Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Proposed Rules 45767

3. Article 2—Water Resources Program

No proposed revisions to this article

are recommended at this time.

4. Article 3—Project Review Under

Section 3.8 of the Compact

(a) The proposed revisions to Article

3 relating to environmental reviews and

non-substantial projects are discussed

above.

(b) The proposed revision would

delete Section 2–3.5.1. The

regionalization policy was slightly

modified with the adoption of revised

Water Quality Regulations in December

1992 (Section 2.30, Basin Regulation—

Water Quality). Deleting these

requirements eliminates confusion and

allows the more recent and flexible

policy to control. The revised rule

would add (6) in Section 2.1.4 requiring

applications to include a discussion of

the alternates considered and in Section

2.3.8 (a) ‘‘Exhibits to Accompany

Application’’, it would revise (8) to

include analysis and conclusions of

regional water supply and waste water

investigations.

(c) The proposed revision would also

delete Section 2.3.5.2. This policy was

adopted in 1971, Resolution No. 71–3,

when the DRBC was involved in four or

five nuclear plants and several major

expansions or new fossil fuel plants, all

by the seven major electric utilities

serving the Basin. Planning at that time

centered around mega stations of 1000

to 3000 Megawatts and use of multi

MGD of water. Future locations of such

large single use water demands was

essential for any future water resource

planning. A consortium of the utilities

was formed known as DRBEUG

(Delaware River Basin Electric Utilities

Group) to address this DRBC

requirement. Between 1971 and 1989,

periodic siting studies were submitted

to DRBC. In 1989 DRBEUG explained

that they no longer could present a

comprehensive siting study since the

regulators were now encouraging NUGs

(Non Utility Generators) and they could

not in any way appear to represent these

non-utility electric generators.

Essentially, the major utilities have

abandoned plans for any new major

stations. New applications for several

years now have been non-utility projects

and generally no more than 200 MW.

After several meetings between

DRBEUG and staff, it was concluded

that the siting study would no longer

serve its intended purpose for DRBC.

(d) The remaining sections are

intended to clarify the Commission’s

procedures with regard to Section 3.8

applications and the review thereof.

5. Article 4—Environmental Impact

Statements

The Commission proposes deletion of

the existing provisions of Article 4 as

discussed above. Article 4 will be

reserved for future use.

6. Article 5—Review in Water Quality

Cases

The proposed revisions to Article 5

clarify that this article applies to

administrative actions and decisions by

the Executive Director. The procedures

for review, hearing and decisions of

objections to the Executive Director’s

actions and decisions will be pursuant

to Article 6. The time for requesting a

hearing is extended to thirty days to

conform with the thirty day period

provided for in Article 6. The remaining

proposed changes are to broaden the

wasteload allocations section to cover

allocations in general (including

proposed allocations of toxics) as well

as the existing allocation program of

carbonaceous oxygen demand.

7. Article 6—Conduct of Hearings

The proposed revisions in this article

reflect the practices employed by the

Commission in connection with

hearings, clarify the application of

Article 6 to contested hearings and

codify existing practices with regard to

such hearings.

8. Articles 7, 8 and 9

No changes to these articles are

proposed at this time.

Copies of the full text of the proposed

amendments to the Administrative

Manual—Rules of Practice and

Procedure may be obtained by

contacting Susan M. Weisman at the

address provided in FOR FURTHER

INFORMATION CONTACT. Persons wishing

to testify are requested to notify the

Secretary in advance.

Dated: August 18, 1997.

Delaware River Basin Compact, 75 Stat.

688.

Susan M. Weisman,

Secretary.

[FR Doc. 97–23058 Filed 8–28–97; 8:45 am]

BILLING CODE 6360–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 336, 338, 341, and 348

[Docket No. 97N–0128]

RIN 0910–AA01

Labeling of DiphenhydramineContaining Drug Products for Overthe-Counter Human Use

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the tentative final monograph for

over-the-counter (OTC) external

analgesic drug products, and the final

monographs for oral OTC

diphenhydramine drug products for

antiemetic, antihistamine, antitussive,

and nighttime sleep-aid indications. The

amendment adds warning statements

concerning diphenhydramine toxicity.

The proposed warnings advise

consumers not to use topical products

containing diphenhydramine on

chicken pox, poison ivy, sunburn, large

areas of the body, blistered or oozing

skin, more often than directed, or with

any other product containing

diphenhydramine, even one taken by

mouth, and not to use oral OTC

diphenhydramine products with any

other product containing

diphenhydramine including products

used topically. This proposal is part of

the ongoing review of OTC drug

products conducted by FDA.

DATES: Submit written comments by

November 28, 1997. FDA is proposing

that any final rule that may issue based

on this proposal become effective 12

months after the date of its publication

in the Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Nahid Mokhtari-Rejali, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

Diphenhydramine hydrochloride is

proposed for inclusion in the

monograph for OTC external analgesic

drug products for topical use as an

antihistamine external analgesic.
45768 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Proposed Rules

Diphenhydramine hydrochloride is also

included in the OTC drug monograph

for oral use as an antiemetic (21 CFR

part 336). Both diphenhydramine citrate

and diphenhydramine hydrochloride

are included in OTC drug monographs

for oral use as a nighttime sleep-aid (21

CFR part 338), an antihistamine, or an

antitussive (21 CFR part 341). The

various OTC advisory review panels

that reviewed diphenhydramine for

these different uses as part of the OTC

drug review did not consider

interactions that may occur when a

person takes oral diphenhydramine and

applies diphenhydramine topically.

In the Federal Register of December 4,

1979 (44 FR 69768), the Advisory

Review Panel on OTC Topical

Analgesic, Antirheumatic, Otic, Burn,

and Sunburn Prevention and Treatment

Drug products (the Panel) evaluated the

safety and effectiveness of

diphenhydramine hydrochloride as an

antihistamine external analgesic. The

Panel acknowledged that

diphenhydramine is absorbed through

damaged skin and gains access to the

blood stream. However, the Panel did

not consider systemic toxicity from

topical application to be of major

importance because of its low degree of

toxicity when used orally or

parenterally. The Panel was unaware of

any instance of systemic toxicity

reported from topical use of

diphenhydramine. The Panel concluded

that the drug was safe at 1- to 2-percent

concentrations for the temporary relief

of pain and itching due to minor burns,

sunburn, minor cuts, abrasions, insect

bites, and minor skin irritations. The

only warning the Panel recommended

was not to use for longer than 7 days

except under the advice and supervision

of a physician (44 FR 69768 at 69809).

