of 2 mg/dL or greater,
                                                                                                                             *         *         *         *        *
                                                                                                                             114.08 * * *
                                                                                                                                                                                               chronological age (a child’s age based on
                                                  documented at least two times within a
                                                                                                                                                                                               birth date) when we decide whether, or
                                                  consecutive 12-month period with at least 60                               *         *         *         *        *
                                                  days between measurements.                                                                                                                   the extent to which, a physical or
                                                                                                                                H. Immune suppression and growth failure
                                                  AND                                                                        (see 114.00F4d) documented by 1 and 2, or                         mental impairment or combination of
                                                                                                                             by 1 and 3.                                                       impairments causes functional
                                                    B. Growth failure as required in 1 or 2:
                                                    1. For children from birth to attainment of                                 1. CD4 measurement:                                            limitations. However, if you were born
                                                  age 2, three weight-for-length measurements                                   a. For children from birth to attainment of                    prematurely, we may consider you
                                                  that are:                                                                  age 5, CD4 percentage of less than 20 percent;                    younger than your chronological age
                                                    a. Within a consecutive 12-month period;                                 or                                                                when we evaluate your development.
                                                  and                                                                           b. For children age 5 to attainment of age                     We may use a ‘‘corrected’’ chronological
                                                    b. At least 60 days apart; and                                           18, absolute CD4 count of less than 200 cells/
                                                                                                                             mm3, or CD4 percentage of less than 14
                                                                                                                                                                                               age (CCA); that is, your chronological
                                                    c. Less than the third percentile on the                                                                                                   age adjusted by a period of gestational
                                                                                                                             percent; and
                                                  appropriate weight-for-length table under                                                                                                    prematurity. We consider an infant born
                                                                                                                                2. For children from birth to attainment of
                                                  105.08B1; or
                                                                                                                             age 2, three weight-for-length measurements                       at less than 37 weeks’ gestation to be
                                                    2. For children age 2 to attainment of age
                                                                                                                             that are:                                                         born prematurely.
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                                                  18, three BMI-for-age measurements that are:
                                                                                                                                a. Within a consecutive 12-month period;                          (1) We compute your CCA by
                                                    a. Within a consecutive 12-month period;                                 and
                                                  and                                                                                                                                          subtracting the number of weeks of
                                                                                                                                b. At least 60 days apart; and
                                                    b. At least 60 days apart; and                                              c. Less than the third percentile on the
                                                                                                                                                                                               prematurity (the difference between 40
                                                    c. Less than the third percentile on the                                 appropriate weight-for-length table under                         weeks of full-term gestation and the
                                                  appropriate BMI-for-age table under                                        105.08B1; or                                                      number of actual weeks of gestation)
                                                  105.08B2.                                                                     3. For children age 2 to attainment of age                     from your chronological age. For
                                                  *        *         *         *        *                                    18, three BMI-for-age measurements that are:                      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                      DEPARTMENT OF HEALTH AND                              FOR FURTHER INFORMATION CONTACT:
                                                  gestation (8 weeks premature), then                      HUMAN SERVICES                                        Scott Gonzalez, Center for Devices and
                                                  your CCA is 12 weeks.                                                                                          Radiological Health, Food and Drug
                                                                                                           Food and Drug Administration                          Administration, 10903 New Hampshire
                                                     (2) We evaluate developmental delay
                                                  in a premature child until the child’s                                                                         Ave., Bldg. 66, Rm. 4641, Silver Spring,
                                                                                                           21 CFR Part 1020                                      MD 20993–0002, 301–796–5889.
                                                  prematurity is no longer a relevant
                                                  factor, generally no later than about                    [Docket No. FDA–2015–N–0828]                          SUPPLEMENTARY INFORMATION:
                                                  chronological age 2.                                                                                           I. What is the background of this Rule?
                                                                                                           Performance Standards for Ionizing
                                                     (i) If you have not attained age 1 and                                                                         FDA is correcting a drafting error
                                                                                                           Radiation Emitting Products;
                                                  were born prematurely, we will assess                    Fluoroscopic Equipment; Correction                    regarding fluoroscopic equipment
                                                  your development using your CCA.                                                                               measurement in § 1020.32 (21 CFR
                                                     (ii) If you are over age 1 and have a                 AGENCY:    Food and Drug Administration,              1020.32). We are publishing this direct
                                                  developmental delay, and prematurity is                  HHS.                                                  final rule because it is intended to make
                                                  still a relevant factor, we will decide                  ACTION:   Direct final rule.                          a noncontroversial amendment to
                                                  whether to correct your chronological                                                                          § 1020.32, and we do not anticipate any
                                                                                                           SUMMARY:   The Food and Drug                          significant adverse comments.
                                                  age. We will base our decision on our
                                                                                                           Administration (FDA) is amending a                    Specifically, this amendment changes
                                                  judgment and all the facts in your case.
                                                                                                           Federal performance standard for                      the words ‘‘any linear dimension’’ in the
