46198 Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Rules and Regulations

(c) If no response is made within

twenty (20) working days or any

extension thereof, the requester can

consider his or her administrative

remedies exhausted and seek judicial

relief in a United States District Court as

specified in 5 U.S.C. 552(a)(4)(B). * * *

8. Section 1015.9 is amended by

revising paragraphs (e)(5) and (g)(1) to

read as follows:

§ 1015.9 Fees for production of records.

* * * * *

(e) * * *

(5) Computerized records: $0.10 per

page of computer printouts or, for

central processing, $0.32 per second of

central processing unit (CPU) time; for

printer, $10.00 per 1,000 lines; and for

computer magnetic tapes or discs, direct

costs.

* * * * *

(g) * * *

(1) Interest will be charged on

amounts billed, starting on the 31st day

following the day on which the

requester received the bill. Interest will

be at the rate prescribed in 31 U.S.C.

3717.

* * * * *

9. Section 1015.10 is amended by

revising the introductory text and

paragraphs (b) through (g) as follows:

§ 1015.10 Commission report of actions to

Congress.

On or before February 1 of each year,

the Commission shall submit a report of

its activities with regard to freedom of

information requests during the

preceding fiscal year to the Attorney

General of the United States. This report

shall include:

* * * * *

(b)(1) The number of appeals made by

persons under such provisions, the

result of such appeals, and the reason

for the action upon each appeal that

results in a denial of information; and

(2) A complete list of all statutes that

the Commission relies upon to withhold

information under such provisions, a

description of whether a court has

upheld the decision of the Commission

to withhold information under each

such statute, and a concise description

of the scope of any information

withheld.

(c) The number of requests for records

pending before the Commission as of

September 30 of the preceding year, and

the median number of days that such

requests had been pending before the

Commission as of that date.

(d) The number of requests for records

received by the Commission and the

number of requests which the

Commission processed.

(e) The median number of days taken

by the Commission to process different

types of requests.

(f) The total amount of fees collected

by the Commission for processing

requests.

(g) The number of full-time staff of the

Commission devoted to processing

requests for records under such

provisions, and the total amount

expended by the Commission for

processing such requests.

Dated: August 26, 1997.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 97–23242 Filed 8–29–97; 8:45 am]

BILLING CODE 6355–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50, 56, 312, 314, 601, 812,

and 814

[Docket No. 97N–0342]

Implementation of Emergency

Research Informed Consent Waiver

Rule; 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 on the implementation

of a final rule that defined conditions

for an exception to the normal

requirements for obtaining informed

consent from persons participating as

subjects in research. FDA is holding the

public meeting because some parties

interested in research conducted under

the final rule have expressed to FDA a

need for additional information on

acceptable implementation procedures.

The purpose of this public meeting is to

provide an open discussion of the issues

involved in implementing the

requirements of the rule.

DATES: The public meeting will be held

on September 29 and 30, 1997. On

September 29, 1997, the meeting will be

from 9:30 a.m. to approximately 5:30

p.m. On September 30, 1997, the

meeting will be from 8 a.m. to

approximately 11:45 a.m. Registration is

recommended by September 19, 1997.

Opportunity for public participation

will be provided during both days of the

meeting. Written comments will be

accepted until October 31, 1997.

ADDRESSES: The public meeting will be

held at the Bethesda Holiday Inn, 8120

Wisconsin Ave., Bethesda, MD. Written

information and comments related to

the meeting should be sent to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

FOR FURTHER INFORMATION CONTACT: Glen

D. Drew, Office of Health Affairs (HFY–

20), Food and Drug Administration,

5600 Fishers Lane, rm. 15–22, Rockville,

MD 20857, 301–443–1382, FAX 301–

443–0232.

SUPPLEMENTARY INFORMATION: The

purpose of this public meeting is to

provide an open discussion of the issues

involved in implementing the

requirements of the final rule.

Participants will be encouraged to

discuss their perspectives on

implementation of the final rule.

Members of the public are encouraged

to attend and provide comments during

periods of open discussion and to

provide written comments to the docket.

Written comments by interested parties

are encouraged, whether or not they are

able to attend the public meeting.

The requirement for obtaining the

informed consent of persons

participating in clinical research as

research subjects has long been

recognized, and has been included in

FDA’s regulations since the early 1960’s.

The current regulations on informed

consent part 50 (21 CFR part 50) and

institutional review boards (IRB’s) (21

CFR part 56) were finalized in 1981.

Those regulations require that clinical

researchers obtain informed consent

from all subjects, with narrowly limited

exceptions.

As the field of emergency medicine

evolved, treatments were developed for

conditions such as head trauma, stroke,

and heart attack that were previously

considered hopeless. The need for the

development of treatment methods

where only unsatisfactory methods

existed and to determine the

effectiveness of new treatments was

recognized in the medical community.

The importance of obtaining informed

consent as an integral part of the

protection of human subjects was also

recognized. The Subcommittee on

Regulation, Business Opportunities, and

Technology of the House Committee on

Small Business, held a hearing on May

23, 1994, that addressed problems

encountered in securing informed

consent of subjects in clinical trails of

investigational drugs and medical

devices. A coalition of acute

resuscitation and critical care

researchers held an October 1994
Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Rules and Regulations 46199

conference on the issues involved. In

January 1995, FDA and the National

Institutes of Health cosponsored a

public forum on informed consent in

clinical research conducted in

emergency circumstances. In the

Federal Register of September 21, 1995

(60 FR 49086), FDA proposed to amend

its regulations to provide an exception

to informed consent for research of

emergency treatment for persons with

acute and unpredictable life-threatening

illnesses. After analysis of over 90

comments, in the Federal Register

October 2, 1996 (61 FR 51498), FDA

published the final rule (§ 50.24) that is

the subject of this public meeting. The

Department of Health and Human

Services simultaneously published (61

FR 51531, October 2, 1996) a

functionally equivalent waiver of its

human subject protection regulations

(45 CFR part 46).

