Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Proposed Rules 48963

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend part

39 of the Federal Aviation Regulations

(14 CFR part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding a new airworthiness directive to

read as follows:

Sikorsky Aircraft Corporation: Docket No.

96–SW–29–AD.

Applicability: Model S–61 A, D, E, L, N,

NM, R, and V helicopters, with main rotor

shaft (shaft), part number (P/N) S6135–

20640–001, S6135–20640–002, or S6137–

23040–001, installed, certificated in any

category.

Note 1: This AD applies to each helicopter

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

helicopters that have been modified, altered,

or repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must use the authority

provided in paragraph (d) to request approval

from the FAA. This approval may address

either no action, if the current configuration

eliminates the unsafe condition, or different

actions necessary to address the unsafe

condition described in this AD. Such a

request should include an assessment of the

effect of the changed configuration on the

unsafe condition addressed by this AD. In no

case does the presence of any modification,

alteration, or repair remove any helicopter

from the applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously.

To detect a fatigue crack in the shaft, that

could result in shaft structural failure, loss of

power to the main rotor, and subsequent loss

of control of the helicopter, accomplish the

following:

(a) Within the next 30 calendar days or 240

hours time-in-service (TIS) after the effective

date of this AD, whichever occurs first,

determine if the shaft has been used in

repetitive external lift (REL) operations. REL

operation is defined as operation during

which the average number of external lifts

equals or exceeds six per flight hour for any

250 hour TIS period during the main gearbox

overhaul interval. An external lift is defined

as a flight cycle in which an external load is

picked up, the helicopter is repositioned

(through flight or hover), and the helicopter

hovers and releases the load and departs or

lands and departs. Record the total number

of hours TIS during which external lifts have

been conducted, as well as the number of

external lifts conducted during each hour, on

the component log card or equivalent record.

If the number of external lifts cannot be

determined, assume 6 external lifts were

conducted during each hour TIS in which

external lifts were conducted. If the hours

TIS of external lift operations cannot be

determined, assume REL operations were

conducted.

(b) For shafts used in REL operations,

within the next 1,000 hours TIS after the

effective date of this AD, conduct a nondestructive inspection (NDI) for cracks in the

shaft in accordance with the Overhaul

Manual. If a crack is discovered in a shaft,

remove the shaft and replace it with an

airworthy shaft. Mark the removed airworthy

shafts and the replacement shafts in

accordance with the Accomplishment

Instructions in paragraphs 2E and 2F of

Sikorsky Aircraft Corporation ASB No.

61B35–68, dated July 19, 1996. Once a shaft

has been designated and marked as an REL

shaft, it is life-limited accordingly for the

remainder of that shaft’s airworthy service

life.

(c) Retire all shafts that have been used in

REL operations as follows:

(1) Shafts that have been modified in

accordance with Sikorsky Customer Service

Notice 6135–10, dated March 18, 1987, and

Sikorsky ASB No. 61B35–53, dated December

2, 1981 (modified REL shafts), must be

removed from service on or before attaining

2,000 hours TIS.

(2) Shafts that have not been modified in

accordance with Sikorsky Customer Service

Notice 6135–10, dated March 18, 1987, and

Sikorsky ASB No. 61B35–53, dated December

2, 1981 (unmodified REL shafts), must be

removed from service on or before attaining

1,500 hours TIS.

(d) 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, Boston

Aircraft Certification Office. Operators shall

submit their requests through an FAA

Principal Maintenance Inspector, who may

concur or comment and then send it to the

Manager, Boston Aircraft Certification Office.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Boston Aircraft

Certification Office.

(e) This AD revises the Limitations section

of the maintenance manual by establishing

new retirement lives of 1,500 hours TIS for

unmodified REL shafts and 2,000 hours TIS

for modified REL shafts.

(f) 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 helicopter

to a location where the requirements of this

AD can be accomplished.

Issued in Fort Worth, Texas, on September

12, 1997.

Eric Bries,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 97–24795 Filed 9–17–97; 8:45 am]

BILLING CODE 4910–13–U

SOCIAL SECURITY ADMINISTRATION

20 CFR Parts 404 and 416

RIN 0960–AE74

Federal Old-Age, Survivors, and

Disability Insurance Benefits;

Supplemental Security Income for the

Aged, Blind, and Disabled;

Organization and Procedures;

Application of Circuit Court Law

AGENCY: Social Security Administration

(SSA).

ACTION: Proposed rules.