                                                  If we decide to correct your                             ionizing radiation to correct a drafting
                                                  chronological age, we may correct it by                                                                        current regulation to read ‘‘every linear
                                                                                                           error regarding fluoroscopic equipment                dimension’’ (§ 1020.32(b)(4)(ii)(A)). The
                                                  subtracting the full number of weeks of                  measurement. We are taking this action
                                                  prematurity or a lesser number of                                                                              alternative performance standard,
                                                                                                           to ensure clarity and improve the                     § 1020.32(b)(4)(ii)(B), currently contains
                                                  weeks. If your developmental delay is                    accuracy of the regulations.
                                                  the result of your medically                                                                                   the same phrase but remains
                                                                                                           DATES: This rule is effective August 26,              unchanged. We are amending the
                                                  determinable impairment(s) and is not                    2015. Submit electronic or written
                                                  attributable to your prematurity, we will                                                                      language to make the performance
                                                                                                           comments on this direct final rule or its             standards mutually exclusive. This will
                                                  decide not to correct your chronological                 companion proposed rule by June 29,                   ensure clarity and improve the accuracy
                                                  age.                                                     2015.                                                 of the regulations.
                                                     (3) Notwithstanding the provisions in                 ADDRESSES:  You may submit comments                      FDA first proposed the performance
                                                  paragraph (b)(1) of this section, we will                by any of the following methods:                      standards in the Federal Register of
                                                  not compute a CCA if the medical                                                                               December 10, 2002 (67 FR 76056), to
                                                  evidence shows that your treating                        Electronic Submissions                                account for technological changes in
                                                  source or other medical source has                         Submit electronic comments in the                   fluoroscopic equipment. The proposed
                                                  already taken your prematurity into                      following way:                                        rule did not specify which measurement
                                                  consideration in his or her assessment                     • Federal eRulemaking Portal: http://               of the visible area of an image receptor
                                                  of your development. We will not                         www.regulations.gov. Follow the                       determined the applicable performance
                                                  compute a CCA when we find you                           instructions for submitting comments.                 standard (67 FR 76056 at 76092). When
                                                  disabled under listing 100.04 of the                                                                           we addressed comments to the proposed
                                                  Listing of Impairments.                                  Written Submissions                                   rule in the Federal Register of June 10,
                                                                                                              Submit written comments in the                     2005, we agreed with one comment that
                                                  § 416.926a       [Amended]                               following ways:                                       adding the words ‘‘any linear
                                                  ■ 5. Amend § 416.926a by removing                           • Mail/Hand delivery/Courier (for                  dimension’’ would clarify the
                                                  paragraphs (m)(6) and (m)(7) and                         paper submissions): Division of Dockets               determination of the performance
                                                                                                           Management (HFA–305), Food and Drug                   standard (70 FR 33998 at 34007).
                                                  redesignating paragraph (m)(8) as (m)(6).
                                                                                                           Administration, 5630 Fishers Lane, Rm.                   FDA ultimately incorporated the
                                                  ■ 6. Amend § 416.934 by adding                           1061, Rockville, MD 20852.                            phrase in two places, potentially
                                                  paragraphs (j) and (k) to read as follows:                  Instructions: All submissions received             reducing the clarity of the rule (70 FR
                                                                                                           must include the Docket No. FDA–                      33998 at 34040). Section
                                                  § 416.934 Impairments which may warrant                  2015–N–0828 for this rulemaking. All                  1020.32(b)(4)(ii) sets performance
                                                  a finding of presumptive disability or
                                                                                                           comments received may be posted                       standards based on a threshold, so the
                                                  presumptive blindness.
                                                                                                           without change to http://                             language for each standard should be
                                                  *       *    *     *    *                                www.regulations.gov, including any                    mutually exclusive. That is, only one
                                                     (j) Infants weighing less than 1200                   personal information provided. For                    standard, and not the other, should
                                                  grams at birth, until attainment of 1 year               additional information on submitting                  apply to the image receptor in question.
                                                  of age.                                                  comments, see the ‘‘Comments’’ heading                However, some image receptors may
                                                                                                           of the SUPPLEMENTARY INFORMATION                      have linear dimensions that are both
                                                     (k) Infants weighing at least 1200 but
                                                                                                           section of this document.                             greater than and less than 34 cm, for
                                                  less than 2000 grams at birth, and who
                                                                                                              Docket: For access to the docket to                example, receptors with a hexagonal
                                                  are small for gestational age, until
                                                                                                           read background documents or                          shape. In such cases, the performance
                                                  attainment of 1 year of age. (Small for
                                                                                                           comments received, go to http://                      standards may not be mutually
wreier-aviles on DSK5TPTVN1PROD with RULES




                                                  gestational age means a birth weight that
                                                                                                           www.regulations.gov and insert the                    exclusive, so both standards may appear
                                                  is at or more than 2 standard deviations                 docket number, found in brackets in the               to apply. This direct final rule amends
                                                  below the mean or that is less than the                  heading of this document, into the                    § 1020.32(b)(4)(ii)(A) to read ‘‘every
                                                  third growth percentile for the                          ‘‘Search’’ box and follow the prompts                 linear dimension’’ to ensure the
                                                  gestational age of the infant.)                          and/or go to the Division of Dockets                  standards are mutually exclusive. The
                                                  [FR Doc. 2015–08185 Filed 4–10–15; 8:45 am]              Management, 5630 Fishers Lane, Rm.                    amendment will improve the clarity and
                                                  BILLING CODE 4191–02–P                                   1061, Rockville, MD 20852.                            accuracy of the regulations.


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Document Created: 2015-12-18 11:21:59
Document Modified: 2015-12-18 11:21:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective June 12, 2015.
ContactCheryl 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.
FR Citation80 FR 19522 
RIN Number0960-AG28
CFR Citation20 CFR 404
20 CFR 416

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