49636 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Proposed Rules

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

Saab Aircraft AB: Docket 97–NM–126–AD.

Applicability: Model SAAB 2000 series

airplanes having serial numbers –002

through –043 inclusive, certificated in any

category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (b) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent discrepancies of the check

valve, which could result in improper

functioning of the engine fire extinguishing

system, accomplish the following:

(a) Within 2 months after the effective date

of this AD, perform an inspection of the twoway check valve on the engine fire

extinguishing system for discrepancies, in

accordance with Saab Service Bulletin 2000–

26–010, dated July 5, 1996. If any

discrepancy is found, prior to further flight,

install a new two-way check valve in

accordance with the service bulletin.

(b) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager,

standardization Branch, ANM–113, FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Standardization

Branch, ANM–113.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Standardization Branch,

ANM–113.

(c) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

Issued in Renton, Washington, on

September 17, 1997.

James V. Devany,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–25168 Filed 9–22–97; 8:45 am]

BILLING CODE 4910–13–U

SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

RIN 0960–AE42

Federal Old-Age, Survivors, and

Disability Insurance; Determining

Disability and Blindness; Revision to

Medical-Vocational Guidelines

AGENCY: Social Security Administration.

ACTION: Proposed rules.

SUMMARY: We propose to clarify

§ 201.00(h) of the medical-vocational

guidelines in appendix 2 of subpart P of

regulations part 404. This section

provides guidance for evaluating

disability in individuals under age 50

who have a severe impairment(s) that

does not meet or equal in severity the

criteria of any listed impairment in

appendix 1 of subpart P, but who have

a residual functional capacity for no

more than the full range of sedentary

work and cannot do any past relevant

work. The proposed revisions are

intended only to clarify the current

rules; they are not intended to change

any policies.

DATES: To be sure your comments are

considered, we must receive them no

later than November 24, 1997.

ADDRESSES: Comments should be

submitted in writing to the

Commissioner of Social Security, P.O.

Box 1585, Baltimore, MD 21235, sent by

telefax to (410) 966–2830, sent by e-mail

to ‘‘regulations@ssa.gov,’’ or delivered

to the Division of Regulations and

Rulings, Social Security Administration,

3–B–1 Operations Building, 6401

Security Boulevard, Baltimore, MD

21235, between 8:00 a.m. and 4:30 p.m.

on regular business days. Comments

may be inspected during these same

hours by making arrangements with the

contact person shown below.

FOR FURTHER INFORMATION CONTACT:

Robert Augustine, Legal Assistant,

Division of Regulations and Rulings,

Social Security Administration, 6401

Security Boulevard, Baltimore, MD

21235, (410) 966–5121 for information

about these rules. For information on

eligibility or claiming benefits, call our

national toll-free number, 1–800–772–

1213.

SUPPLEMENTARY INFORMATION: The Social

Security Act (the Act) provides in title

II for the payment of disability benefits

to workers insured under the Act. Title

II also provides, under certain

circumstances, child’s insurance

benefits for persons who become

disabled before age 22 and widow’s and

widower’s insurance benefits based on

disability for widows, widowers, and

surviving divorced spouses of insured

individuals. In addition, the Act

provides in title XVI for supplemental

security income (SSI) payments to

persons who are disabled and 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’’ is defined in the Act as the

‘‘inability to engage in any substantial

gainful activity by reason of any

medically determinable physical or

mental impairment which can be

expected to result in death or which has

lasted or can be expected to last for a

continuous period of not less than 12

months.’’ Sections 223(d) and 1614(a) of

the Act also state that the individual

‘‘shall be determined to be under a

disability only if his physical or mental

impairment or impairments are of such

severity that he is not only unable to do

his previous work but cannot,

considering his age, education, and

work experience, engage in any other

kind of substantial gainful work which

exists in the national economy,

regardless of whether such work exists

in the immediate area in which he lives,

or whether a specific job vacancy exists

for him, or whether he would be hired

if he applied for work.’’

