Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Proposed Rules 32159

No. 11–2A which describes the

application procedure.

The Proposal

The FAA proposes to amend 14 CFR

part 71 by revising the Class E airspace

at Unalakleet, AK, due the

establishment of a GPS instrument

approach to RWY 14. The intended

effect of this proposal is to provide

adequate controlled airspace for

Instrument Flight Rules (IFR) operations

at Unalakleet, AK.

The area would be depicted on

aeronautical charts for pilot reference.

The coordinates for this airspace docket

are based on North American Datum 83.

The Class E airspace areas designated as

an 700/1200 foot transition area are

published in paragraph 6005 in FAA

Order 7400.9E, Airspace Designations

and Reporting Points, dated September

10, 1997, and effective September 16,

1997, which is incorporated by

reference in 14 CFR 71.1 (62 FR 52491;

October 8, 1997). The Class E airspace

listed in this document would be

revised and published in the Order.

The FAA has determined that these

proposed regulations only involve an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current. It,

therefore—(1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under DOT Regulatory Policies

and Procedures (44 FR 11034; February

26, 1979); and (3) does not warrant

preparation of a regulatory evaluation as

the anticipated impact is so minimal.

Since this is a routine matter that will

only affect air traffic procedures and air

navigation, it is certified that this rule,

when promulgated, will not have a

significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 71 as

follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for 14 CFR

part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is to be amended

as follows:

Paragraph 6005 Class E airspace extending

upward from 700 feet or more above the

surface of the earth.

* * * * *

AAL AK E5 Unalakleet, AK

Unalakleet Airport, AK

(Lat. 63°53′18′′N., long. 160°47′56′′W.)

Unalakleet VORTAC

(Lat. 63°53′31′′N., long. 160°41′04′′W.)

Unalakleet Localizer

(Lat. 63°52′52′′N., long. 160°47′42′′W.)

That airspace extending upward from 700

feet above the surface within a 6.7-mile

radius of the Unalakleet Airport and within

2 miles each side of the 289° radial of the

Unalakleet VORTAC extending from the 6.7-

mile radius to 14.1 miles west of the

VORTAC and within 3 miles east and 3 miles

west of the Unalakleet Localizer front course

extending from the 6.7-mile radius to 12.9

miles north of the airport; and that airspace

extending upward from 1,200 feet above the

surface within a 22-mile radius of the

Unalakleet VORTAC extending clockwise

from the 165° radial to the 322° radial and

within 4 miles east and 8 miles west of the

Unalakleet Localizer front course extending

from the Localizer to 22 miles north of the

airport and within 4 miles north and 8 miles

south of the Unalakleet VORTAC 289° radial

extending from the VORTAC to 27 miles west

of the VORTAC.

* * * * *

Issued in Anchorage, AK, on June 4, 1998.

Willis C. Nelson,

Manager, Air Traffic Division, Alaskan

Region.

[FR Doc. 98–15714 Filed 6–11–98; 8:45 am]

BILLING CODE 4910–13–U

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1700

Poison Prevention Packaging

Requirements; Proposed Exemption of

Sucraid

AGENCY: Consumer Product Safety

Commission.

ACTION: Proposed rule.

SUMMARY: The Commission is proposing

to exempt from its child-resistant

packaging requirements the oral

prescription drug Sucraid. Sucraid is a

new liquid formulation of sacrosidase, a

yeast derived form of the sucrase

enzyme, used for the treatment of

congenital sucrase-isomaltase

deficiency. The Commission proposes

this exemption because human

experience has shown no evidence of

serious toxicity.

DATES: Comments on the proposal

should be submitted no later than

August 26, 1998.

ADDRESSES: Comments should be

mailed to the Office of the Secretary,

Consumer Product Safety Commission,

Washington, D.C. 20207, or delivered to

the Office of the Secretary, Consumer

Product Safety Commission, Room 502,

4330 East-West Highway, Bethesda,

Maryland 20814–4408, telephone (301)

504–0800. Comments may also be filed

by telefacsimile to (301) 504–0127 or by

email to cpsc-os@cpsc.gov.

FOR FURTHER INFORMATION CONTACT:

Jacqueline Ferrante, Ph.D., Division of

Health Sciences, Directorate for

Epidemiology and Health Sciences,

Consumer Product Safety Commission,

Washington, D.C. 20207; telephone

(301) 504–0477 ext. 1199.