SUMMARY: These proposed regulations

would revise the current regulations

governing how we apply holdings of the

United States Courts of Appeals that we

determine conflict with our

interpretation of the Social Security Act

or regulations in adjudicating claims

under title II and title XVI of the Social

Security Act (the Act). The regulations

explain the new goal we have adopted

to ensure that Acquiescence Rulings

(ARs) are developed and issued

promptly and the new procedures we

are implementing to identify cases

pending in the administrative process

which might be affected by ARs.

DATES: To be sure your comments are

considered, we must have them no later

than November 17, 1997.

ADDRESSES: Comments should be

submitted in writing to the

Commissioner of Social Security, P.O.

Box 1585, Baltimore, Maryland 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:

Harry J. Short, Legal Assistant, Division

of Regulations and Rulings, Social

Security Administration, 6401 Security

Boulevard, Baltimore MD 21235, (410)

965–6243 for information about these

rules. For information on eligibility or

claiming benefits, call our national toll

free number, 1–800–772–1213.

SUPPLEMENTARY INFORMATION: On

January 11, 1990, (55 FR 1012) we

published final regulations to

implement a revised policy for applying

circuit court holdings that conflict with

our interpretation of the Act or

regulations to subsequent claims within

that circuit involving the same issue.
48964 Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Proposed Rules

Under those regulations, which are set

out at 20 CFR 404.985 and 416.1485, we

prepare Acquiescence Rulings which

explain the circuit court holdings and

provide binding guidance to

adjudicators on how to apply the

holding to subsequent claims within the

circuit involving the same issue. Those

regulations reflected the agency’s

decision in 1985 to abandon its prior

policy of applying conflicting circuit

court holdings only to the named party

or parties to the decision, rather than to

other cases pending before an

Administrative Law Judge or the

Appeals Council involving the same

issue or issues. The 1990 regulations

expanded the 1985 policy decision to

apply an AR to all levels of

adjudication, as appropriate.

After the 1990 regulations were

adopted, allegations that the agency

refused to acquiesce in circuit court

decisions with holdings in conflict with

our interpretation of the Act or

regulations declined dramatically. A

major goal of the 1990 regulations has

been achieved because the circuit courts

have found virtually no cause to cite the

agency for failing to adhere to circuit

court precedent.

On July 2, 1996, we issued Social

Security Ruling 96–1p (61 FR 34470)

reaffirming the rules established in the

1990 regulations. Since that time, we

have reviewed our rules and our

implementing procedures to determine

what changes could be instituted to

further improve the acquiescence

process. Our review has led us to

conclude that we should reaffirm an

important principle regarding the

impact of litigation on claims

adjudication and, through these final

regulations, amend the 1990 regulations

in two significant respects.

The Role of Litigation in the

Policymaking Process

Our review indicated that it is

important to reaffirm the principle that

our goal in administering our programs

is to have uniform, national program

standards. Our procedures, which

provide for acquiescence within the

circuit when a circuit court issues a

decision containing a holding which

conflicts with our interpretation of the

Act or regulations, result in differing

policies in different sections of the

country. This situation is not desirable

and ordinarily should not, if possible,

continue indefinitely.

Therefore, we wish to make it clear

that generally ARs are temporary

measures. When we receive a circuit

court decision containing a holding

which conflicts with our interpretation

of the Act or regulations, we consider

whether the rule at issue should be

changed on a nationwide basis to

conform to the court’s holding. If we

continue to believe that our

interpretation of the statute or

regulations at issue is correct and we

seek further judicial review of the

circuit court’s decision, we will stay

further development of the AR until the

judicial review process runs its course.

If our assessment shows that we should

change our rules and adopt a circuit

court’s holding nationwide, we will, at

the time we publish the AR, have

determined the steps necessary to do so.

This may require changing our

regulations or rulings; it may also

require seeking a clarifying legislative

change to the Act. In this case, however,

we would proceed to issue an AR since

adopting the rules nationwide

inevitably requires a significant period

of time.

Similarly, if our assessment is that our

rules are correct but we are unable to

resolve the matter by seeking further

judicial review, we will issue an AR and

at the time we publish the AR have

determined the appropriate steps to

attempt to address the issue which was

the subject of the circuit court’s holding.

This may mean issuing clarifying

regulations or seeking legislation. There

are certain instances when an issue

cannot be resolved, such as a

constitutional issue which the Supreme

Court chooses not to review and,

therefore, an AR may remain in effect.

