14918 Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Proposed Rules

exempted from any or all provisions of

this subpart.

* * * * *

Dated: March 15, 1995.

Lon Hatamiya,

Administrator.

[FR Doc. 95–6909 Filed 3–20–95; 8:45 am]

BILLING CODE 3410–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101, 111, 170, and 310

[Docket Nos. 91P–0186 and 93P–0306]

Acute Toxicity of Elemental (Reduced,

Metallic Powder) Forms of Iron

Relative to That of Iron Salts; Notice of

a Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public workshop.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public workshop on the acute toxicity of

elemental (reduced, metallic powder)

forms of iron. The purpose of this

workshop is to solicit scientific data and

information from interested persons

about the acute toxicity of elemental

forms of iron with regard to whether

such forms are sufficiently safe in

dietary supplement and drug products

to warrant exemption from the special

packaging and labeling requirements

that FDA has proposed for products

containing iron salts.

DATES: The public workshop will be

held on April 20, 1995, 8:30 a.m. to 5

p.m. Submit written comments by April

20, 1995.

ADDRESSES: The public workshop will

be held at the Parklawn Bldg.,

conference room G, 5600 Fishers Lane,

Rockville, MD 20857. Written comments

regarding the workshop may be

submitted to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John

N. Hathcock, Center for Food Safety and

Applied Nutrition (HFS–465), Food and

Drug Administration, 8301 Muirkirk

Rd., Laurel, MD 20708, 301–594–6006.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 6, 1994 (59

FR 51030), FDA issued a proposal (the

initial proposal) on actions that it

tentatively concluded were necessary to

stem the recent epidemic of pediatric

poisonings from over-consuming ironcontaining products. In the Federal

Register of February 16, 1995 (60 FR

8989), the agency issued a

supplementary proposal to clarify

changes in its legal authority with the

passage of the Dietary Supplement

Health and Education Act (Pub. L. 103–

417).

In the initial proposal, FDA briefly

described the three basic types of

elemental iron powders that are

marketed for use in foods. The three

types are reduced iron, electrolytic iron,

and carbonyl iron. The term ‘‘carbonyl’’

refers to the production process, not the

composition of the product. The

bioavailability of these various

elemental iron sources is dependent

primarily on their physical

characteristics, which in turn depend on

the manufacturing method. For

example, higher relative

bioavailabilities of elemental iron are

obtained with smaller particle sizes.

Some evidence suggests that carbonyl

iron may be a useful substitute for the

more commonly used chemical

compounds of iron in reducing the risk

of accidental iron poisonings. Data from

studies in animals suggest that carbonyl

iron may be only 1/100th as toxic as

ferrous sulfate in single doses, i.e., the

LD50 (lethal dose for 50 percent of the

test group) of ferrous sulfate is

approximately 0.30 gram ferrous per

kilogram (g Fe/kg) (The Merck Index,

11th ed., p. 635 (1989)), and the LD50 for

carbonyl iron is approximately 30.0 g

Fe/kg body weight. At the same time,

data from human subjects indicate that

the overall bioavailability of carbonyl

iron in supporting the nutritional

functions of iron is about 70 percent

that of ferrous sulfate. Thus, carbonyl

iron, in comparison with ferrous sulfate,

appears to have a much larger margin of

safety between the level that would

provide adequate iron nutrition and the

level that causes acute toxicity.

Consequently, carbonyl iron may be

inherently safer to use, and its use may

help to reduce the risk of iron poisoning

in children, than ferrous sulfate.

In the initial proposal, FDA expressed

interest in receiving data on the

potential of elemental iron to have acute

toxicity in humans, and particularly in

children, and stated that the agency

would carefully consider any

information that it received on this

subject. FDA stated that, if the

information it received was persuasive

in establishing that the use of elemental

iron would substantially decrease the

risk of pediatric poisoning while

allowing for effective dietary iron

supplementation, FDA would consider

exempting iron-containing products that

incorporate elemental iron from any

regulations that result from this

rulemaking.