The agency concurred with the

Panel’s recommendations in the

tentative final monograph for OTC

external analgesic drug products,

published in the Federal Register of

February 8, 1983 (48 FR 5852). The

agency did not change the Panel’s

recommended warnings for

diphenhydramine, or add any other

warnings.

II. Developments After Publication of

the External Analgesic Tentative Final

Monograph

Since publication of the external

analgesic tentative final monograph, the

agency has become aware of reports of

adverse events (toxic psychosis),

especially in children, when

diphenhydramine was used topically for

relief of pruritus due to chicken pox,

poison ivy, and sunburn. Some reports

mentioned the concurrent use of topical

diphenhydramine with oral

diphenhydramine drug products to

relieve the itch and rash associated with

chicken pox. Chicken pox is not a

monograph indication for topical or oral

diphenhydramine products.

A. Early Case Reports to FDA

The agency has reviewed case reports

of toxic psychosis reported to its

Spontaneous Reporting System for the

period from 1979 to 1989 (Ref. 1).

In 1979, a 6-year-old boy developed

chicken pox and was treated with

baking soda baths (8 ounce (oz)/tub)

every 2 hours followed by topical

application of a lotion containing 1

percent diphenhydramine and calamine

every 2 hours. Twelve hours later he

developed unusual behavior (talking to

imaginary people, playing with

imaginary toys, did not recognize

parents). On the third day, a doctor saw

the child and prescribed

diphenhydramine elixir every 4 hours.

After 2 doses, the boy became agitated

and his strange ideas became worse. He

was hospitalized with hallucinations,

bizarre inappropriate behavior, and

disorientation to time and place. He was

afebrile. His pupils were dilated and his

face was flushed. Diphenhydramine in

calamine and diphenhydramine elixir

were suspected of causing the toxic

psychosis. The child was given no

medication and the following morning

he was fully alert and his behavior was

normal, without hallucinations or

delusions.

In 1980, a physician reported that

diphenhydramine from a 1 percent

diphenhydramine-calamine lotion was

absorbed in high concentrations in two

patients who were afebrile in the late

stages of chicken pox. The first patient

had diphenhydramine lotion painted on

the body and sealed with a dryer by his

mother. The patient developed

hallucinations and delirium. A second

patient who had the same lotion applied

but not sealed also developed

hallucinations. The physician noted that

hallucinations and delirium would not

be expected in the late stages of this

disease.

In 1987, an 8-year-old child was

admitted to the hospital for severe

psychosis, urinary retention, ataxia,

bizarre posturing, and dilated pupils.

During the 12 hours before admission, 1

percent diphenhydramine-calamine

lotion was applied three different times

on the child from head to toe for severe

poison ivy contact dermatitis. A toxic

drug screen was negative for

diphenhydramine but revealed traces of

benzodiazepine which the child might

have ingested. No other medication was

given. The diphenhydramine lotion was

removed and the child recovered fully.

In 1989, a pharmacist reported that

his 6-year-old son experienced toxic

psychoses (hyperactive, jittery,

disoriented with visual hallucinations)

within 24 hours of application of 1

percent diphenhydramine-calamine

lotion to chicken pox lesions.

Diphenhydramine elixir was given 2

days before and on the day of the topical

application. The child was hospitalized,

treated with activated charcoal, and

recovered completely within 24 hours,

with no further problems.

B. Early Pediatric Literature

Patranella (Ref. 2) reported an

incident where a 4-year-old boy became

toxic after topical application of 3 oz of

1 percent diphenhydramine-calamine

lotion to chicken pox rash. The child

was admitted to the hospital because of

increasing hyperactivity, irregular eye

movements, hallucinations, and

intermittently failing to recognize his

parents. The rash developed the day

before admission, 16 days after exposure

to varicella. The child’s pupils were 4

millimeters in diameter and reacted

sluggishly to light. He was awake,

disoriented to person and place,

combative, ataxic, and displayed tongue

rolling. A urine drug screen revealed the

presence of diphenhydramine. The

lotion was washed from his skin with

water and his mental status returned to

normal within 6 to 8 hours. The report

noted that diphenhydramine is a

histamine (H1) receptor blocker which

can cause central nervous system

excitation or sedation. The fatal dose in

adults is 20 to 40 milligrams/kilogram

(mg/kg). The 4-year-old boy received 50

mg/kg topically over a 6-hour period.

Filloux (Ref. 3) described a 9-year-old

boy with chicken pox who had 1

percent diphenhydramine-calamine

lotion applied liberally from head to toe,

a total of 12 oz in 48 hours, for intense

pruritus. Diphenhydramine toxicity

resulted with organic psychosis

masquerading as varicella encephalitis,

a serious neurologic complication of

varicella zoster (chicken pox) disease

that can result in permanent neurologic

sequelae or death. On admission to the

emergency room, the boy was markedly

agitated, frightened, disoriented,

completely confused, having frequent

visual and auditory hallucinations, and

would assume bizarre postures. Pupils

were dilated but reactive. Laboratory

results were within normal limits. The

serum toxic screen showed a

diphenhydramine level of 1.4

micrograms per milliliter (μg/mL),

which exceeded the therapeutic level of

0.3 μg/mL. No further diphenhydramine
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Proposed Rules 45769

lotion was applied. Although agitated

and hallucinating through the night, the

following morning he was calmer, but

still confused. His diphenhydramine

level had dropped to 0.7 μg/mL. He was

lucid by noon and by 4 p.m. his

diphenhydramine level was 0.6 μg/mL.