Although our goal to have uniform

national standards is implicit in the

current regulations, we are including in

this preamble, an explicit statement of

our commitment to maintaining a

uniform nationwide system of rules and

regulations. In addition to making minor

editorial corrections to the current

regulations, these proposed rules would

amend the regulations in two

substantive areas, as follow:

Establishing a Timeliness Goal for

Issuing Acquiescence Rulings

A common criticism regarding the

current process involves the length of

time it takes for SSA to prepare and

issue an AR. As a result, we have

reassessed our procedures and have

decided that we will release an AR for

publication in the Federal Register no

later than 120 days from the time we

receive a precedential circuit court

decision for which the AR is being

issued, unless further judicial review of

that decision is pending. We propose to

add new sections 404.985(b)(1) and

416.1485(b)(1) so that the public is fully

informed of this timeframe.

Identifying Pending Claims Which May

Be Affected by an AR

When we published the 1990

regulations, we noted that a number of

commenters on the 1988 proposed

regulations (53 FR 46628 (November 18,

1988)) urged that we take action to

identify and list pending claims that

might be affected by an AR. In the

response to that comment, we stated:

As a matter of operational necessity, some

time will always elapse between the date of

a court decision and the time that we could

notify all adjudicators to begin listing cases

which might be affected by its holding. Thus,

a substantial number of cases would not be

listed for later readjudication. The process

which these comments suggest presumes

instantaneous, comprehensive identification

of all cases, which operationally we cannot

accomplish. Therefore, despite the fact that

requiring claimants to seek readjudication

does require some action on their part, we

have concluded that this is the most efficient

and effective way to proceed and have not

adopted these comments in the final

regulations.

(55 FR 1012, 1013). The basic facts

noted in our response remain valid.

Despite improved technology, it is still

operationally impossible for us to

identify all pending claims that might

be affected by an AR. However, we have

reassessed this situation and have now

decided that it would be a significant

benefit to claimants if we were to act as

expeditiously as possible to identify

pending claims that might be affected by

an AR, even though we will not be able

to identify all such claims.

Therefore, as described in the

proposed new sections 404.985(b)(3)

and 416.1485(b)(3), we are

implementing the following procedures.

As soon as possible after we receive a

circuit court decision that we find may

contain a holding that conflicts with our

interpretation of the Act or regulations,

we will develop and provide our

adjudicators with criteria that they will

use to identify pending claims we are

deciding within the relevant circuit that

might be affected, if we subsequently

determine that an AR is required. If an

AR is subsequently released, a notice

will be sent informing the claimant in

these cases that might be affected by the

AR that an AR has been issued that

might affect the claim. The notice to the

claimant will also explain the

procedures for obtaining a

readjudication of the claim under the

AR. If we develop criteria and begin

identifying cases but subsequently

determine that an AR is not required,

the notices will not be sent.

We will notify adjudicators of the

appropriate criteria to be used to

identify cases no later than 10 days after
Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Proposed Rules 48965

we receive a circuit court decision that

we determine may contain a holding

which conflicts with our interpretation

of the Act or regulations. Although we

believe that the new procedure to

identify pending claims within the

relevant circuit that might be affected

will greatly reduce the number of

claimants who would have to learn of

the issuance of the AR through the

Federal Register publication of it or

otherwise, the new procedure will not

capture everyone. For this reason, we

have retained the readjudication

procedure in sections 404.985(b)(2) and

416.1485(b)(2) to ensure the protection

of all claimants. Additionally, if a

claimant or an adjudicator brings to our

attention that a claim could potentially

be affected by a circuit court decision

that might become the subject of an AR,

we will consider identifying that case

pending a decision as to whether an AR

is necessary in the circuit court decision

in question.

Electronic Version

The electronic version of this

document is available on the Federal

Bulletin Board (FBB) at 9:00 a.m. on the

date of publication in the Federal

Register. To download the file, modem

dial (202) 512–1387. The FBB

instructions will explain how to

download the file and the fee. This file

is in WordPerfect and will remain on

the FBB during the comment period.

Regulatory Procedures

Executive Order 12866

We have consulted with the Office of

Management and Budget (OMB) and

determined that these rules do not meet

the criteria for a significant regulatory

action under Executive Order 12866.

Thus, they are not subject to OMB

review.

Regulatory Flexibility Act

We certify that these regulations will

not have a significant economic impact

on a substantial number of small entities

because these rules affect only

individuals. Therefore, a regulatory

flexibility analysis as provided in the

Regulatory Flexibility Act, as amended,

is not required.

