31800 Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Rules and Regulations

Miami, FL, Miami Intl, ILS RWY 9R, Amdt

9

Miami, FL, Miami Intl, ILS RWY 12, Amdt

4

Miami, FL, Miami Intl, ILS RWY 27L, Amdt

23

Miami, FL, Miami Intl, ILS RWY 27R, Amdt

14

Orlando, FL, Orlando Intl, VOR/DME RNAV

RWY 36L, Orig, CANCELLED

Titusville, FL, Space Coast Regional, GPS

RWY 9, Orig-B

Chicago, IL, Chicago Midway, ILS RWY 13C,

Amdt 40

Winston Salem, NC, Smith Reynolds, VOR/

DME RWY 15, Amdt 1B

Winston Salem, NC, Smith Reynolds, NDB

RWY 33, Amdt 25B

Winston Salem, NC, Smith Reynolds, GPS

RWY 15, Orig-B

Winston Salem, NC, Smith Reynolds, GPS

RWY 33, Orig-B

New Philadelphia, OH, Harry Clever Field,

VOR–A, Amdt 1

New Philadelphia, OH, Harry Clever Field,

GPS RWY 14, Amdt 1

Portland, OR, Portland Intl, NDB OR GPS

RWY 28L, Amdt 4

Portland, OR, Portland Intl, NDB RWY 28R,

Amdt 11

Portland, OR, Portland Intl, ILS RWY 10R,

Amdt 31

Myrtle Beach, SC, Myrtle Beach Intl, ILS

RWY 17, Amdt 1

Myrtle Beach, SC, Myrthe Beach Intl, ILS

RWY 35, Amdt 1

Myrtle Beach, SC, Myrtle Beach Intl, GPS

RWY 35, Orig, CANCELLED

Myrtle Beach, SC, Myrtle Beach Intl, RNAV

RWY 35, Orig

Myrtle Beach, SC, Myrtle Beach Intl, RNAV

RWY 17, Orig

Madison, SD, Madison Muni, GPS RWY 33,

Orig-B

* * * Effective October 5, 2000

Cordova, AK, Merle K. (Mudhole) Smith,

GPS RWY 27, Orig-A

Arcata-Eureka, CA, Arcata, VOR RWY 14,

Amdt 7A

Montrose, CO, Montrose Regional, GPS RWY

13, Orig-B

Oxford, CT, Waterbury-Oxford, NDB RWY

18, Amdt 5A

Oxford, CT, Waterbury-Oxford, GPS RWY 18,

Orig-A

Springfield, IL, Capital, NDB OR GPS RWY

4, Amdt 18A

Springfield, IL, Capital, NDB RWY 22, OrigA

Sterling Rockfalls, IL, Whiteside Co Arpt-Jos

H Bittorf Fld, LOC BC RWY 7, Amdt 5A

Sterling Rockfalls, IL, Whiteside Co Arpt-Jos

H Bittorf Fld, NDB OR GPS RWY 7, Amdt

5A

Grand Rapids, MI, Gerald R. Ford Intl, VOR

RWY 17, Orig-C

Cleveland, OH, Cuyahoga County, LOC BC

RWY 5, Amdt 10B

Cleveland, OH, Cuyahoga County, NDB OR

GPS RWY 23, Amdt 8B

Columbus, OH, Rickenbacker Intl, NDB OR

GPS RWY 5R, Orig-A

Delarare, OH, Delaware Muni, VOR RWY 28,

Orig-A

Delaware, OH, Delaware Muni, GPS RWY 10,

Orig-A

Delaware, OH, Delaware Muni, GPS RWY 28,

Orig-A

Mansfield, OH, Mansfield Lahm Muni, VOR

OR GPS RWY 32, Amdt 6B

Wilmington, OH, Airborne Airpark, VOR/

DME OR GPS RWY 22R, Amdt 4C

Pawtucket, RI, North Central State, GPS RWY

23, Orig-A

Pawtucket, RI, North Central State, LOC RWY

5, Amdt 5A

Spearfish, SD, Black Hills-Clyde Ice Field,

GPS RWY 12, Orig-D

The FAA published an amendment in

Docket No. 29995, Amdt. No. 1986 to Part 97

of the Federal Aviation Regulations (65 FR

20896; dated Wednesday, April 19, 2000),

under § 97.23 effective June 15, 2000. That

amendment, which appeared on page 20898,

first column, lines 21 and 22, is corrected to

read as follows:

Lancaster, PA, Lancaster, VOR/DME OR GPS

RWY 8, Amdt 4

[FR Doc. 00–12559 Filed 5–18–00; 8:45 am]

BILLING CODE 4910–13–M

SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Regulations No. 4]

RIN 0960–AF03

Addition of Medical Criteria for

Evaluating Down Syndrome in Adults

AGENCY: Social Security Administration

(SSA).

ACTION: Final rule.

SUMMARY: We are adding a new listing

to evaluate non-mosaic Down syndrome

in adults. Our current regulations only

include a listing for evaluating Down

syndrome in children; we evaluate

claims filed by adults with Down

syndrome under other listings. We are

establishing a separate adult listing for

this disorder to acknowledge its lifelong

impact and severity. We expect that

these final rules will simplify and

expedite our adjudication of claims filed

by adults with non-mosaic Down

syndrome.

DATES: These rules are effective June 19,

2000.

FOR FURTHER INFORMATION CONTACT:

Michelle Hungerman, Social Insurance

Specialist, Office of Disability, Social

Security Administration, 3–A–9

Operations Building, 6401 Security

Boulevard, Baltimore, Maryland, 21235–

6401, (410) 965–2289, TTY (410) 966–

5609. For information on eligibility,

claiming benefits, or coverage of

earnings, call our national toll-free

number, 1–800–772–1213 or TTY 1–

800–325–0778.

SUPPLEMENTARY INFORMATION:

Background

We pay disability benefits under title

II of the Social Security Act (the Act) to

disabled individuals who are insured

under the Act. We also pay child’s

insurance benefits based on disability

and widow’s and widower’s insurance

benefits for disabled widows, widowers,

and surviving divorced spouses of

insured individuals. In addition, we

make Supplemental Security Income

(SSI) payments under title XVI of the

Act to persons who are disabled and

who have limited income and resources.

For adults under both the title II and

title XVI programs, and for persons

claiming child’s insurance benefits

based on disability under title II,

‘‘disability’’ means that an

impairment(s) results in an inability to

engage in any substantial gainful

activity. Disability must be the result of

any medically determinable physical or

mental impairment(s) that can be

expected to result in death or that has

lasted or can be expected to last for a

continuous period of at least 12 months.

Although the listings are contained

only in part 404, we incorporate them

by reference in the SSI program by

§ 416.925 of our regulations. The listings

are divided into part A and part B. We

apply the criteria in part A when we

evaluate impairments in adults, that is,

persons age 18 or over. The listings in

part A describe, for each of several

major body systems, impairments that

are considered severe enough to prevent

a person from doing any gainful activity.

As a result of medical advances in

disability evaluation and treatment, and

program experience, we are required to

periodically review and update the

listings. In the Notice of Proposed

Rulemaking (NPRM) we published in

the Federal Register (64 FR 55215) on

October 12, 1999, we indicated that we

would review these rules on July 2,

2001. However, based on our experience

adjudicating claims filed by adults with

non-mosaic Down syndrome, we believe

that these rules will continue to be valid

for our program purposes after that date.

Therefore, these rules will be in effect

for 8 years after the effective date,

unless we extend them, or revise and

issue them again.

Explanation of Final Rules

Aside from the change in the date on

which these rules will no longer be

effective, which we discussed above, we

have made no changes from the

proposed rules. We are adding a new

listing to evaluate claims filed by adults

who have non-mosaic Down syndrome.