He was discharged from the hospital

with a normal mental status. Ample

evidence in this patient confirmed that

transdermal absorption of

diphenhydramine resulted in

intoxication and organic psychosis. The

report advised that appropriate caution

was warranted when treating pruritus

with topical antihistamine preparations,

particularly when substantial epidermal

breakdown exists.

Tomlinson, Helfaer, and Wiedermann

(Ref. 4) described a case of

diphenhydramine toxicity mimicking

varicella encephalitis. Physical

examination disclosed evidence of

diphenhydramine toxicity related to

systemic absorption of a topical

preparation. The patient, a 5-year-old

girl, developed chicken pox rash 4 days

before admission to the hospital. Her

mother had applied 1 percent

diphenhydramine-calamine lotion

repeatedly over most of the child’s body

during this 4-day-period, but gave no

other medications. The day before

admission the child appeared agitated,

did not sleep, had an unsteady gait, and

had trembling of the extremities. Later,

she developed visual hallucinations and

her speech became unintelligible. Upon

admission to the hospital, she was

disoriented, agitated, and grasping at

imaginary objects in the air. Neurologic

examination revealed dilated pupils,

flushed face, and ataxia. A urine toxicity

screen was positive only for

diphenhydramine. The child’s status

improved quickly after the

diphenhydramine lotion was removed.

No other therapy was given and she was

discharged on the fourth day. A

followup examination done 2 weeks

later was normal.

Although initially believed to have

varicella encephalitis, the child’s

symptoms (ataxia, hallucinations,

mydriasis, and flushing of the face) were

more suggestive of an anticholinergic

reaction. Tests confirmed

diphenhydramine toxicity rather than

varicella encephalitis. The report

concurred with one manufacturer’s

recommendations that

diphenhydramine not be used in skin

disorders, such as varicella, where

extensive systemic absorption of topical

preparations may occur. The report

suggested that families of children with

chicken pox be warned to be cautious in

the use of this drug product.

Schunk and Svendsen (Ref. 5)

reported on three children (ages 4, 5,

and 7) with chicken pox who developed

toxic encephalopathy from having been

treated with both oral and topical

diphenhydramine. All displayed some

of the symptoms common to

diphenhydramine toxicity: Dilated

pupils, flushed face, agitation,

confusion, hallucinations, and ataxic

gait. The plasma diphenhydramine level

was 1.5 μg/mL in the 4-year-old and

0.96 μg/mL in the 5-year-old. After

discontinuing the diphenhydramine, all

children displayed normal mental

status.

This report advised that physicians

should be alerted to the possibility of

diphenhydramine toxicity when

confronted with a child with varicella

and acute mental status changes.

Further, both families and physicians

should be advised against combined use

of topical and oral diphenhydraminecontaining preparations.

Woodward and Baldassano (Ref. 6)

described a case of diphenhydramine

intoxication from the combined effects

of oral diphenhydramine elixir and

topical diphenhydramine-calamine

lotion in a 5-year-old boy who

developed chicken pox 3 days before

being taken to the emergency room. He

had been treated with 6 or 7 teaspoons

of oral diphenhydramine (12.5 mg/5

mL) for a total dosage of 75 to 87 mg

(over 36 hours). His mother also had

applied 1 percent diphenhydraminecalamine lotion liberally over his body

in a 12-hour period, 24 hours prior to

presentation in the emergency

department. The boy’s behavior was

bizarre; he was talking to and seeing

objects and people that were not

present. The boy had the classic

symptoms of diphenhydramine toxicity,

including hallucinations, tachycardia,

and dilated pupils. A toxic screen

showed both acetaminophen and

diphenhydramine (1.94/μg/L

approximately 14 hours after the last

oral dose). All diphenhydramine was

discontinued, and the child returned to

normal the next day. Varicella

encephalitis was ruled out. The report

stated that children more often show

excitation with overdosage of

antihistamines than the usual sedative

effect seen in adults.

The article further stated that data on

percutaneous absorption of

diphenhydramine are limited. The

recommended oral dose is 5 mg/kg/24

hours and three to four applications of

topical diphenhydramine lotion per

day. The child had a total of 3.6 mg/kg/

36 hours, or less, of oral

diphenhydramine, less than half the

daily recommended dosage, and a larger

amount of lotion over a 12-hour period.

Therefore, absorption of the lotion

appears to have been a primary factor in

the adverse reaction. The report noted

that toxicity from oral use is more

common than toxicity from topical use

of diphenhydramine. Fatalities have

been reported in both children and

adults from oral overdosage. However,

no deaths have been reported from

topical diphenhydramine use alone. The

report advised that physicians and

patients need to be aware of this

potential toxicity.

C. More Recent Case Reports

Between 1987 and 1990, a major

manufacturer of OTC diphenhydramine

drug products received four adverse

event reports that described toxic

psychoses in seven children (Ref. 7).

Apparently the drug products were

being misused, contrary to labeling, and

were being applied to large areas of the

body where there was broken skin,

possibly causing increased systemic

absorption. Based on these seven cases,

the manufacturer voluntarily revised the

label warnings for its topical products

containing diphenhydramine. In 1989,

the manufacturer added to the following

products a warning not to use on

chicken pox and measles unless

supervised by a doctor: A cream and

lotion product containing 1 percent

diphenhydramine and 8 percent

calamine, and a cream and spray

product containing 1 percent

diphenhydramine and 0.1 percent zinc

acetate. In 1990, the manufacturer

added to these products a second

warning not to use any other drugs

containing diphenhydramine while

using the topical products. This warning

was added based on reports that the

topical diphenhydramine drug products

were being used with oral

diphenhydramine drug products to

relieve the itch and rash associated with

chicken pox and measles, possibly

resulting in toxic serum

diphenhydramine levels. In April 1993,

the manufacturer reformulated its lotion

and cream products containing 1

percent diphenhydramine and 8 percent

calamine to replace the

diphenhydramine with 1 percent

pramoxine hydrochloride.

