This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

51071

Vol. 62, No. 189

Tuesday, September 30, 1997

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 312, 314, and 601

[Docket No. 97N–0165]

RIN 0910–AB20

Regulations Requiring Manufacturers

to Assess the Safety and Effectiveness

of New Drugs and Biological Products

in Pediatric Patients; Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notification of a public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting to discuss issues related

to the agency’s proposed rule on

regulations requiring manufacturers to

assess the safety and effectiveness of

new drugs and biological products in

pediatric patients. The proposed rule,

previously announced in the Federal

Register, requested written comments

and proposed new regulations requiring

pediatric studies of certain new drug

and biological products. The purpose of

the meeting is to provide experts in the

field and interested individuals an

opportunity to discuss specific issues

raised by the proposed rule. The agency

is seeking comment and specific data on

the proposed rule.

DATES: The public meeting will be held

on October 27, 1997, from 9 a.m. to 6

p.m. Please arrive no later than 8:30

a.m. to allow time for security clearance.

Written requests for oral presentations

should be received by the agency on or

before October 14, 1997. Written

comments must be submitted on or

before November 13, 1997.

ADDRESSES: The public meeting will be

held at the Cohen Bldg., auditorium,

330 C St. SW., Washington, DC. Submit

written requests for oral presentations to

Lisa Barclay, Office of Policy (HF–22),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857. To

expedite processing, fax written

requests for oral presentations to 301–

594–6777. To ensure timely handling,

the outer envelope or facsimile cover

sheet should be clearly marked with:

Docket No. 97N–0165, ‘‘Pediatric

Labeling Meeting,’’ ATTN: Lisa Barclay.

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:

Khyati N. Roberts, Center for Drug

Evaluation and Research (HFD–6),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–594–6779, FAX 301–

594–5493, e-mail

robertsk@cder.fda.gov, or

Elaine C. Esber, Center for Biologics

Evaluation and Research (HFM–30),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–0641, FAX 301–

827–0644, e-mail

esber@1.cber.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of August 15,

1997 (62 FR 43900), the agency

published a proposed rule for new

regulations requiring pediatric studies

of certain new drug and biological

products. The proposed rule would

attempt to partially address a lack of

pediatric use information by requiring

that manufacturers of a limited class of

new drug and biological products

provide sufficient data and information

to support directions for pediatric use

for the claimed indications before, or

soon after, approval. Manufacturers of a

limited class of already marketed drugs

and biologics would also, in compelling

circumstances, have to provide such

data. The proposed rule is part of a

comprehensive effort to increase the

number of new drug and biological

products with clinically significant use

in children that carry adequate labeling

for use in that subpopulation.

Because of the importance of ensuring

the safety and effectiveness of the

medications administered to children

and the need to address the absence of

pediatric labeling in the most effective

manner possible, FDA, in cooperation

with the American Academy of

Pediatrics, is announcing a public

meeting at which recognized experts in

the field, members of the

pharmaceutical industry, and other

interested parties will have an

opportunity to discuss certain issues

raised by the proposed rule. FDA will

consider information presented and

discussed at the meeting and written

comments submitted to the Dockets

Management Branch in the development

of the final rule. There is no fee for this

public meeting.

II. Scope of Meeting

The purpose of this meeting is to

complement the process for gathering

written comments and

recommendations on certain issues

raised by the proposed rule. The

meeting will provide recognized experts

in the field, members of the

pharmaceutical industry, and other

interested parties an opportunity to

discuss these issues. The agency is

specifically seeking comment and data

on the following:

(1) What should be considered a

‘‘substantial number’’ of pediatric

patients?

(2) Whether the rule should be

restricted to new chemical entities,

including new (never-before-approved)

drugs, antibiotics and biological

products, or whether it should be

applied more broadly (e.g., to

applications for chemical variations of

approved products, new indications,

new dosage forms or routes of

administration)?

(3) Whether the proposed grounds for

waiving the pediatric study requirement

are adequate and whether additional

grounds may exist?

(4) What would constitute sufficient

data or an adequate pediatric clinical

trial? and

(5) How should dose and safety levels

for each of the different pediatric age

groups or stages of development be

established? Relevant to this issue, the

agency solicits comment on special

problems associated with studies in

neonates and young infants.

III. Requests for Oral Presentations

Persons who wish to participate in the

meeting must file a written or facsimile

request for oral presentation with the

Office of Policy (address and fax

numbers above). The request for oral

presentation should contain the

speaker’s name, address, telephone and

fax numbers, title, business affiliation, if

any, topic, a brief summary of the
51072 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Proposed Rules

presentation, and approximate amount

of time requested for the presentation.

The agency requests that persons or

groups having similar interests

consolidate their presentations and

present them through a single

representative. Because presentations

will be limited to 1 day, the agency may

not be able to accommodate all requests

for oral presentations. FDA will allocate

the time available for the meeting

among the persons who properly file

requests for oral presentations. If time

permits at the conclusion of the

meeting, FDA may allow participation

from both interested persons attending

the meeting who did not submit a

written request for an oral presentation

and those who requested an opportunity

to make a presentation, but, due to the

time limitations, were not granted the

request.