In response to this request for

information, FDA received several

comments that supplied information on

this topic. Some of the comments

included citations to scientific literature

or copies of scientific articles. The

comments argued that the information

supports an exemption of products

formulated with elemental iron from the

labeling and packaging requirements

applied to products containing iron

salts. These comments have convinced

FDA that the issues and data that they

have presented should be discussed in

a public workshop.

The purpose of the workshop on the

acute toxicity of elemental iron is to:

1. Identify data that objectively

describe the acute toxicity of elemental

iron.

2. Identify the market uses of

elemental iron and any adverse reaction

reporting systems or processes used by

manufacturers and vendors.

3. Identify any data on acute,

accidental exposure of children or

adults to products containing elemental

iron.

4. Discuss a possible conceptual

framework for evaluation of the effects

of elemental forms of iron upon acute

exposure.

5. Discuss the validity, and

limitations, of acute toxicity data in

experimental animals in predicting the

risk in young children.

Specific topics that may be relevant

and on which discussion is invited

include:

1. Physiological factors that influence

acute toxicity of elemental forms of iron,

in comparison with those for iron salts.

2. The quality, results, and relevance

of animal studies on acute toxicity of

elemental iron and iron salts.

3. The quality and results of human

studies for evaluating the effects of

elemental iron.

4. Factors influencing the validity of

extrapolation of experimental animal

data on acute toxicity of various forms

of iron for predicting the risk in young

children.

5. Current uses of elemental iron in

dietary supplements and drugs and the

data available on potential adverse

effects.

Discussion of these topics will be

considered by FDA in the development

of any final rule on the packaging and

labeling of products containing iron

salts. In conjunction with the workshop,

FDA specifically requests comments on

the appropriateness of elemental iron as

a source of iron in drugs and dietary

supplements. The comments should

focus on whether the use of elemental
Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Proposed Rules 14919

iron in iron-containing products will

decrease the risk of pediatric

poisonings, while providing desirable

iron nutrition to those who need iron

supplementation, and on whether an

exemption for products that contain

elemental iron from any packaging and

labeling requirements that result from

the underlying rulemaking is

appropriate.

Interested persons may on or before

April 20, 1995, submit to the Dockets

Management Branch (address above)

comments on the workshop. Additional

written comments may be submitted for

30 days after the date of this workshop.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Written comments and

submitted documents are to be

identified with the docket numbers

found in brackets in the heading of this

document. Received comments and the

transcript of the discussion identified

with the same docket numbers may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: March 16, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–6919 Filed 3–20–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[DoD 6010.8–R]

RIN 0720–AA26

Civilian Health and Medical Program of

the Uniformed Services (CHAMPUS);

Six Separate Changes

AGENCY: Office of the Secretary, DoD.

ACTION: Proposed rule.

SUMMARY: This proposed rule addresses

six separate changes to comply with

new statutory provisions affecting

CHAMPUS. These changes will update

this part to include as a benefit, a screen

to check for the level of lead in the

blood of an infant; eliminate the implied

statement that ambulance services are

covered only to and from hospitals;

include other forms of prescribed

contraceptives by eliminating the

reference that limits prescribed

contraceptives only to those taken

orally; recognize chemical aversion

therapy as a treatment modality for

alcoholism by eliminating the

exclusionary language in the current

regulation; identify three additional

Gulf Conflict groups eligible for the

delay in the increased deductible; and

to establish lower limits on the fiscal

year catastrophic cap from $10,000 to

$7,500 for all eligibles except

dependents of active duty personnel,

whose limit remains at $1,000.

DATES: Written comments, whether from

the general public or from other

governmental agencies, must be

received on or before May 22, 1995.

ADDRESSES: Office of the Civilian Health

and Medical Program of the Uniformed

Services (OCHAMPUS), Program

Development Branch, Aurora, Co

80045–6900.

FOR FURTHER INFORMATION CONTACT:

Mr. A. Chris Armijo, Program

Development Branch, OCHAMPUS,

telephone (303) 361–1120.