Summaries of the adverse event

reports received by the manufacturer

follow:

The first report involved a 7-year-old

boy who developed chicken pox. Oral

hydroxyzine hydrochloride (one dose at

6:30 p.m.) was prescribed. The child’s

mother applied 5 to 10 mL of 1 percent

diphenhydramine-calamine lotion three

times to the child’s abdomen and chest

between 7:45 and 11:30 p.m. Around 12
45770 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Proposed Rules

a.m., the child became confused,

irritable, and began hallucinating. When

hospitalized, his diphenhydramine level

at 5:40 a.m. was 73 nanograms per mL

(ng/mL) (the normal level is 25 to 40 ng/

mL). The diphenhydramine-calamine

lotion was removed from the skin and

the child recovered uneventfully the

next day.

The second report involved four

children, ages 4 to 6 years, who

developed chicken pox. Typically, the

mothers applied 1 percent

diphenhydramine-calamine lotion over

an extensive area of the body three to

four times daily. In one case, the child

was concurrently receiving

diphenhydramine syrup. In all cases,

within 24 to 48 hours, the children

became irritable, delirious, and began

hallucinating. The children were treated

in an emergency room by washing the

diphenhydramine lotion from their

bodies, and they responded within 24 to

36 hours.

The third report concerned a 9-yearold boy with a mild sunburn without

broken or blistered skin. An hour after

his mother liberally applied one-half of

a 45-gram tube of 1 percent

diphenhydramine-calamine cream to

the boy’s trunk and limbs, he developed

increased tiredness and became

confused and disoriented. He

convulsed, with widespread muscular

twitching and ‘‘rolling of the eyes’’ 11⁄2

to 2 hours after the cream had been

applied. He was taken to the hospital

and a chemical toxicology screen

revealed a diphenhydramine level of 60

ng/mL. The child was treated with

activated charcoal and intravenous

fluids. Approximately 32 hours later,

the diphenhydramine level was 16 ng/

mL; the child recovered uneventfully

and was discharged the following day.

The fourth report described an 8-yearold boy with a history of allergies and

asthma who developed extensive

chicken pox. One percent

diphenhydramine-calamine lotion was

applied all over the body every 4 to 5

hours for approximately 48 hours. The

child complained of blurred vision and

‘‘not being able to see clearly’’ on the

second day after ‘‘breaking out.’’ He

received acetaminophen every 4 to 5

hours for fever. About 2 to 3 a.m., the

child awoke with hallucinations of

flying insects. A dose of acetaminophen

and a teaspoon of diphenhydramine

elixir were given, and additional

diphenhydramine-calamine lotion was

applied. Afterwards, the boy’s body was

twitching, he was restless and unable to

sit still or sleep. On the advice of the

local emergency room’s personnel, the

child was placed in a cool tub of water

to lower his temperature (103 to 104 °F).

Although his temperature was reduced,

the boy continued to hallucinate. After

another application of

diphenhydramine-calamine lotion, the

child was taken to the hospital around

7 a.m., still hallucinating. Neurological

tests and a test for Reye’s syndrome

were negative, and the child was sent

home. Another dose of

diphenhydramine-calamine lotion was

applied at 11 a.m. and after 1 to 2 hours

the child began to bump into a hallway

wall and was unable to sit still. The last

dose of diphenhydramine lotion was

applied mid-afternoon. A few hours

later, the boy fell asleep for 4 hours,

awoke vomiting, and had difficulty

breathing. After these problems

subsided, the child recovered

uneventfully.

In the last 6 years, FDA has received

several additional reports of toxic

psychoses as a result of topical

application of diphenhydramine. One

doctor reported two cases in children

who had symptoms of delirium from

absorption of diphenhydramine from a

1 percent diphenhydramine-calamine

product applied to their bodies (Ref. 8).

One child had a blood level of 0.31 μg/

mL while the other child’s blood level

was drawn much later and was not

indicative of a toxic level. The doctor

expressed concern about the potential

side effects of the diphenhydramine in

this product.

Chan and Wallender (Ref. 9) reported

three cases of diphenhydramine

toxicity. Two of the cases were included

in earlier articles discussed previously.

The third case described a 2-year-old

boy who developed chicken pox lesions

over his body. He was given an

unknown amount of diphenhydramine

elixir every 3 to 4 hours, and a 1 percent

diphenhydramine-calamine in a lotion

and/or spray was applied topically to

most of his body surface. The child

became increasingly irritable and

displayed inappropriate behavior. The

parents contacted the emergency room

and were instructed to bathe the child

to remove the diphenhydramine lotion.

However, the child continued to have

inappropriate behavior and visual

hallucinations, and was brought to the

emergency room 4 hours later. Vital

signs were temperature 37.1 °C

(rectally), heart rate 124 beats per

minute, and respiration 36 breaths per

minute. Chicken pox lesions covered his

body and, although he had brief periods

of inappropriate behavior, he was able

to follow simple commands. The serum

diphenhydramine concentration was 1.5

μg/mL. Based on laboratory reports,

diphenhydramine concentrations

greater than 0.1 μg/mL are potentially

toxic. After 2 hours of observation, the

boy was dismissed. He was alert and

playful without evidence of toxicity

during a follow-up examination later

that morning.

The report noted that the topical

diphenhydramine products used in

treating the patients discussed in the

article had a label warning against use

in chicken pox unless supervised by a

physician. According to the authors,

cases described in the article

demonstrated three important points.

First, absorption of topically applied

diphenhydramine in patients with

chicken pox and possibly other skin

disorders with extensive disruption of

the skin barrier can occur, resulting in

serious systemic toxicity. Second, the

use of topically applied

diphenhydramine products in this

patient population should be

discouraged. Finally, pharmacists

should educate the public as well as

health professionals regarding the

potential toxicity of these easily

accessible diphenhydramine-containing

nonprescription medications.

McGann et al. (Ref. 10) reported a case

of a 19-month-old girl who developed

chicken pox 5 days before being brought

to the clinic. The girl had been treated

with acetaminophen for fever, colloidal

oatmeal baths, 1 percent

diphenhydramine-calamine lotion

applied to her entire body three or four

times a day, and syrup given in varying

doses totaling approximately 50 mg of

diphenhydramine. Two hours later, the

child began behaving strangely and

rolling her eyes back into her head.