Paperwork Reduction Act

These proposed rules contain

reporting requirements in Part 404,

section 404.985(b)(2) and

416.1485(b)(2). As required by 42 U.S.C.

section 3507, as amended by section 2

of the Paperwork Reduction Act of 1995,

we will submit a copy to the Office of

Management and Budget for its review.

The regulation sections cited above

allow claimants to request application

of the published Acquiescence Ruling to

a prior determination or decision.

Claimants must demonstrate that the

application of the Acquiescence Ruling

could change the prior determination or

decision. Claimants may do so by

submitting a statement. If the claimant

can so demonstrate, the information will

be used to readjudicate the claim. Thus,

claimants, whose determinations or

decisions on their claims may be

affected by the Acquiescence Ruling,

may continue to make submissions to

the Agency regarding such claims.

We estimate that the public reporting

burden will be 17 minutes per response

for between 0 and 50,000 respondents

depending on the characteristics of the

individual AR, resulting in up to

7083.33 burden hours per AR. We

estimate there will be 3 to 4 ARs per

year. If you have any comments or

suggestions on this estimate, write to

OMB and SSA at the following

addresses:

Office of Management and Budget,

OIRA, Attn: Laura Oliven, Room

10230, New Executive Office

Building, Washington, D.C. 20503.

Social Security Administration,

DCFAM. Attn: Nicholas E. Tagliareni,

1–A–21 Operations Building, 6401

Security Blvd., Baltimore, MD 21235.

In addition to your comments on the

accuracy of the Agency’s burden

estimate, we are soliciting comments on

the need for the information; its

practical utility; ways to enhance its

quality, utility and clarity; and on ways

to minimize the time it takes for

claimants to request application of the

Acquiescence Ruling to the prior

determination, including the use of

automated collection techniques or

other forms of information technology.

(Catalog of Federal Domestic Assistance

Program Nos. 96.001, Social SecurityDisability Insurance; 96.002, Social SecurityRetirement Insurance; 96.003, Social

Security-Special Benefits for Persons Aged 72

and Over; 96.004, Social Security-Survivors

Insurance; 96.005, Special Benefits for

Disabled Coal Miners; 96.006, Supplemental

Security Income)

List of Subjects

20 CFR Part 404

Administrative practice and

procedure, Death benefits, 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,

Supplemental Security Income (SSI),

Reporting and recordkeeping

requirements.

Dated: September 11, 1997.

John J. Callahan,

Acting Commissioner of Social Security.

For the reasons set out in the

preamble, subpart J of part 404 and

subpart N of part 416 of chapter III of

title 20 of the Code of Federal

Regulations are proposed to be amended

as set forth below.

PART 404—FEDERAL OLD-AGE,

SURVIVORS AND DISABILITY

INSURANCE (1950– )

1. The authority citation for subpart J

of part 404 continues to read as follows:

Authority: Secs. 201(j), 205 (a), (b), (d)–(h),

and (j), 221, 225, and 702(a)(5) of the Social

Security Act (42 U.S.C. 401(j), 405 (a), (b),

(d)–(h), and (j), 421, 425, and 902(a)(5)); 31

U.S.C. 3720A; sec. 5, Pub. L. 97–455, 96 Stat.

2500 (42 U.S.C. 405 note); secs. 5, 6 (c)–(e),

and 15, Pub. L. 98–460, 98 Stat. 1802 (42

U.S.C. 421 note).

2. Section 404.985 is revised to read

as follows:

§ 404.985 Application of circuit court law.

The procedures which follow apply to

administrative determinations or

decisions on claims involving the

application of circuit court law.

(a) General. We will apply a holding

in a United States Court of Appeals

decision that we determine conflicts

with our interpretation of a provision of

the Social Security Act or regulations

unless the Government seeks further

judicial review of that decision or we

relitigate the issue presented in the

decision in accordance with paragraphs

(c) and (d) of this section. We will apply

the holding to claims at all levels of

administrative adjudication within the

applicable circuit unless the holding, by

its nature, applies only at certain levels

of adjudication.