Since 1990, we have evaluated claims

filed on behalf of children who have

Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Rules and Regulations 31801

non-mosaic Down syndrome under

listing 110.06, but we have not had a

Down syndrome listing for adults.

Instead, we evaluate most of these

claims under listing 12.05-Mental

Retardation—which requires

measurement of intellectual

functioning. Almost all adults with

Down syndrome also have moderate to

severe musculoskeletal abnormalities,

and many have other impairments,

including cardiac, gastrointestinal, oral/

facial and skeletal abnormalities. We

also evaluate the physical impairments

that such individuals may have under

the appropriate body system listings.

For children, current listing 110.06

represents what we have known for

some time: that when we obtain

appropriate evidence, virtually all

individuals who have non-mosaic Down

syndrome will be found disabled under

our rules. Therefore, listing 110.06 is

met by showing that the individual has

Down syndrome (excluding mosaic

Down syndrome) that has been

established by clinical findings,

including the characteristic physical

features, and laboratory evidence,

including chromosomal analysis.

When listing 110.06 is met, disability

is established from birth. In recognition

of the fact that non-mosaic Down

syndrome rarely, if ever, improves to the

point that an individual would not meet

our definition of disability, we are

adding a corresponding listing in part A.

We expect that this listing will simplify

and expedite our adjudication of cases

filed by adults with non-mosaic Down

syndrome. We also expect that these

rules will simplify and expedite the

process of performing disability

redeterminations at age 18 for

individuals who are eligible for SSI as

children on the basis of non-mosaic

Down syndrome. Although it is the only

listing in section 10.00, we are

numbering the new listing as listing

10.06, to correspond to listing 110.06 in

part B.

As in the childhood listing, final

listing 10.06 provides that an individual

age 18 or older who has non-mosaic

Down syndrome established by clinical

and laboratory findings, including

chromosomal analysis, is considered

disabled from birth. The new sections

10.00A and 10.00B in the preface to the

listing provide rules for documenting

non-mosaic Down syndrome. These

rules are similar to those in the

corresponding sections of the part B

listing, 110.00A and 110.00B. Final

10.00A includes a provision similar to

one in current 110.00A.2, which states

that an individual with Down syndrome

is considered disabled from birth. We

included this provision in the final rules

for adults to establish that the 12-month

duration requirement has been met.

As we have done in part B of our

listings, we are excluding mosaic Down

syndrome from the listing. Mosaic

Down syndrome is a rare form of the

condition that is manifested in a wide

range of impairment severity. The

condition can be profound and

disabling, but it can also be so slight as

to go undetected. Therefore, it would

not be appropriate to conclude that

mosaic Down syndrome is always

disabling. However, we will still find

individuals with mosaic Down

syndrome disabled if their impairments

meet or are medically equivalent in

severity to the requirements of other

listings. An individual whose mosaic

Down syndrome is ‘‘severe’’ but whose

impairment(s) do not meet or medically

equal the requirements of a listing may

also be found disabled at the fifth step

of the sequential evaluation process,

based on an assessment of his or her

residual functional capacity and

consideration of his or her age,

education, and work experience.

Finally, we are adding a new section

10.00C. This paragraph provides

guidance for evaluating other

chromosomal abnormalities.

Other Changes

Section 10.00 of part A of the listings

was reserved for future use. We are now

adding a new preface (10.00A, 10.00B,

and 10.00C) and new listing 10.06 in

this section. For this reason, and

because Down syndrome often has

physical as well as mental effects, we

are adding the heading ‘‘Multiple body

systems’’ for this section. We are also

making minor editorial changes to the

introductory text and table of contents

to part A of appendix 1, to reflect the

provisions of the final rules.

Public Comments

In the NPRM, we provided the public

with a 60-day comment period. In

response to the NPRM, we received

comments from 20 commenters. Most of

the comments came from individuals,

many of whom have family members

with Down syndrome. These

commenters supported the proposed

rules, without any suggested changes.