When brought to the clinic, the child

was awake but did not interact with the

examiner. She was moderately agitated

and frightened; would not respond to

commands; had a wide-eyed stare; had

widely dilated pupils that were

sluggishly reactive to light; occasionally

made grimacing, tongue-chewing, and

lip-smacking motions; staggered when

walking; and retained urine. Her serum

diphenhydramine level was 1,948 ng/

mL. The girl was bathed to remove the

diphenhydramine, then admitted to the

hospital for hydration, cardiac

monitoring, bladder catheterization for

urine retention, and observation. After

48 hours, she had returned to normal

and was discharged from the hospital.

The report cautioned parents to

refrain from using topical

diphenhydramine to avoid a serious

life-threatening drug toxicity, and noted

that the drug label specifically warns

against use for chicken pox and measles,

except under the supervision of a

physician. The agency notes that the

labeling directions proposed in

§ 348.50(d) of the tentative final

monograph for OTC external analgesic
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Proposed Rules 45771

drug products (48 FR 5852 at 5869) state

that a doctor should be consulted for

children under 2 years of age. The

report did not indicate whether a doctor

had prescribed the drug.

III. The Agency’s Tentative Conclusions

and Proposal

The case reports described a number

of adverse events resulting from topical

application of diphenhydramine to large

areas of the body, often where there was

broken skin and, in some cases,

concurrent use of topical and oral

diphenhydramine products. The

diphenhydramine products were used

to relieve pain and itching due to

chicken pox (most cases), poison ivy (1

case), and sunburn (1 case). The age

range of the patients with reactions was

19 months to 9 years. The symptoms

determined to be most suggestive of

diphenhydramine toxicity included

dilated pupils, flushed face,

hallucinations, ataxic gait, and urinary

retention. As the Panel noted (44 FR

69768 at 69809), diphenhydramine is

absorbed through damaged skin, and the

case reports confirmed that transdermal

absorption occurs. In some cases, high

serum concentrations confirmed

diphenhydramine toxicity. Symptoms

gradually disappeared when

diphenhydramine was removed from

the body by bathing and oral

administration of diphenhydramine was

discontinued. Most patients returned to

normal in about 48 hours after the drug

was withdrawn. No deaths have been

reported from topical diphenhydramine

use alone.

The authors of many of these reports

have indicated the need to inform

health professionals and consumers

about the situations when topical

diphenhydramine should not be used,

especially in conjunction with oral

diphenhydramine. This is especially

true in patients with chicken pox and

possibly other skin disorders with

extensive disruption of the skin barrier,

which can result in serious systemic

toxicity if absorption of

diphenhydramine occurs. As noted in

section II.C. of this document, a major

manufacturer of OTC diphenhydramine

drug products voluntarily added

warning information to the labeling of

its topical products.

The agency believes there is

underreporting of adverse reactions for

topical diphenhydramine drug

products. There is currently no adverse

event reporting requirement for topical

diphenhydramine products included in

an OTC drug monograph. In addition,

the agency is concerned that consumers,

primarily parents, may use these topical

products casually because they consider

them to be innocuous. Because the exact

extent of the problem is not known, and

there is a potentially large exposure of

the general population to this

ingredient, the agency has determined

that additional warnings are needed to

avoid the possibility of serious adverse

reactions. A sufficient number of

significant serious neuropsychiatric

events have already occurred (especially

in children) to propose a change in the

labeled warnings for both topical and

oral diphenhydramine products. In this

document, the agency is proposing to

require the following additional

warning for topical products containing

diphenhydramine: ‘‘Do Not Use’’ (these

three words in bold print) ‘‘on chicken

pox, poison ivy, sunburn, large areas of

the body, broken, blistered, or oozing

skin, more often than directed, or with

any other product containing

diphenhydramine, even one taken by

mouth.’’

The agency notes that one

manufacturer includes ‘‘not to use on

measles’’ in the warning that it

voluntarily added to its topical

diphenhydramine products. However,

because none of the case reports were

associated with measles lesions, the

agency has not specifically listed

measles in the warning. The agency

invites interested persons to submit any

available information related to any

adverse events associated with the

topical application of diphenhydramine

to measles.

Manufacturers may use bullet points

or other identifying marks to emphasize

the subparts of this warning. The format

of this warning might look something

like the following:

Do Not Use (these words in bold

print):

• on chicken pox, poison ivy, sunburn

• on large areas of the body

• on broken, blistered, or oozing skin

• more often than directed

• with any other product containing

diphenhydramine, even one taken by

mouth

The agency is proposing this warning

in new § 348.50(c)(10) under the

heading For products containing

diphenhydramine hydrochloride

identified in § 348.10(c)(1). For these

products, this warning shall be the first

statement under the heading

‘‘Warnings:’’

In addition, in §§ 336.50, 338.50,

341.72, and 341.74 the agency is

proposing an additional warning for oral

drug products that contain

diphenhydramine. The warning states:

‘‘Do Not Use’’ (these three words in bold

print) ‘‘with any other product

containing diphenhydramine, including

one applied topically.’’ The agency

believes that this warning statement will

help reduce the toxicity that may occur

from the inadvertent concurrent use of

several products containing

diphenhydramine. The agency points

out that its recent final rule/enforcement

policy that provides for

diphenhydramine citrate or

diphenhydramine hydrochloride to be

labeled for concurrent antihistamine

and antitussive use should also help

reduce the toxicity that may occur from

the concurrent administration of more

than one oral product containing

diphenhydramine. (See the Federal

Register of April 9, 1996 (61 FR 15700).)

Manufacturers of OTC topical and

oral diphenhydramine drug products

are encouraged to implement this

labeling addition voluntarily as soon as

possible after publication of this

proposal, subject to the possibility that

FDA may change the wording of the

warning statement as a result of

comments filed in response to this

proposal. Because FDA is encouraging

the voluntary use of the proposed

additional warning statement at this

time, the agency advises that

manufacturers will be given ample time

after publication of a final rule to use up

any labeling voluntarily implemented in

conformance with this proposal.