To implement the process for

determining whether an individual is

disabled based upon this statutory

definition, our longstanding regulations

at §§ 404.1520 and 416.920 provide for

a five-step sequential evaluation process

as follows:

1. Is the claimant engaging in

substantial gainful activity? If the

claimant is working and the work is

substantial gainful activity, we find that

he or she is not disabled. Otherwise, we

proceed to step 2 of the sequence.

2. Does the claimant have an

impairment or combination of

impairments which is severe? If the

claimant does not have an impairment

or combination of impairments which is

severe, we find that he or she is not

disabled. If the claimant has an

impairment or combination of

impairments which is severe, we

proceed to step 3 of the sequence.
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Proposed Rules 49637

3. Does the claimant’s severe

impairment(s) meet or equal in severity

the criteria of a listed impairment in

appendix 1 of subpart P of part 404? If

so, and the duration requirement is met,

we find that he or she is disabled. If not,

we proceed to step 4 of the sequence.

4. Does the claimant’s severe

impairment(s) prevent him or her from

doing his or her past relevant work,

considering his or her residual

functional capacity? If not, we find that

he or she is not disabled. If so, we

proceed to step 5 of the sequence.

5. Does the claimant’s impairment(s)

prevent him or her from performing

other work that exists in the national

economy, considering his or her

residual functional capacity, age,

education, and work experience? If so,

and the duration requirement is met, we

find that he or she is disabled. If not, we

find that he or she is not disabled.

As discussed in § 404.1569, at step 5

of the sequential evaluation process we

provide medical-vocational rules in

appendix 2 of subpart P of part 404. (By

reference, § 416.969 of the regulations

provides that appendix 2 is also

applicable to adults claiming SSI

payments based on disability.) These

rules take administrative notice of the

existence of numerous unskilled

occupations at exertional levels defined

in the regulations, such as ‘‘sedentary,’’

‘‘light,’’ and ‘‘medium,’’ and, based

upon a consideration of the individual’s

residual functional capacity, age,

education, and work experience, either

direct decisions or are used as a

framework for making decisions at step

5.

The revisions we are proposing would

clarify one paragraph in appendix 2,

section 201.00(h), which discusses the

evaluation of the claims of ‘‘younger

individuals’’ (i.e., individuals who have

not attained age 50) who have a residual

functional capacity limited to the full

range of sedentary work

administratively noticed by the rules in

table No. 1 of appendix 2 or who can

perform some sedentary work but not

the full range of such work.

Summary of Proposed Changes

We propose to clarify section

201.00(h) in appendix 2. This section

discusses the evaluation of disability

claims of ‘‘younger individuals’’ (i.e.,

individuals who have not attained age

50) who have a severe impairment(s)

that does not meet or equal in severity

the criteria of any listing but who have

a residual functional capacity for no

more than the full range of sedentary

work. The proposed changes are

intended only as clarifications. None of

these proposed revisions is intended to

change the meaning of the current rules.

Specifically, we propose to clarify the

second sentence of section 201.00(h) in

appendix 2, which states that for

workers who are age 45–49, ‘‘age is a

less positive factor’’ than for individuals

who are younger than age 45. The

proposed clarification would more

clearly explain that, for workers who are

age 45–49, age is a ‘‘less advantageous

factor for making an adjustment to other

work than for those who are age 18–44.’’

This is consistent with our longstanding

policy that, at step 5 of the sequential

evaluation process, the issue is whether

the individual is able to make an

adjustment to work other than any past

relevant work considering his or her

residual functional capacity, age,

education, and work experience, and

would only clarify what we mean by the

phrase ‘‘a less positive factor.’’

In the third sentence, clause (3), we

propose to change the phrases ‘‘relevant

past work’’ and ‘‘vocationally relevant

past work,’’ to ‘‘past relevant work’’ to

clarify our intended meaning and for

consistency in our terminology. We also

propose to clarify clause (4) of the same

sentence to better explain that the term

‘‘illiterate’’ means that the individual is

illiterate in English. This will make

clearer our original intent that the fourth

clause describes individuals who are

either 1) unable to communicate in

English (and, by definition, illiterate in

English) or 2) able to speak and

understand English but illiterate in

English.