SUPPLEMENTARY INFORMATION:

A. Background

The Poison Prevention Packaging Act

of 1970 (‘‘PPPA’’), 15 U.S.C. 1471–1476,

provides the Commission with authority

to establish standards for the ‘‘special

packaging’’ of household substances,

such as drugs, when child resistant

packaging is necessary to protect

children from serious personal injury or

illness due to the substance and the

special packaging is technically feasible,

practicable, and appropriate for such

substance. Accordingly, the

Commission requires that oral

prescription drugs be in child resistant

(‘‘CR’’) packaging. 16 CFR

1700.14(a)(10).

The Commission’s regulations allow

companies to petition the Commission

for exemption from CR requirements. 16

CFR Part 1702. Possible grounds for

granting the exemption are that:

(a) The degree or nature of the hazard to

children in the availability of the substance,

by reason of its packaging, is such that

special packaging is not required to protect

children from serious personal injury or

serious illness resulting from handling, using

or ingesting the substance, or

(b) Special packaging is not technically

feasible, practicable, or appropriate for the

subject substance, or

(c) Special packaging is incompatible with

the particular substance.16 CFR 1702.17.

On July 10, 1997, Orphan Medical,

Inc. (‘‘Orphan Medical’’) petitioned the

Commission to exempt its product,

Sucraid, from the special packaging
32160 Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Proposed Rules

requirements for oral prescription drugs.

The petitioner stated that the exemption

is justified because of lack of toxicity

and lack of adverse human experience

with the drug. The petitioner also stated

that CR packaging is not technically

feasible, practicable and appropriate for

Sucraid. Because, as explained below,

the Commission concludes that Sucraid

lacks sufficient toxicity to justify special

packaging, the Commission did not

consider the technical feasibility,

practicability, and appropriateness of

special packaging for Sucraid.

Sucraid is a liquid formulation of

sacrosidase, a yeast derived form of the

sucrase enzyme. It is used to treat

patients with congenital sucraseisomaltase deficiency (‘‘CSID’’). The

petitioner estimates that there are

approximately 3000 to 10,000 cases of

CSID in the United States. CSID is a

condition characterized by absent or

low levels of sucrase and isomaltase,

two enzymes in the small intestine.

Sucrase breaks down sucrose (table

sugar) so that it can be absorbed.

Persons with CSID have such symptoms

as diarrhea, abdominal pain, bloating,

and gas. Patients with severe CSID may

require hospitalization for diarrhea,

dehydration, malnutrition, weakness

and muscle wasting. Sacrosidase is an

enzyme replacement therapy that

reduces the symptoms of CSID.

B. Toxicity Data

Sacrosidase is derived from bakers

yeast. It is Generally Recognized as Safe

(‘‘GRAS’’) for use in food by the Food

and Drug Administration (‘‘FDA’’). 21

CFR 170.30. Sucraid contains about 1.5

milligrams per milliliter of the enzyme

in a 50:50 solution of glycerol and

water.

One bottle of Sucraid contains 150 mg

of protein, 59 ml of water and 59 ml of

glycerol. Similar to dietary proteins, the

protein component of Sucraid is

digested to amino acids which are used

to make new protein and are not

expected to cause toxicity. Glycerol is a

sweet liquid used as a solvent,

preservative, and moisturizer. FDA

recognizes glycerol as GRAS for use as

a food. 21 CFR 182.1320. It is also used

as a drug, for example, to reduce

intraocular and intracranial pressure. It

also can be used as a laxative.

Possible adverse effects associated

with glycerol include nausea, vomiting,

headache, and dehydration. Less

commonly reported effects include

diarrhea, thirst, dizziness, and mental

confusion. Some more serious effects

have been reported with intravenous

administration of glycerol and with

certain high risk patients. However, the

Hazardous Chemicals Desk Reference

indicates that glycerol is only mildly

toxic by ingestion. In addition, the

Handbook of Common Poisonings in

Children characterizes glycerol as a

laxative, stating that ‘‘acute exposure to

most laxatives produces nausea,

vomiting, and diarrhea, which are

usually mild and self-limiting.’’

The CPSC staff found three cases in

the National Electronic Injury

Surveillance System (‘‘NEISS’’) of

children under five years old ingesting

products containing glycerol. The

products involved were a glycerol

suppository, a baby enema preparation,

and an ear solution. In all three cases

the child was treated and released or

examined and released without

treatment.

Thus, based on the information

discussed above, the glycerol

component of Sucraid is not likely to

cause significant toxicity to children.

C. Human Experience Data

According to the petitioner, there

have been three clinical trials of

Sucraid, two of which are complete. The

clinical investigators conducting the

trials did not rate any of the adverse

effects encountered as probably or

definitely related to the drug. Some

effects were considered to be possibly

related to the drug.