IV. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

(1) Drug Experience Reports No. 801101–

034–00101, 80051000100501,

8706110020071, 89081500100012,

89081500100011, OTC Vol. 06DTFM, Docket

No. 78N–0301, Dockets Management Branch.

(2) Patranella, P., ‘‘Diphenhydramine

Toxicity Due to Topical Application of

Caladryl,’’ Clinical Pediatrics, 3:163, 1986.

(3) Filloux, F., ‘‘Toxic Encephalopathy

Caused by Topically Applied

Diphenhydramine,’’ The Journal of

Pediatrics, 108:1018–1020, 1986.

(4) Tomlinson, G., M. Helfaer, and B.

Wiedermann, ‘‘Diphenhydramine Toxicity

Mimicking Varicella Encephalitis,’’ The

Pediatric Infectious Disease Journal, 6:220–

221, 1987.

(5) Schunk, J. E., and D. Svendsen,

‘‘Diphenhydramine Toxicity from Combined

Oral and Topical Use,’’ The Pediatric Forum,

142:1020–1021, 1988.

(6) Woodward, G. A., and R. N. Baldassano,

‘‘Topical Diphenhydramine Toxicity in a

Five-Year Old with Varicella,’’ Pediatric

Emergency Care, 4:18–20, 1988.

(7) Letter dated December 14, 1993, from

R. G. Kohler, Warner Lambert Co. to W. E.

Gilbertson, FDA, in OTC Vol. 06DTFM,

Docket No. 78N–0301, Dockets Management

Branch.
45772 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Proposed Rules

(8) Drug Experience Report No. 698132,

OTC Vol. 06DTFM, Docket No. 78N–0301,

Dockets Management Branch.

(9) Chan, C. Y. J., and K. A. Wallander,

‘‘Diphenhydramine Toxicity in Three

Children with Varicella-Zoster Infection,’’

The Annals of Pharmacology, 25:130–132,

1991.

(10) McGann, K. P. et al.,

‘‘Diphenhydramine Toxicity in a Child with

Varicella,’’ A Case Report, The Journal of

Family Practice, 35:210–214, 1992.

V. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612). Executive Order

12866 directs agencies to assess all costs

and benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). Under the

Regulatory Flexibility Act, if a rule has

a significant economic impact on a

substantial number of small entities, an

agency must analyze regulatory options

that would minimize any significant

economic impact of a rule on small

entities.

Title II of the Unfunded Mandates

Reform Act (21 U.S.C. 1501 et seq.)

requires that agencies prepare a written

statement and economic analysis before

proposing any rule that may result in an

expenditure in any 1 year by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million (adjusted annually for

inflation).

The agency believes that this

proposed rule is consistent with the

principles set out in the Executive Order

and in these two statutes. The purpose

of this proposed rule is to add warning

statements to the labeling of oral and

topical OTC drug products that contain

diphenhydramine. These warning

statements concern diphenhydramine

toxicity and are intended to help ensure

the safe and effective use of all OTC

drug products that contain this

ingredient. Potential benefits include

reduced toxicity when consumers use

these products.

This proposed rule amends the final

monographs for oral OTC

diphenhydramine drug products for

antiemetic, antihistamine, antitussive,

and nighttime sleep-aid indications and

will require some relabeling of these

products to add the new warning

statement. The proposed rule also

amends the tentative final monograph

for OTC external analgesic drug

products and will require some

relabeling to add the new warning

statement to products containing

diphenhydramine. The agency’s drug

listing system identifies approximately

100 manufacturers and 300 marketers of

over 800 oral OTC diphenhydramine

drug products, and 10 manufacturers

and 50 marketers of over 100 topical

OTC diphenhydramine drug products. It

is likely that there are some additional

marketers and products that are not

currently included in the agency’s

system. However, after adjusting for

overlap among the oral and external

counts, the agency estimates that there

are a total of 100 manufacturers and 300

marketers of about 1,000 affected stock

keeping units (SKU) (individual

products, packages, and sizes).

The agency has been informed that

relabeling costs of this type generally

average about $2,000 to $3,000 per SKU.

Assuming that there are about 1,000

affected OTC SKU’s in the marketplace,

total one-time costs of relabeling would

be $2 to $3 million. The agency believes

that actual costs would be lower for

several reasons. First, most of the label

changes will be made by private label

manufacturers that tend to use relatively

simple and less expensive labeling.

Second, for oral OTC diphenhydramine

drug products, the agency is proposing

a 12-month implementation period that

would allow many manufacturers to

coordinate this change with routinely

scheduled label printing and/or

revisions. Similarly, labeling changes

for external OTC diphenhydramine drug

products would not be required until

that monograph is issued and becomes

final. Thus, the relabeling costs for a

warning statement on these products

would be mitigated or eliminated. In

addition, because the new warning

statement involves only a single

sentence, supplementary labeling (e.g.,

stick on labeling) could be used for

those oral products not undergoing a

new labeling printing within this 1-year

period.

The proposed rule would not require

any new reporting and recordkeeping

activities. Therefore, no additional

professional skills are needed. There are

no other Federal rules that duplicate,

overlap, or conflict with the proposed

rule. The agency does not believe that

there are any significant alternatives to

the proposed rule that would adequately

provide for the safe and effective OTC

use of drug products that contain

diphenhydramine.

This proposed rule may have a

significant economic impact on some

small entities. The labeling of many of

the affected products is prepared by

private label manufacturers for small

marketers. Census data provide

aggregate industry statistics on the total

number of manufacturers for

Standardized Industrial Classification

Code 2834 Pharmaceutical Preparations

by establishment size, but do not

distinguish between manufacturers of

prescription and OTC drug products.

According to the U.S. Small Business

Administration (SBA) designations for

this industry, over 92 percent of the

roughly 700 establishments and over 87

percent of the 650 firms are small.

(Because census size categories do not

correspond to the SBA designation of

750 employees, these figures are based

on 500 employees.)