(b) Issuance of an Acquiescence

Ruling. When we determine that a

United States Court of Appeals holding

conflicts with our interpretation of a

provision of the Social Security Act or

regulations and the Government does

not seek further judicial review or is

unsuccessful on further review, we will

issue a Social Security Acquiescence

Ruling. The Acquiescence Ruling will

describe the administrative case and the

court decision, identify the issue(s)

involved, and explain how we will

apply the holding, including, as

necessary, how the holding relates to

other decisions within the applicable

circuit. These Acquiescence Rulings

will generally be effective on the date of

their publication in the Federal Register
48966 Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Proposed Rules

and will apply to all determinations and

decisions made on or after that date

unless an Acquiescence Ruling is

rescinded as stated in paragraph (e) of

this section. The process we will use

when issuing an Acquiescence Ruling

follows:

(1) We will release an Acquiescence

Ruling for publication in the Federal

Register for any precedential circuit

court decision that we determine

contains a holding that conflicts with

SSA’s interpretation of a provision of

the Social Security Act or regulations no

later than 120 days from the receipt of

the court’s decision. This timeframe will

not apply when we decide to seek

further judicial review of the circuit

court decision or when coordination

with the Department of Justice and/or

other Federal agencies makes this

timeframe no longer feasible.

(2) If we make a determination or

decision on your claim between the date

of a circuit court decision and the date

we publish an Acquiescence Ruling,

you may request application of the

published Acquiescence Ruling to the

prior determination or decision. You

must demonstrate that application of the

Acquiescence Ruling could change the

prior determination or decision in your

case. You may demonstrate this by

submitting a statement that cites the

Acquiescence Ruling and indicates what

finding or statement in the prior

determination or decision conflicts with

the Acquiescence Ruling. If you can so

demonstrate, we will readjudicate the

claim at the level at which it was last

adjudicated in accordance with the

Acquiescence Ruling. Any

readjudication will be limited to

consideration of the issue(s) covered by

the Acquiescence Ruling and any new

determination or decision on

readjudication will be subject to

administrative and judicial review in

accordance with this subpart. Our

denial of a request for readjudication

will not be subject to further

administrative or judicial review. If you

file a request for readjudication within

the 60-day appeal period and we deny

that request, we shall extend the time to

file an appeal on the merits of the claim

to 60 days after the date that we deny

the request for readjudication.

(3) After we receive a precedential

circuit court decision and determine

that an Acquiescence Ruling may be

required, we will begin to identify those

claims that are pending before us within

the circuit and that might be subject to

a readjudication if an Acquiescence

Ruling is subsequently issued. When an

Acquiescence Ruling is published, we

will send notices to those individuals

whose cases we have identified which

may be affected by the Acquiescence

Ruling. The notice will provide

information about the Acquiescence

Ruling and the right to request a

readjudication under that Acquiescence

Ruling, as described in paragraph (b)(2)

of this section. It is not necessary for an

individual to receive a notice in order

to request application of an

Acquiescence Ruling to his or her claim,

as described in paragraph (b)(2) of this

section.

(c) Relitigation of court’s holding after

publication of an Acquiescence Ruling.

After we have published an

Acquiescence Ruling to reflect a holding

of a United States Court of Appeals on

an issue, we may decide under certain

conditions to relitigate that issue within

the same circuit. We will relitigate only

when the conditions specified in

paragraphs (c) (2) and (3) of this section

are met, and, in general, one of the

events specified in paragraph (c)(1) of

this section occurs.

(1) Activating events:

(i) An action by both Houses of

Congress indicates that a court case on

which an Acquiescence Ruling was

based was decided inconsistently with

congressional intent, such as may be

expressed in a joint resolution, an

appropriations restriction, or enactment

of legislation which affects a closely

analogous body of law;

(ii) A statement in a majority opinion

of the same circuit indicates that the

court might no longer follow its

previous decision if a particular issue

were presented again;

(iii) Subsequent circuit court

precedent in other circuits supports our

interpretation of the Social Security Act

or regulations on the issue(s) in

question; or

(iv) A subsequent Supreme Court

decision presents a reasonable legal

basis for questioning a circuit court

holding upon which we base an

Acquiescence Ruling.

(2) The General Counsel of the Social

Security Administration, after

consulting with the Department of

Justice, concurs that relitigation of an

issue and application of our

interpretation of the Social Security Act

or regulations at the administrative level

within the circuit would be appropriate.

(3) We publish a notice in the Federal

Register that we intend to relitigate an

Acquiescence Ruling issue and that we

will apply our interpretation of the

Social Security Act or regulations at the

administrative level within the circuit to

claims selected for relitigation. The

notice will explain why we made this

decision.

(d) Notice of relitigation. When we

decide to relitigate an issue, we will

provide a notice explaining our action

to all affected claimants. In adjudicating

claims subject to relitigation,

decisionmakers throughout the SSA

administrative review process will

apply our interpretation of the Social

Security Act and regulations, but will

also state in written determinations or

decisions how the claims would have

been decided under the circuit standard.