The investigators considered most of

the adverse effects to be unrelated to

Sucraid and due to illnesses common to

children (e.g., flu, ear infection and

strep throat). Unrelated effects included

sore throat, fever, cough, runny nose,

diarrhea, cramping and abdominal pain.

The clinical investigator did rate some

adverse events in the second trial as

possibly related to Sucraid. These

symptoms included abdominal pain,

diarrhea, nausea, vomiting,

constipation, dehydration, cramps,

headache, insomnia, nervousness, and

wheezing. The petitioner noted that

many of these were gastrointestinal

symptoms typical of CSID. Thus, the

dose of Sucraid given may not have

been adequate to alleviate all symptoms

of the disease. An asthmatic child had

an acute hypersensitivity reaction

(wheezing) to Sucraid that resolved

without sequelae. This patient was

withdrawn from the trial.

D. Action on the Petition

After considering the information

provided by the petitioner and other

available toxicity and human experience

data, the Commission preliminarily

concludes that the degree and nature of

the hazard to children presented by the

availability of Sucraid do not require

special packaging to protect children

from serious personal injury or serious

illness resulting from handling, using,

or ingesting the substance. Therefore,

the Commission voted to grant the

petition and begin a rulemaking

proceeding to exempt Sucraid from the

special packaging requirements for oral

prescription drugs.

E. Regulatory Flexibility Act

Certification

Under the Regulatory Flexibility Act,

5 U.S.C. 601 et seq., an agency that

engages in rulemaking generally must

prepare proposed and final regulatory

flexibility analyses describing the

impact of the rule on small businesses

and other small entities. Section 605 of

the Act provides that an agency is not

required to prepare a regulatory

flexibility analysis if the head of an

agency certifies that the rule will not

have a significant economic impact on

a substantial number of small entities.

The Commission’s Directorate for

Economic Analysis prepared a

preliminary assessment of the impact of

a rule to exempt Sucraid from special

packaging requirements. The staff

reports that because of the small number

of cases of CSID (3,000 to 10,000 in the

U.S.), the market for Sucraid is expected

to be small. The petitioner, Orphan

Medical, is a small manufacturer based

on its employment and sales. Orphan

Medical has marketing exclusivity for

Sucraid for seven years. The exemption

from special packaging requirements

will allow the company to avoid costs

associated with obtaining CR packaging.

Based on this assessment, the

Commission preliminarily concludes

that the proposed amendment

exempting Sucraid from special

packaging requirements would not have

a significant impact on a substantial

number of small businesses or other

small entities.

F. Environmental Considerations

Pursuant to the National

Environmental Policy Act, and in

accordance with the Council on

Environmental Quality regulations and

CPSC procedures for environmental

review, the Commission has assessed

the possible environmental effects

associated with the proposed PPPA

amendment.

The Commission’s regulations state

that rules requiring special packaging

for consumer products normally have

little or no potential for affecting the

human environment. 16 CFR

1021.5(c)(3). Nothing in this proposed

rule alters that expectation. (3)

Therefore, because the rule would have

no adverse effect on the environment,

neither an environmental assessment
Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Proposed Rules 32161

nor an environmental impact statement

is required.

G. Executive Orders

According to Executive Order 12988

(February 5, 1996), agencies must state

in clear language the preemptive effect,

if any, of new regulations.

The PPPA provides that, generally,

when a special packaging standard

issued under the PPPA is in effect, ‘‘no

State or political subdivision thereof

shall have any authority either to

establish or continue in effect, with

respect to such household substance,

any standard for special packaging (and

any exemption therefrom and

requirement related thereto) which is

not identical to the [PPPA] standard.’’

15 U.S.C. 1476(a). A State or local

standard may be excepted from this

preemptive effect if (1) the State or local

standard provides a higher degree of

protection from the risk of injury or

illness than the PPPA standard; and (2)

the State or political subdivision applies

to the Commission for an exemption

from the PPPA’s preemption clause and

the Commission grants the exemption

through a process specified at 16 CFR

Part 1061. 15 U.S.C. 1476(c)(1). In

addition, the Federal government, or a

State or local government, may establish

and continue in effect a non-identical

special packaging requirement that

provides a higher degree of protection

than the PPPA requirement for a

household substance for the Federal,

State or local government’s own use. 15

U.S.C. 1476(b).

Thus, with the exceptions noted

above, the proposed rule exempting

Sucraid from special packaging

requirements would preempt nonidentical state or local special packaging

standards for the substance.

In accordance with Executive Order

12612 (October 26, 1987), the

Commission certifies that the proposed

rule does not have sufficient

implications for federalism to warrant a

Federalism Assessment.