SUPPLEMENTARY INFORMATION: 32 CFR

199.4 lists Basic Program benefits

including exclusions and limitations.

Paragraph (c) defines, in general terms,

the scope of reimbursable services

provided by physicians and other

authorized individual professional

providers; paragraph (e) extends

benefits under certain circumstances, to

conditions and limitations that are

subject to applicable definitions,

conditions, or exclusions that are set

forth in this or other sections of this

regulation; paragraph (f) identifies the

liabilities, in the form of cost-shares and

deductibles, to be paid by beneficiaries

or sponsors.

Well-Baby Care: Paragraph (c)(3)(xi),

provides for certain well-baby care

services for infants up to the age of two

years. A paragraph (6) will be added

under paragraph (xi)(A) to list blood

lead level screening for infants as a

benefit.

Ambulance Service: Ambulance

services are covered between points

deemed to be medically necessary for

the covered medical condition,

therefore, the restrictive language, ‘‘to,

from, and between hospitals’’ will be

removed from paragraph (d)(3)(v).

Family Planning: Paragraph (e)(3)

provides for a family planning benefit.

Paragraph (e)(3)(i)(A)(3) of this Section

allows benefits for prescribed oral

contraceptives. With the development of

new methods of contraception,

prescribed contraceptives are no longer

limited to those taken orally. We are,

therefore, amending that paragraph by

removing the word ‘‘oral’’ to expand the

coverage accordingly.

Treatment for Alcoholism: Paragraph

(e)(4)(iii)(A) of § 199.4, has historically

excluded benefits for aversion therapy

as a treatment modality for alcoholism.

At the request of OCHAMPUS, the

Office of Health Technology Assessment

(OHTA) of the Public Health Service

(PHS) conducted an assessment of the

safety and efficacy of chemical aversion

conditioning for the treatment of

alcoholism. On the basis of the OHTA

assessment, it was determined that

chemical aversion conditioning is no

less effective than other therapies for

alcoholism when it is provided

following the failure of less intrusive

therapies. This rule proposes to remove

paragraph (e)(4)(iii)(A) in its entirety to

remove exclusionary language, to

reserve that paragraph for future use,

and to revise paragraph (4)(ii), to

include coverage of chemical aversion

therapy as a treatment modality.

Financial Liability-Deductibles: Under

paragraph (f) of section 199.4,

CHAMPUS beneficiaries and sponsors

have some financial responsibility when

medical care is received from civilian

sources. Financial liability is imposed

in order to encourage use of the

Uniformed Services direct medical care

system whenever facilities and services

are available. Beneficiaries are

responsible for payment of certain

deductible and cost-sharing amounts in

connection with otherwise covered

services and supplies. The cost-share

and deductible amounts are controlled

by statute and subject to change by

Congressional action. Previous

legislation had deferred a statutory

increase in the deductible amount from

April 1, 1991, to October 1, 1991, for

dependents of active duty members who

served in the Gulf Conflict. The

National Defense Authorization Act for

Fiscal Year 1993 contains language

which prompts a revision of paragraph

(f)(2)(i)(G) of this section to identify

three new groups of Gulf Conflict

beneficiaries, besides the dependents of

active duty members, eligible for the

delay in the increased deductibles, and

to allow credit or reimbursement of

excess amounts inadvertently paid by

those groups subject to availability of

appropriated funds.

Catastrophic Loss: The National

Defense Authorization Act for Fiscal

Years 1988 and 1989 (P.L. 100–180)

amended Title 10, United States Code

and established catastrophic loss

protection for CHAMPUS beneficiaries

on a government fiscal year basis. The

law placed fiscal year limits or,

catastrophic caps, on beneficiary

liability for cost-shares and deductibles

under the CHAMPUS Basic Program.

After the fiscal year cap is met by the

beneficiary, the CHAMPUS determined

allowable amounts for all covered

services or supplies received under the

Basic Program are to be paid in full by

CHAMPUS.

For dependents of active duty

members, the maximum family liability