An analysis of IMS Co. listings for

manufacturers of OTC drug products

found that from 46 to 69 percent of the

400 listed firms are small using the SBA

definition of 750 employees. The

agency’s drug listing system indicates

that about 300 marketers will need to

relabel, and that this relabeling will be

prepared by about 100 entities, most of

which are private label manufacturers.

Thus, the agency believes that most of

the manufacturers affected by this

proposed rule would be small.

Because this regulation would affect

the information content of all OTC drug

products that contain diphenhydramine,

firms that manufacture or relabel these

OTC drug products will need to change

the information panel for each affected

SKU. Some of these costs of doing so

will be mitigated because the agency is

allowing up to 1 year for oral products

so that the required labeling revision

may be made in the normal course of

business. Labeling changes for topical

products may be coordinated with the

final monograph for OTC external

analgesic drug products. Among the

steps the agency is taking to minimize

the impact on small entities are: (1) To

provide enough time for

implementation to enable entities to use

up existing labeling stock, and (2) to

provide for the use of supplementary

labeling (e.g., stick on labeling) if

necessary. The agency believes that

these actions provide substantial

flexibility and reductions in cost for

small entities.

The agency considered but rejected

several labeling alternatives: (1)

Voluntary relabeling, (2) a longer

implementation period, and (3) an

exemption from coverage for small

entities. The agency does not consider

any of these approaches acceptable

because they do not assure that

consumers will have the most recent

needed information for safe and

effective use of OTC diphenhydramine

drug products at the earliest possible

time.
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Proposed Rules 45773

This analysis shows that this

proposed rule is not economically

significant under Executive Order 12866

and that the agency has undertaken

important steps to reduce the burden to

small entities. Nevertheless, some

entities, especially those private label

manufacturers that provide labeling for

a number of the affected products, may

incur significant impacts. Thus, this

economic analysis, together with other

relevant sections of this document,

serves as the agency’s initial regulatory

flexibility analysis, as required under

the Regulatory Flexibility Act. Finally,

this analysis shows that the Unfunded

Mandates Act does not apply to the

proposed rule because it would not

result in an expenditure in any 1 year

by State, local, and tribal governments,

in the aggregate, or by the private sector,

of $100 million.

The agency invites public comment

regarding any economic impact that this

rulemaking would have on

manufacturers of OTC oral and topical

drug products containing

diphenhydramine hydrochloride.

Comments regarding the economic

impact of this rulemaking on such

manufacturers should be accompanied

by appropriate documentation. The

agency is providing a period of 90 days

from the date of publication of this

proposed rulemaking in the Federal

Register for comments on this subject to

be developed and submitted. The

agency will evaluate any comments and

supporting data that are received and

will reassess the economic impact of

this rulemaking in the preamble to the

final rule.

VI. Paperwork Reduction Act of 1995

FDA tentatively concludes that the

labeling requirements proposed in this

document for oral and topical OTC drug

products are not subject to review by the

Office of Management and Budget

because they do not constitute a

‘‘collection of information’’ under the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.). Rather, the

proposed warning statements are a

‘‘public disclosure of information

originally supplied by the Federal

government to the recipient for the

purpose of disclosure to the public’’ (5

CFR 1320.3(c)(2)).

VII. Environmental Impact

The agency has determined under 21

CFR 25.24(c)(6) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VIII. Request for Comments

Interested persons may, on or before

November 28, 1997, submit written

comments on the proposed regulations

to the Dockets Management Branch

(address above). Written comments on

the agency’s economic impact

determination may be submitted on or

before November 28, 1997. Three copies

of all comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document and may be accompanied by

a supporting memorandum or brief.

Received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects in 21 CFR Parts 336,

338, 341, 348

Labeling, Over-the-counter drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR parts 336, 338, and 341, and 21

CFR part 348 (as proposed in the

Federal Register of February 8, 1983 (48

FR 5852)) be amended as follows:

PART 336—ANTIEMETIC DRUG

PRODUCTS FOR OVER–THE–

COUNTER HUMAN USE

1. The authority citation for 21 CFR

part 336 continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505,

510, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371).

2. Section 336.50 is amended by

adding new paragraph (c)(8) to read as

follows:

§ 336.50 Labeling of antiemetic drug

products.

* * * * *

(c) * * *

(8) For products containing

diphenhydramine hydrochloride

identified in § 336.10(c). ‘‘Do Not Use’’

(these three words in bold print) ‘‘with

any other product containing

diphenhydramine, including one

applied topically.’’

* * * * *

PART 338—NIGHTTIME SLEEP–AID

DRUG PRODUCTS FOR OVER–THE–

COUNTER HUMAN USE

3. The authority citation for 21 CFR

part 338 continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505,

510, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371).

4. Section 338.50 is amended by

adding new paragraph (c)(5) to read as

follows:

§ 338.50 Labeling of nighttime sleep-aid

drug products.

* * * * *

(c) * * *

(5) ‘‘Do Not Use’’ (these three words

in bold print) ‘‘with any other product

containing diphenhydramine, including

one applied topically.’’

* * * * *

PART 341—COLD, COUGH, ALLERGY,

BRONCHODILATOR, AND

ANTIASTHMATIC DRUG PRODUCTS

FOR OVER–THE–COUNTER HUMAN

USE

5. The authority citation for 21 CFR

part 341 continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505,

510, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371).

6. Section 341.72 is amended by

adding new paragraphs (c)(6)(iv) and

(c)(7) to read as follows:

§ 341.72 Labeling of antihistamine drug

products.

* * * * *

(c) * * *

(6) * * *

(iv) For products containing

diphenhydramine citrate or

diphenhydramine hydrochloride

identified in § 341.12(f) and (g). ‘‘Do Not

Use’’ (these three words in bold print)

‘‘with any other product containing

diphenhydramine, including one

applied topically.’’

(7) For products containing

diphenhydramine citrate or

diphenhydramine hydrochloride

identified in § 341.12(f) and (g). ‘‘Do Not

Use:’’ (these three words in bold print)

‘‘with any other product containing

diphenhydramine, including one

applied topically.’’