List of Subjects in 16 CFR Part 1700

Consumer protection, Drugs, Infants

and children, Packaging and containers,

Poison prevention, Toxic substances.

For the reasons given above, the

Commission proposes to amend 16 CFR

part 1700 as follows:

PART 1700—[AMENDED]

1. The authority citation for part 1700

continues to read as follows:

Authority: Pub. L. 91–601, secs. 1–9, 84

Stat. 1670–74, 15 U.S.C. 1471–76. Secs

1700.1 and 1700.14 also issued under Pub. L.

92–573, sec. 30(a), 88 Stat. 1231. 15 U.S.C.

2079(a).

2. Section 1700.14 is amended by

republishing paragraph (a) introductory

text and paragraph (a)(10) introductory

text, and by adding new paragraph

(a)(10)(xx) to read as follows:

§ 1700.14 Substances requiring special

packaging.

(a) Substances. The Commission has

determined that the degree or nature of

the hazard to children in the availability

of the following substances, by reason of

their packaging, is such that special

packaging meeting the requirements of

§ 1700.20(a) is required to protect

children from serious personal injury or

serious illness resulting from handling,

using, or ingesting such substances, and

the special packaging herein required is

technically feasible, practicable, and

appropriate for these substances:

* * * * *

(10) Prescription Drugs. Any drug for

human use that is in a dosage form

intended for oral administration and

that is required by Federal law to be

dispensed only by or upon an oral or

written prescription of a practitioner

licensed by law to administer such drug

shall be packaged in accordance with

the provisions of § 1700.15 (a), (b), and

(c), except for the following:

* * * * *

(xx) Sacrosidase (sucrase)

preparations in a solution of glycerol

and water.

Dated: June 4, 1998.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

List of Relevant Documents

1. Briefing memorandum from Jaqueline

Ferrante, Ph.D., EH, to the Commission,

‘‘Petition (PP 97–1) to Exempt Sucraid from

the Special Packaging Requirements for Oral

Prescription Drugs,’’ May 20, 1998.

2. Memorandum from Jaqueline Ferrante,

Ph.D., EH, to Mary Ann Danello, Ph.D.,

Associate Executive Director, EH, ‘‘Sucraid

Review’’ April 1, 1998.

3. Memorandum from Marcia P. Robins,

EC, to Jacqueline Ferrante, Ph.D., EH,

‘‘Economic Considerations: Petition for

Exemption from PPPA Requirements for Oral

Prescription Drug Sucraid,’’ April 2, 1998.

[FR Doc. 98–15493 Filed 6–11–98; 8:45 am]

BILLING CODE 6355–01–P

SOCIAL SECURITY ADMINISTRATION

20 CFR Part 416

RIN 0960–AE77

Denial of Supplemental Security

Income Benefits for Fugitive Felons

and Probation and Parole Violators

AGENCY: Social Security Administration.

ACTION: Proposed rules.

SUMMARY: These proposed regulations

would change our rules to reflect an

amendment to the Social Security Act

(the Act) made by Public Law 104–193,

the Personal Responsibility and Work

Opportunity Reconciliation Act of 1996.

The amendment prohibits payment of

Supplemental Security Income (SSI)

benefits to certain fugitives and

probation and parole violators.

DATES: To be sure that your comments

are considered, we must receive them

no later than August 11, 1998.

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 Office of Process and Innovation

Management, Social Security

Administration, L2109 West Low Rise,

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:

Teresa Robinson, Policy Analyst, Office

of Program Benefits Policy, Social

Security Administration, 6401 Security

Boulevard, Baltimore, MD 21235, (410)

965–7960 for information about these

rules. For information on eligibility or

claiming benefits, call our national tollfree number, 1–800–772–1213.

SUPPLEMENTARY INFORMATION:

Background

Section 202(a) of Public Law 104–193

added section 1611(e)(5) of the Act to

preclude eligibility for SSI benefits for

certain fugitives and probation and

parole violators. In general, section

1611(e)(5) of the Act provides that a

person shall not be considered an

eligible individual or eligible spouse for

purposes of the SSI program for any

month during which the person is—

• Fleeing to avoid prosecution for a

crime, or an attempt to commit a crime,

which is a felony under the laws of the

place from which the person flees (or

which, in the case of the State of New

Jersey, is a high misdemeanor under the

laws of that State);

• Fleeing to avoid custody or

confinement after conviction for a

crime, or an attempt to commit a crime,

which is a felony under the laws of the

place from which the person flees (or

which, in the case of the State of New

Jersey, is a high misdemeanor under the

laws of that State); or