We propose to revise the fourth

sentence to be consistent with the

foregoing proposed revisions. We

propose to revise the statement ‘‘age is

a more positive factor for those who are

under age 45’’ to ‘‘for those who are

under age 45, age is a more

advantageous factor for making an

adjustment to other work’’ to

correspond to the proposed changes in

the second sentence. Likewise, we

propose to clarify that ‘‘illiterate’’ means

illiterate in English as in the proposed

changes to the third sentence.

We propose to add four new

sentences after the fifth sentence to

explain the impact of a maximum

sustained work capacity for no more

than the full range of sedentary work on

an individual’s ability to do other work.

The intent is twofold: 1) to make clear

that such capacity reflects a very serious

functional limitation and must be

appropriately documented by the

evidence in the record; and 2) to make

clear that a finding that an individual is

limited to less than the full range of

sedentary work does not necessarily

equate with a finding of disability. If an

individual is unable to perform past

relevant work and has a maximum

sustained work capacity for less than

the full range of sedentary work (and the

medical-vocational rules would not

direct a decision of disabled if the

individual was limited to the full range

of sedentary work), consideration must

still be given to whether there is other

work in the national economy that the

individual is able to do.

We also propose to add language to

the fifth sentence to make it explicitly

clear that a finding of ‘‘disabled’’ is also

not precluded for individuals age 45–49

who do not meet all of the criteria of a

specific rule and who do not have the

ability to perform a full range of

sedentary work.

We also propose to delete without

replacement the two case examples from

section 201.00(h). The intent of these

examples is merely to reinforce a

concept already reflected in this

paragraph; i.e., that, using the rules as

a framework for decisionmaking, a

conclusion of ‘‘disabled’’ may be, but is

not necessarily, warranted for

individuals under age 45 who do not

satisfy all of the criteria of a specific

rule and who do not have the residual

functional capacity to do a full range of

sedentary work.

We propose to delete the examples

because they are no longer needed and

our adjudicative experience has shown

that they can be unclear. For example,

we have received questions about

whether example 2 applies only to cases

involving mental impairments or

whether it could apply to other types of

impairments. Although our intent has

always been that the case examples are

applicable to all types of impairments,

their removal will avoid possible

confusion and help ensure consistency

in decisionmaking.

In addition, over the past several

years we have been following a practice

of not using case examples in our

disability regulations unless they serve

some necessary purpose, such as when

the rules present a new and complex

policy where we believe that an

example or examples would be helpful

for understanding the new policy. We

believe the examples in the current

rules no longer serve such a purpose

and that it is better to delete them.

Again, this is not intended as a change

in policy.

Finally, we are also making minor

editorial changes, to improve the

consistency of terminology in appendix

2.
49638 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Proposed Rules

Regulatory Procedures

Executive Order 12866

We have consulted with the Office of

Management and Budget (OMB) and

determined that these proposed rules

meet the criteria for a significant

regulatory action under Executive Order

12866. Thus, they were subject to OMB

review. There are no program or

administrative costs or savings

associated with these proposed rules.

Therefore, no assessment of costs and

benefits is required.

Regulatory Flexibility Act

We certify that these proposed

regulations will not have a significant

economic impact on a substantial

number of small entities because they

affect only individuals. Therefore, a

regulatory flexibility analysis, as

provided in Public Law 96–354, the

Regulatory Flexibility Act, is not

required.

Paperwork Reduction Act

These proposed regulations will

impose no new reporting or

recordkeeping requirements requiring

OMB clearance.

(Catalog of Federal Domestic Assistance

Program Nos. 96.001, Social Security

Disability Insurance; 96.006, Supplemental

Security Income)

List of Subjects in 20 CFR Part 404

Administrative practice and

procedure, Blind, Death benefits,

Disability benefits, Old-Age, Survivors

and Disability Insurance, Reporting and

recordkeeping requirements, Social

Security.