Claims not subject to relitigation will

continue to be decided under the

Acquiescence Ruling in accordance

with the circuit standard. So that

affected claimants can be readily

identified and any subsequent decision

of the circuit court or the Supreme

Court can be implemented quickly and

efficiently, we will maintain a listing of

all claimants who receive this notice

and will provide them with the relief

ordered by the court.

(e) Rescission of an Acquiescence

Ruling. We will rescind as obsolete an

Acquiescence Ruling and apply our

interpretation of the Social Security Act

or regulations by publishing a notice in

the Federal Register when any of the

following events occurs:

(1) The Supreme Court overrules or

limits a circuit court holding that was

the basis of an Acquiescence Ruling;

(2) A circuit court overrules or limits

itself on an issue that was the basis of

an Acquiescence Ruling;

(3) A Federal law is enacted that

removes the basis for the holding in a

decision of a circuit court that was the

subject of an Acquiescence Ruling; or

(4) We subsequently clarify, modify or

revoke the regulation or ruling that was

the subject of a circuit court holding

that we determined conflicts with our

interpretation of the Social Security Act

or regulations, or we subsequently

publish a new regulation(s) addressing

an issue(s) not previously included in

our regulations when that issue(s) was

the subject of a circuit court holding

that conflicted with our interpretation of

the Social Security Act or regulations

and that holding was not compelled by

the statute or Constitution.

PART 416—SUPPLEMENTAL

SECURITY INCOME FOR THE AGED,

BLIND, AND DISABLED

1. The authority citation for subpart N

continues to read as follows:

Authority: Sec. 702(a)(5), 1631, and 1633

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

902(a)(5), 1383, and 1383b).

2. Section 416.1485 is revised to read

as follows:

§ 416.1485 Application of circuit court law.

The procedures which follow apply to

administrative determinations or
Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Proposed Rules 48967

decisions on claims involving the

application of circuit court law.

(a) General. We will apply a holding

in a United States Court of Appeals

decision that we determine conflicts

with our interpretation of a provision of

the Social Security Act or regulations

unless the Government seeks further

judicial review of that decision or we

relitigate the issue presented in the

decision in accordance with paragraphs

(c) and (d) of this section. We will apply

the holding to claims at all levels of

administrative adjudication within the

applicable circuit unless the holding, by

its nature, applies only at certain levels

of adjudication.

(b) Issuance of an Acquiescence

Ruling. When we determine that a

United States Court of Appeals holding

conflicts with our interpretation of a

provision of the Social Security Act or

regulations and the Government does

not seek further judicial review or is

unsuccessful on further review, we will

issue a Social Security Acquiescence

Ruling. The Acquiescence Ruling will

describe the administrative case and the

court decision, identify the issue(s)

involved, and explain how we will

apply the holding, including, as

necessary, how the holding relates to

other decisions within the applicable

circuit. These Acquiescence Rulings

will generally be effective on the date of

their publication in the Federal Register

and will apply to all determinations and

decisions made on or after that date

unless an Acquiescence Ruling is

rescinded as stated in paragraph (e) of

this section. The process we will use

when issuing an Acquiescence Ruling

follows:

(1) We will release an Acquiescence

Ruling for publication in the Federal

Register for any precedential circuit

court decision that we determine

contains a holding that conflicts with

SSA’s interpretation of a provision of

the Social Security Act or regulations no

later than 120 days from the receipt of

the court’s decision. This timeframe will

not apply when we decide to seek

further judicial review of the circuit

court decision or when coordination

with the Department of Justice and/or

other Federal agencies makes this

timeframe no longer feasible.

(2) If we make a determination or

decision on your claim between the date

of a circuit court decision and the date

we publish an Acquiescence Ruling,

you may request application of the

published Acquiescence Ruling to the

prior determination or decision. You

must demonstrate that application of the

Acquiescence Ruling could change the

prior determination or decision in your

case. You may demonstrate this by

submitting a statement that cites the

Acquiescence Ruling and indicates what

finding or statement in the prior

determination or decision conflicts with

the Acquiescence Ruling. If you can so

demonstrate, we will readjudicate the

claim at the level at which it was last

adjudicated in accordance with the

Acquiescence Ruling. Any

readjudication will be limited to

consideration of the issue(s) covered by

the Acquiescence Ruling and any new

determination or decision on

readjudication will be subject to

administrative and judicial review in

accordance with this subpart. Our

denial of a request for readjudication

will not be subject to further

administrative or judicial review. If you

file a request for readjudication within

the 60-day appeal period and we deny

that request, we shall extend the time to

file an appeal on the merits of the claim

to 60 days after the date that we deny

the request for readjudication.