Several comments came from interested

organizations, including the National

Down Syndrome Congress, the National

Down Syndrome Society, the Arc of the

United States, and the Joseph P.

Kennedy, Jr., Foundation. Other

comments came from the State agencies

that make disability determinations for

us.

All of the commenters supported the

addition of an adult listing for

evaluating non-mosaic Down syndrome.

The summaries of the significant

comments we received and our

responses to them follow. We have tried

to summarize the commenters’ views

accurately, and have responded to all of

the significant issues raised that are

within the scope of the proposed rules.

Comment: Commenters from a State

agency that makes disability

determinations for us agreed that

including a separate listing for

evaluating non-mosaic Down syndrome

in adults was a good idea that would

help simplify the adjudication of these

cases. Two commenters from a State

agency asked us to consider additional

revisions to the listings to include other

genetic disorders. One of these

commenters specifically suggested we

add a listing for evaluating Lowe’s

syndrome.

Response: We have not adopted the

comment. Lowe’s syndrome is a genetic

disorder that primarily affects the eyes,

brain, and kidneys. As with most

genetic disorders, the physical stigmas

and the degree of mental retardation

associated with Lowe’s syndrome vary

widely. Therefore, we cannot conclude

that the impairment is always of listinglevel severity. Section 10.00C of these

final rules provides that genetic

disorders other than non-mosaic Down

syndrome should be evaluated under

the listings for the affected body system.

We believe that this section will allow

us to evaluate appropriately the effects

of other genetic disorders, including

Lowe’s syndrome.

Comment: One commenter indicated

that laboratory testing for Down

syndrome is generally done at birth or

soon thereafter. This commenter stated

that, since the listing would apply to

individuals who are at least 18 years

old, the result of any laboratory testing

might be difficult to obtain due to the

passage of time. The commenter

questioned what type of medical

evidence could be used to establish the

diagnosis under the provisions of

section 10.00B of these final rules. The

commenter also asked if SSA would pay

for chromosomal analysis if needed.

Response: Section 10.00B of the final

rules provides that, in lieu of a copy of

the actual laboratory report, medical

evidence that is persuasive that a

positive diagnosis has been confirmed

by an appropriate laboratory testing, at

some time prior to evaluation, is

acceptable documentation of the

existence of non-mosaic Down

syndrome. Under this provision, the file

must contain an acceptable reference to

the fact that testing was conducted and

the results of that testing. The

referenced results must be consistent

31802 Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Rules and Regulations

with other evidence in file, e.g., the

description of the usual abnormal

physical findings, the individual’s

educational history, or the results of

psychological testing, if performed.

Generally, this information will give us

sufficient evidence to establish the

diagnosis. However, in the unusual case

in which it becomes necessary, SSA can

purchase the appropriate blood test.

Comment: Another commenter from a

State agency that makes disability

determinations for us agreed that this

listing will assist in the adjudication of

adult cases, age-18 redetermination

cases, and continuing disability review

(CDR) cases. This commenter asked

whether we could revise the listing to

indicate that medical improvement is

not expected and that the cases

adjudicated under listing 10.06 be

diaried for 7 years.

Response: After we find that an

individual is disabled, we must evaluate

his or her continued eligibility for

benefits from time to time. SSA issues

guidelines on how to schedule these

reviews through internal operating

instructions in our Program Operations

Manual System (POMS). We will

consider the guidelines recommended

by the commenter when we issue POMS

instructions on how to schedule CDR

diaries for adults found disabled based

on non-mosaic Down syndrome.

Comment: One commenter

representing an interested organization

expressed support for adding a new

listing to provide for the evaluation of

Down syndrome for adults. This

commenter urged SSA to provide

training to all adjudicators when these

rules become final.

Response: We agree with the

commenter’s recommendation. In

accordance with our usual practice, we

will conduct training for all adjudicators

after the final rules are published.

For the reasons given in our responses

to the comments on the proposed rules,

we have not made further changes to the

text of the proposed rules. Other than

the one change discussed above, we are

publishing the proposed regulations as

final regulations.