Dated: June 16, 1997.

John J. Callahan,

Acting Commissioner of Social Security.

For the reasons set out in the

preamble, part 404, subpart P, Chapter

III of Title 20, Code of Federal

Regulations, is proposed to be amended

as set forth below.

PART 404—FEDERAL OLD-AGE,

SURVIVORS AND DISABILITY

INSURANCE (1950– )

1. The authority citation for subpart P

continues to read as follows:

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

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

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

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

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

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

Stat. 2105, 2189.

2. Section 201.00(h), appendix 2,

subpart P, is revised to read as follows:

APPENDIX 2 TO SUBPART P—

MEDICAL-VOCATIONAL GUIDELINES

* * * * *

201.00 Maximum sustained work capability

limited to sedentary work as a result of

severe medically determinable

impairment(s).

* * * * *

(h) The term younger individual is used to

denote an individual age 18 through 49. For

individuals who are age 45–49, age is a less

advantageous factor for making an

adjustment to other work than for those who

are age 18–44. Accordingly, for such

individuals who: (1) are restricted to

sedentary work, (2) are unskilled or have no

transferable skills, (3) have no past relevant

work or who can no longer perform past

relevant work, and (4) are unable to

communicate in English, or are able to speak

and understand English but are illiterate in

English, a finding of ‘‘disabled’’ is warranted.

For individuals who are under age 45, age is

a more advantageous factor for making an

adjustment to other work and is usually not

a significant factor in limiting such

individuals’ ability to make an adjustment to

other work, even an adjustment to unskilled

sedentary work, and even when the

individuals are unable to communicate in

English or are illiterate in English. A finding

of ‘‘disabled’’ is not precluded for those

individuals under age 45 (and those age 45–

49 for whom rule 201.17 does not direct a

decision of disabled) who do not meet all of

the criteria of a specific rule and who do not

have the ability to perform a full range of

sedentary work. However, the inability to

perform the full range of sedentary work does

not necessarily equate with a finding of

‘‘disabled.’’ In deciding whether an

individual who is limited to a partial range

of sedentary work is able to make an

adjustment to work other than any past

relevant work, the adjudicator is required to

make an individualized determination

considering the individual’s remaining

occupational base, age, education, and work

experience. Further, ‘‘sedentary work’’

represents a significantly restricted range of

work, and individuals with a maximum

sustained work capability limited to

sedentary work have very serious functional

limitations. Therefore, a finding that an

individual is limited to less than the full

range of sedentary work will be based on a

careful consideration of the evidence of an

individual’s medical impairment(s) and the

limitations and restrictions attributable

thereto. Such evidence must support the

finding that an individual’s residual

functional capacity is limited to less than the

full range of sedentary work.

* * * * *

[FR Doc. 97–25125 Filed 9–22–97; 8:45 am]

BILLING CODE 4190–29–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 200

[Docket No. 96N–0048]

Sterility Requirements for Inhalation

Solution Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations to require that all

inhalation solutions for nebulization be

sterile. Inhalation solutions for

nebulization, as the term is used in this

document, refers to inhalation solutions

administered as a fine aqueous mist

created by an atomizer or nebulizer.

Currently, approximately half of these

products are manufactured to be sterile.

Based on reports of adverse drug

experiences from contaminated

nonsterile inhalation solutions for

nebulization and recalls of these

products, FDA is taking this action to

ensure the safety and effectiveness of

these solutions.

DATES: Written comments by December

22, 1997. Submit written comments on

the information collection requirements

by October 23, 1997. FDA proposes that

any final rule that may issue based on

this proposal become effective March

23, 1998.

ADDRESSES: Submit written comments

on this proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Submit written comments on the

information collection requirements to

the Office of Information and Regulatory

Affairs, Office of Management and

Budget (OMB), New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Carol E. Drew, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

Inhalation solutions for nebulization

are used to treat a variety of breathing

disorders. Currently, approximately half

of the marketed products are

manufactured to be sterile. Those

products not manufactured to be sterile

are often manufactured under assigned