The exception to the normal

requirements for obtaining informed

consent (61 FR 51531) is narrow in

scope and available for research

conducted in emergency circumstances

on treatments for life-threatening

conditions. The exception requires

additional protections beyond those

provided for human research subjects in

other research.

While § 50.24 provides specific

requirements for use of the exception to

informed consent, FDA recognized that

local conditions vary throughout the

Nation, and placed considerable

discretion and responsibility in the

IRB’s that will review proposed studies,

the clinical investigators who will

conduct the studies, and the sponsors

who will initiate the studies and utilize

the results. Questions have arisen as to

the appropriate methods to satisfy the

regulatory requirements imposed for use

of the exception.

At the public meeting, participants

will examine the methods of providing

the additional protections required

when utilizing the exception to

informed consent. Presentations and

discussions will address the specific

measures required. Participants will be

provided opportunities to share their

views and information regarding

protocol design, study conduct, and

experiences of clinical research

conducted or planned under the

exception to informed consent.

On September 29, 1997, the meeting

will open with discussions describing

how the final rule was developed, what

FDA expects to receive from sponsors,

and how to determine whether clinical

equipoise exists between standard

therapy and an investigational

procedure. Representatives of a study

sponsor will describe how that study

has been implemented at multiple study

sites. A panel of experts will discuss

issues related to consultation with

representatives of the community where

the research will be conducted and from

which subjects will be drawn, if

different, and disclosure of the research

to the community. A session of open

discussion will provide an opportunity

for audience participation. A second

panel of experts will discuss issues

related to procedures for seeking

consent from a subject’s legal

representative, and documenting the

attempts to obtain consent. A session of

open discussion will follow.

On September 30, 1997, the meeting

will open with presentations describing

the function and operation of data safety

monitoring boards that are required for

studies under the final rule, as well as

the other requirements of the final rule.

A representative of a study sponsor will

describe the preparation for and

coordination of a multi-site study. A

panel of experts will discuss the

circumstances in which it is appropriate

to use the final rule, and how the

different parties involved should

interact with each other to produce a

useful study. A session of open

discussion will follow and then the

meeting will conclude.

All sessions of the meeting are open

to the public; however, open seating is

limited to 300. Those persons interested

in attending should submit registration

information, including name,

organization name, address, telephone

and fax numbers to the contact listed in

this document. There is no registration

fee for this public meeting, but

advanced registration is recommended,

as preregistrants will have preference if

seating capacity is exceeded. Interested

parties are encouraged to register early

because space is limited.

Interested persons may, on or before

October 31, 1997, submit to the Dockets

Management Branch (address above)

written comments regarding the

workshop. 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.

Additional information as well as a

registration form is also available at

FDA’s website at http.//www.fda.gov.

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–23123 Filed 8–29–97; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[MD040–3018a; FRL–5881–6]

Approval and Promulgation of Air

Quality Implementation Plans;

Maryland; Control of Volatile Organic

Compound Emissions From Sheet-Fed

and Web Lithographic Printing and

Paper Coatings

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is approving the State

Implementation Plan (SIP) revisions

submitted by the State of Maryland on

July 11, 1995. These revisions establish

volatile organic compound (VOC)

emission reduction requirements for

sheet-fed and web lithographic printing

operations, and paper, fabric, vinyl, and

other plastic coating operations

throughout the State of Maryland under

COMAR 26.11.19 Volatile Organic

Compounds from Specific Processes.

EPA is also approving the

administrative changes to Maryland’s

regulations for VOC emissions from

specific processes. The intended effect

of this action is to approve these

provisions into the Maryland SIP, in

accordance with the SIP submittal and

revision provisions of the Clean Air Act

(the Act). This action is being taken

under section 110 of the Act.

EFFECTIVE DATE: This final rule is

effective November 3, 1997 unless by

October 2, 1997, adverse or critical

comments are received. If the effective

date is delayed, timely notice will be

published in the Federal Register.

ADDRESSES: Comments may be mailed to

David L. Arnold, Chief, Ozone/CO and

Mobile Sources Section, Mailcode

3AT21, U.S. Environmental Protection

Agency, Region III, 841 Chestnut

Building, Philadelphia, Pennsylvania

19107. Copies of the documents relevant

to this action are available for public

inspection during normal business

hours at the Air, Radiation, and Toxics

Division, U.S. Environmental Protection

Agency, Region III, 841 Chestnut

Building, Philadelphia, Pennsylvania

19107 and the Maryland Department of

the Environment, 2500 Broening

Highway, Baltimore, Maryland 21224.

FOR FURTHER INFORMATION CONTACT:

Carolyn M. Donahue, (215) 566–2095, at

the EPA Region III office address listed

above, or via e-mail at

donahue.carolyn@epamail.epa.gov.

While information may be requested via

e-mail, comments must be submitted in

writing to the above Region III address.