* * * * *

7. Section 341.74 is amended by

adding new paragraphs (c)(4)(viii)(C)

and (c)(4)(ix)(C) to read as follows:

§ 341.74 Labeling of antitussive drug

products.

* * * * *

(c) * * *

(4) * * *

(viii) * * *

(C) ‘‘Do Not Use’’ (these three words

in bold print) ‘‘with any other product

containing diphenhydramine, including

one applied topically.’’

(ix) * * *

(C) ‘‘Do Not Use’’ (these three words

in bold print) ‘‘with any other product
45774 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Proposed Rules

containing diphenhydramine, including

one applied topically.’’

* * * * *

PART 348—EXTERNAL ANALGESIC

DRUG PRODUCTS FOR OVER–THE–

COUNTER HUMAN USE

8. The authority citation for 21 CFR

part 348 continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505,

510, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371).

9. Section 348.50 (as proposed at 48

FR 5852, February 8, 1983) is amended

by adding new paragraph (c)(10) to read

as follows:

§ 348.50 Labeling of external analgesic

drug products.

* * * * *

(c) * * *

(10) For products containing

diphenhydramine hydrochloride

identified in § 348.10(c)(1). The

following statement shall appear as the

first warning statement under the

heading ‘‘Warnings:’’ ‘‘Do Not Use:’’

(these three words in bold print) ‘‘on

chicken pox, poison ivy, sunburn, large

areas of the body, broken, blistered, or

oozing skin, more often than directed, or

with any other product containing

diphenhydramine, even one taken by

mouth.’’

* * * * *

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22983 Filed 8–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Civil Division; Radiation Exposure

Compensation Act: Evidentiary

Requirements; Definitions and Number

of Claims Filed

28 CFR Part 79

[A.G. Order No. 2111–97]

RIN 1105–AA49

AGENCY: Civil Division, Department of

Justice.

ACTION: Notice of reopening of comment

period for proposed rule.

SUMMARY: On May 23, 1997, the United

States Department of Justice (DOJ)

published a proposed rule amending the

existing regulations implementing the

Radiation Exposure Compensation Act.

This proposed rule may be found at 62

FR 28393, May 23, 1997. The original 60

day comment period expired on July 22,

1997.

Several individuals have requested

additional time to submit comments

regarding the proposed changes. To

ensure that the public has ample

opportunity to fully review and

comment on the proposed amendments,

we are now extending the comment

period and will accept comments for an

additional 30 days after publication of

this notice.

DATES: Written comments must be

submitted on or before September 29,

1997.

ADDRESSES: Please submit written

comments to Gerard W. Fischer,

Assistant Director, U.S. Department of

Justice, Civil Division, P.O. Box 146,

Ben Franklin Station, Washington, D.C.

20044–0146.

FOR FURTHER INFORMATION CONTACT:

Gerard W. Fischer (Assistant Director),

(202) 616–4090 and Lori Beg (Attorney),

(202) 616–4377.

Dated: August 25, 1997.

Janet Reno,

Attorney General.

[FR Doc. 97–23015 Filed 8–28–97; 8:45 am]

BILLING CODE 4410–12–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Parts 148–150

[CGD 97–050]

Deepwater Ports

AGENCY: Coast Guard, DOT.

ACTION: Advanced notice of proposed

rulemaking; request for comments.

SUMMARY: The Coast Guard, in an effort

to continually update its regulations and

in response to recent legislation, plans

to revise the Deepwater Port regulations.

The Coast Guard solicits comments from

the public and industry on the questions

listed in this request.

DATES: Comments must reach the Coast

Guard on or before October 14, 1997.

ADDRESSES: You may mail comments to

the Executive Secretary, Marine Safety

Council (G–LRA) (CGD 97–050), U.S.

Coast Guard, 2100 Second Street SW.,

Washington, DC 20593–0001, or deliver

them to room 3406 at the same address

between 9:30 a.m. and 2 p.m., Monday

through Friday, except Federal holidays.

The telephone number is (202) 267–

1477.

The Executive Secretary maintains the

public docket for this rulemaking.

Comments and documents as indicated

in this preamble, will become part of

this docket and will be available for

inspection or copying at room 3406,

U.S. Coast Guard Headquarters, between

9:30 a.m. and 2 p.m., Monday through

Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

LT Diane Foster, Office of Operating and

Environmental Standards (G–MSO–2),

Room 1210, U.S. Coast Guard

Headquarters, 2100 Second Street SW.,

Washington, DC 20593, telephone (202)

267–1181.

SUPPLEMENTARY INFORMATION:

Request for Information

The Coast Guard encourages

interested persons to participate in this

request by submitting written data,

views, or arguments. Persons submitting

comments should include their names

and addresses, identify this notice (CGD

97–050) and the specific section or

question of this document to which

each comment or question applies, and

give the reason for each comment.

Please submit two copies of all

comments and attachments in an

unbound format, no larger than 81⁄2 by

11 inches, suitable for copying and

electronic filing. Persons wanting

acknowledgement of receipt of

comments should enclose stamped, selfaddressed postcards or envelopes. The

Coast Guard will consider all comments

received during the comment period.

The Coast Guard plans no public

meeting. Persons may request a public

meeting by writing to the Marine Safety

Council at the address under

ADDRESSES. The request should include

the reasons why a meeting would be

beneficial. If it is determined that the

opportunity for oral presentations will

aid this rulemaking, the Coast Guard

will hold a public meeting at a time and

place announced by a later notice in the

Federal Register.

Background and Purpose

The Coast Guard Authorization Act of

1996 prescribes changes to the

regulations developed in accordance

with the Deepwater Port Act of 1974,

and contained in 33 CFR Parts 148 to

150. The changes include:

1. Removing from the regulations and

placing in the license conditions, those

requirements necessary to carry out the

provisions of the Deepwater Port Act;

2. Removing from the regulations and

license conditions, those things which

can be stated in an approved operations

manual. Basic standards and conditions,

however, will continue to be addressed

in the regulations.

The Deepwater Port regulations were

written in the 1970’s when there were