IV. Requests for Comments

Interested persons may, on or before

November 13, 1997, submit written

comments to the Dockets Management

Branch (address above). Two copies of

any 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. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

V. Special Accommodations

In order to accommodate the need for

space or technical support, persons who

are planning on using audiovisual

equipment during their oral

presentations are urged to provide

advance notice of their planned

attendance to one of the contact persons

identified above. If you need special

accommodations due to a disability,

please contact one of the contact

persons listed above at least 7 days in

advance.

VI. Transcripts

Transcripts of the meeting may be

requested in writing from the Freedom

of Information Office (HFI–35), Food

and Drug Administration, 5600 Fishers

Lane, rm. 12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

Dated: September 24, 1997,

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25937 Filed 9-29-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA–156P]

RIN #1117–aa43

Listed Chemicals; Proposed

Establishment of Thresholds for Iodine

and Hydrochloric Gas (Hydrogen

Chloride Gas)

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Comprehensive

Methamphetamine Control Act of 1996

(MCA) establishes that, effective

October 3, 1996, iodine and hydrogen

chloride gas are List II chemicals under

the Controlled Substances Act (CSA).

The inclusion of these chemicals under

the CSA requires that each regulated

person must keep records and file

reports as specified in Title 21 Code

Federal Regulations (21 CFR) Part 1310.

Since the MCA did not establish

thresholds for iodine and hydrogen

chloride gas, recordkeeping and

reporting requirements became

applicable to all domestic transactions

of these chemicals. While this notice of

proposed rulemaking is proposing a

domestic threshold of 0.0 kilograms for

hydrogen chloride gas, it proposes to set

a domestic threshold of 0.4 kilograms

for iodine. This iodine threshold will

remove the recordkeeping requirement

for many iodine transactions.

This notice of proposed rulemaking

also proposes to reinsert the table in 21

CFR 1310.04(f)(2)(iv), listing thresholds

for exports, transshipments, and

international transactions to designated

countries set forth in 1310.08(b). The

DEA’s final rule regarding

implementation of the Domestic

Chemical Diversion Control Act of 1993,

published on June 22, 1995 [60 FR

32447] inadvertently omitted the table

from the section.

DATES: Written comments or objections

must be received on or before December

1, 1997.

ADDRESSES: Comments and objections

should be submitted in quintuplicate to

the Deputy Assistant Administrator,

Office of Diversion Control, Drug

Enforcement Administration,

Washington, D.C. 20537, Attention: DEA

Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT:

Frank Sapienza, Chief, Drug and

Chemical Evaluation Section, Office of

Diversion Control, Drug Enforcement

Administration, Washington, D.C.

20537, Telephone (202) 307–7183.

SUPPLEMENTARY INFORMATION: The MCA

was signed into law on October 3, 1996,

Section 204 of the MCA amends Section

102(35) of the CSA (21 U.S.C. 802(35))

to include iodine and hydrogen chloride

gas as List II chemicals. Section 204(b)

(1) and (2) of the MCA also states that

‘‘iodine shall not be subject to the

requirements for listed chemicals

provided in section 1018 of the

Controlled Substances Import and

Export Act (21 U.S.C. 971).’’ Therefore,

the MCA does not impose import/export

requirements on iodine. The MCA,

however, does not ‘‘limit the authority

of the Attorney General to impose the

requirements for listed chemicals

provided in section 1018 of the

Controlled Substances Import and

Export Act (21 U.S.C. 971).’’ Although

the DEA is not imposing import/export

restrictions on iodine at this time, the

DEA is currently reviewing available

data on iodine to determine if such

controls are warranted.

Prior to the MCA, hydrogen chloride

gas, also known as anhydrous

hydrochloric acid, was already a List II

chemical under the CSA (21 CFR

1310.02(b)(8)). Pursuant to 21 CFR

1310.08, all domestic and import

transactions of hydrogen chloride gas

have been exempt from the regulatory

controls under the CSA. In addition, all

exports, transshipments and

international transactions of hydrogen

chloride gas have been exempt from the

regulatory controls except those to all

South American countries and Panama.

Exports to all South American countries

and Panama above a threshold of 27

kilograms have been regulated

transactions (21 CFR 1310.08(b)). The

MCA amends the CSA to impose only

domestic controls on iodine and

domestic and international controls on

hydrogen chloride gas.

The majority of the clandestine

laboratories seized in the United States

manufacture methamphetamine, a

Schedule II controlled substance. Since

1990, more than 2,400

methamphetamine laboratories have

been seized in the United States by the

DEA. The most frequently used

synthesis among clandestine laboratory

operators today is the ephedrine/

pseudoephedrine reduction method

which utilizes hydriodic acid.

Hydriodic acid is a List I chemical with

a domestic threshold of one liter. With

the increased controls on hydriodic

acid, clandestine laboratory operators

have turned to producing their own

hydriodic acid or using iodine directly

in the synthesis. Clandestine laboratory