(3) After we receive a precedential

circuit court decision and determine

that an Acquiescence Ruling may be

required, we will begin to identify those

claims that are pending before us within

the circuit and that might be subject to

a readjudication if an Acquiescence

Ruling is subsequently issued. When an

Acquiescence Ruling is published, we

will send notices to those individuals

whose cases we have identified which

may be affected by the Acquiescence

Ruling. The notice will provide

information about the Acquiescence

Ruling and the right to request a

readjudication under that Acquiescence

Ruling, as described in paragraph (b)(2)

of this section. It is not necessary for an

individual to receive a notice in order

to request application of an

Acquiescence Ruling to his or her claim,

as described in paragraph (b)(2) of this

section.

(c) Relitigation of court’s holding after

publication of an Acquiescence Ruling.

After we have published an

Acquiescence Ruling to reflect a holding

of a United States Court of Appeals on

an issue, we may decide under certain

conditions to relitigate that issue within

the same circuit. We will relitigate only

when the conditions specified in

paragraphs (c) (2) and (3) of this section

are met, and, in general, one of the

events specified in paragraph (c)(1) of

this section occurs.

(1) Activating events:

(i) An action by both Houses of

Congress indicates that a court case on

which an Acquiescence Ruling was

based was decided inconsistently with

congressional intent, such as may be

expressed in a joint resolution, an

appropriations restriction, or enactment

of legislation which affects a closely

analogous body of law;

(ii) A statement in a majority opinion

of the same circuit indicates that the

court might no longer follow its

previous decision if a particular issue

were presented again;

(iii) Subsequent circuit court

precedent in other circuits supports our

interpretation of the Social Security Act

or regulations on the issue(s) in

question; or

(iv) A subsequent Supreme Court

decision presents a reasonable legal

basis for questioning a circuit court

holding upon which we base an

Acquiescence Ruling.

(2) The General Counsel of the Social

Security Administration, after

consulting with the Department of

Justice, concurs that relitigation of an

issue and application of our

interpretation of the Social Security Act

or regulations at the administrative level

within the circuit would be appropriate.

(3) We publish a notice in the Federal

Register that we intend to relitigate an

Acquiescence Ruling issue and that we

will apply our interpretation of the

Social Security Act or regulations at the

administrative level within the circuit to

claims selected for relitigation. The

notice will explain why we made this

decision.

(d) Notice of relitigation. When we

decide to relitigate an issue, we will

provide a notice explaining our action

to all affected claimants. In adjudicating

claims subject to relitigation,

decisionmakers throughout the SSA

administrative review process will

apply our interpretation of the Social

Security Act and regulations, but will

also state in written determinations or

decisions how the claims would have

been decided under the circuit standard.

Claims not subject to relitigation will

continue to be decided under the

Acquiescence Ruling in accordance

with the circuit standard. So that

affected claimants can be readily

identified and any subsequent decision

of the circuit court or the Supreme

Court can be implemented quickly and

efficiently, we will maintain a listing of

all claimants who receive this notice

and will provide them with the relief

ordered by the court.

(e) Rescission of an Acquiescence

Ruling. We will rescind as obsolete an

Acquiescence Ruling and apply our

interpretation of the Social Security Act

or regulations by publishing a notice in

the Federal Register when any of the

following events occurs:

(1) The Supreme Court overrules or

limits a circuit court holding that was

the basis of an Acquiescence Ruling;
48968 Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Proposed Rules

(2) A circuit court overrules or limits

itself on an issue that was the basis of

an Acquiescence Ruling;

(3) A Federal law is enacted that

removes the basis for the holding in a

decision of a circuit court that was the

subject of an Acquiescence Ruling; or

(4) We subsequently clarify, modify or

revoke the regulation or ruling that was

the subject of a circuit court holding

that we determined conflicts with our

interpretation of the Social Security Act

or regulations, or we subsequently

publish a new regulation(s) addressing

an issue(s) not previously included in

our regulations when that issue(s) was

the subject of a circuit court holding

that conflicted with our interpretation of

the Social Security Act or regulations

and that holding was not compelled by

the statute or Constitution.