Regulatory Procedures

Executive Order 12866

We have consulted with the Office of

Management and Budget (OMB) and

determined that these final rules do not

meet the criteria for a significant

regulatory action under Executive Order

12866. Thus, the final rules were not

subject to OMB review. We have also

determined that these final rules meet

the plain language requirement of

Executive Order 12866 and the

President’s memorandum of June 1,

1998 (63 FR 31885).

Regulatory Flexibility Act

We certify that these final rules will

not have a significant economic impact

on a substantial number of small entities

because they only affect individuals.

Therefore, a regulatory flexibility

analysis, as provided in the Regulatory

Flexibility Act, as amended, is not

required.

Paperwork Reduction Act

These final rules impose no reporting/

recordkeeping requirements

necessitating clearance by OMB.

(Catalog of Federal Domestic Assistance

Program Nos. 96.001, Social SecurityDisability Insurance; 96.002, Social SecurityRetirement Insurance; 96.004, Social

Security-Survivors Insurance; 96.006,

Supplemental Security Income)

List of Subjects in 20 CFR Part 404

Administrative practice and

procedure, Blind, Disability benefits,

Old-Age, Survivors and Disability

Insurance, Reporting and recordkeeping

requirements, Social Security.

Dated: May 3, 2000.

Kenneth S. Apfel,

Commissioner of Social Security.

For the reasons set out in the

preamble, we are amending part 404,

subpart P, of chapter III of title 20 of the

Code of Federal Regulations to read as

follows:

PART 404—FEDERAL OLD-AGE,

SURVIVORS AND DISABILITY

INSURANCE (1950– )

1. The authority citation for subpart P

of part 404 continues to read as follow:

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

(h), 216(i), 221(a) and (i), 222(c), 223, 225,

and 702(a)(5) of the Social Security Act (42

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

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

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

Stat. 2105, 2189.

Appendix 1 to Subpart P of Part 404—

[Amended]

2. Appendix 1 to subpart P of part 404

is amended as follows:

a. Item 11 of the introductory text

before Part A of appendix 1 is revised.

b. The Table of Contents for part A of

appendix 1 is amended by adding

section 10.00.

c. Section 10.00 is added to Part A of

appendix 1.

The added and revised text reads as

follows:

Appendix 1 To Subpart P of Part 404—

Listing of Impairments

* * * * *

11. Multiple Body Systems (10.00):

June 19, 2008, and (10.00): July 2, 2001.

* * * * *

Part A

* * * * *

10.00 Multiple Body Systems

* * * * *

10.00 MULTIPLE BODY SYSTEMS

A. Down syndrome (except for mosaic

Down syndrome (see 10.00C))

established by clinical findings,

including the characteristic physical

features, and laboratory evidence is

considered to meet the requirement of

listing 10.06, commencing at birth.

B. Documentation must include

confirmation of a positive diagnosis by

a clinical description of the usual

abnormal physical findings associated

with the condition and definitive

laboratory tests, including chromosomal

analysis. Medical evidence that is

persuasive that a positive diagnosis has

been confirmed by appropriate

laboratory testing, at some time prior to

evaluation, is acceptable in lieu of a

copy of the actual laboratory report.

C. Other chromosomal abnormalities,

e.g., mosaic Down syndrome, fragile X

syndrome, phenylketonuria, and fetal

alcohol syndrome, produce a pattern of

multiple impairments but manifest in a

wide range of impairment severity.

Therefore, the effects of these

impairments should be evaluated under

the affected body system.

10.01 Category of Impairments,

Multiple Body Systems

10.06 Down syndrome (excluding

mosaic Down syndrome) established by

clinical and laboratory findings, as

described in 10.00B. Consider the

individual disabled from birth.

* * * * *

[FR Doc. 00–12593 Filed 5–18–00; 8:45 am]

BILLING CODE 4191–02–U