[FR Doc. 97–24803 Filed 9–17–97; 8:45 am]

BILLING CODE 4190–11–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 111

[Docket No. 95N–0304]

RIN 0901–AA59

Dietary Supplements Containing

Ephedrine Alkaloids; Reopening of

Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; reopening of

comment period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening from

September 18, 1997, to December 2,

1997, the comment period on the

proposed rule on dietary supplements

containing ephedrine alkaloids that was

published in the Federal Register of

June 4, 1997 (62 FR 30678). This action

is being taken to provide a renewed

opportunity for public comment after

the agency has rectified a number of

inadvertent omissions from the

administrative record. FDA is also

providing an opportunity for comment

on adverse event reports (AER’s) that

FDA has received since January 1997

and on new analytical data that FDA is

adding to the administrative record.

Finally, FDA is reopening the comment

period in response to several requests

for extensions of the comment period to

permit interested persons to submit new

scientific data.

DATES: Written comments by December

2, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), 12420 Parklawn Dr., rm. 1–

23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Margaret C. Binzer, Center for Food

Safety and Applied Nutrition (HFS–

456), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–401–9859, FAX 202–260–8957 or

E-mail ‘‘MBinzer @Bangate.fda.gov’’.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 4, 1997, FDA

published a proposed rule regarding the

formulation and labeling of dietary

supplements containing ephedrine

alkaloids. FDA proposed this rule in

response to serious illnesses and

injuries, including multiple deaths,

associated with the use of dietary

supplement products that contain

ephedrine alkaloids and in response to

the agency’s investigations and analyses

of these illnesses and injuries. Interested

persons were given until August 18,

1997, to comment on the proposal.

In the Federal Register of August 20,

1997 (62 FR 44247), FDA announced

that it would reopen the comment

period for the proposed rule because the

agency had identified a number of

inadvertent omissions (i.e., missing

pages in several of the AER’s and other

minor problems) in the administrative

record. FDA has reviewed each of the

AER’s to rectify these omissions, which

included: Missing product labels or

labeling, affidavits from consumers or

health care professionals, investigator

followup reports, and individual pages

from medical records. FDA has recopied

each of the AER files and placed them

on display at the Dockets Management

Branch. Any followup materials that the

agency received after the AER’s were

made part of the administrative record

for this rulemaking in June 1997 are

now included in the corresponding

AER. For convenience to the users of the

administrative record, the agency has

also organized the duplicate AER files to

make it easier to locate them in the

record.

As of January 1997, FDA had received

over 800 reports of adverse events

associated with the use of more than

100 different dietary supplements that

contained, or were suspected of

containing, ephedrine alkaloids. Since

that time, FDA has continued to receive

additional AER’s associated with the

use of these products. FDA is adding the

AER’s that it received between January

and August 1997 to supplement the

administrative record. These documents

are filed in the administrative record

under the title: ‘‘AER’s Associated with

the Use of Dietary Supplements

Containing Ephedrine Alkaloids that

FDA has Received Since the Preparation

of the Docket Submission of January 17,

1997.’’

Since the time that the proposal was

published, FDA has received the results

of chemical analyses for several of the

dietary supplement products associated

with AER’s. When an adverse event

appears to be clinically significant, FDA

routinely requests from the consumer a

sample of the remaining portion of the

product related to the AER and has its

laboratories analyze the sample. These

analytical results provide

supplementary data on levels of

ephedrine alkaloids in the dietary

supplements. FDA is adding these

analytical results to the administrative

record. A summary of these analytical

results are filed in the administrative

record under the title: ‘‘Analytical

Results of Ephedrine AlkaloidContaining Dietary Supplements

Associated With Adverse Events,

August 1997.’’ These documents will be

placed on display in the Dockets

Management Branch along with the rest

of the administrative record that FDA

has compiled to date.

In addition, FDA has received several

requests for extensions of the comment

period. These requests stated as grounds

for an extension, among other things,

that there is a need for additional time

to review the clinical data and other

information in the administrative record

and to submit new scientific data to the

agency. Several requests were for

extensions of 180 days.

Having carefully considered these

requests and given the fact that it has

added material to the administrative

record, the agency has decided to

reopen the comment period until

December 2, 1997. The reopening of the

comment period will provide interested

persons with a significant amount of

additional time to evaluate all the

information in the administrative record

that underlies the proposal that FDA

published in June 1997 and to formulate

any comments that they deem

appropriate. The agency particularly

encourages small businesses to take

advantage of this additional opportunity

to participate in the regulatory process.

Because of the serious and significant

adverse events associated with the use

of dietary supplements containing

ephedrine alkaloids, FDA is concerned

about the adverse impact that a

prolonged comment period may have on

the public health. For this reason, the

agency decided not to grant the requests

for an additional comment period longer

than 75 days. The agency’s decision to

reopen the comment period for 75 days

balances the needs of interested persons