66530 Federal Register / Vol. 60, No. 246 / Friday, December 22, 1995 / Proposed Rules

ICAO Considerations

As part of this proposal relates to

navigable airspace outside the United

States, this notice is submitted in

accordance with the International Civil

Aviation Organization (ICAO)

International Standards and

Recommended Practices.

Applicability of International

Standards and Recommended Practices

by the Air Traffic Rules and Procedures

Service, FAA, in areas outside domestic

airspace of the United States is governed

by Article 12 of, and Annex 11 to, the

Convention on International Civil

Aviation, which pertains to the

establishment of air navigational

facilities and services necessary to

promote the safe, orderly, and

expeditious flow of civil air traffic.

Their purpose is to ensure that civil

aircraft operations on international air

routes are carried out under uniform

conditions designed to improve the

safety and efficiency of air operations.

The International Standards and

Recommended Practices in Annex 11

apply in those parts of the airspace

under the jurisdiction of a contracting

state, derived from ICAO, wherein air

traffic services are provided and also

whenever a contracting state accepts the

responsibility of providing air traffic

services over high seas or in airspace of

undetermined sovereignty. A

contracting state accepting such

responsibility may apply the

International Standards and

Recommended Practices in a manner

consistent with that adopted for

airspace under its domestic jurisdiction.

In accordance with Article 3 of the

Convention on International Civil

Aviation, Chicago, 1944, state aircraft

are exempt from the provisions of

Annex 11 and its Standards and

Recommended Practices. As a

contracting state, the United States

agreed by Article 3(d) that its state

aircraft will be operated in international

airspace with due regard for the safety

of civil aircraft.

Since this action involves, in part, the

designation of navigable airspace

outside the United States, the

Administrator is consulting with the

Secretary of State and the Secretary of

Defense in accordance with the

provisions of Executive Order 10854.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 71 as

follows:

PART 71—[AMENDED]

1. The authority citation for part 71

continues to read as follows:

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

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

1963 Comp., p. 389; 14 CFR 11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9C, Airspace

Designations and Reporting Points,

dated August 17, 1995, and effective

September 16, 1995, is amended as

follows:

Paragraph 5000—Class D Airspace

* * * * *

AWP CQ D Saipan Island, CQ [New]

Saipan International Airport, CQ

(Lat. 15°07′08′′N, long. 145°43′46′′E)

Saipan RBN (lat. 15°06′41′′N, long.

145°42′37′′E)

That airspace extending upward from the

surface to and including 2,500 feet MSL

within a 4.3-mile radius of Saipan

International Airport. This Class D airspace

area is effective during the specific dates and

times established in advanced by a Notice to

Airmen. The effective date and time will

thereafter be continuously published in the

Airport/Facility Directory, Pacific Chart

Supplement.

* * * * *

Paragraph 6004—Class E airspace areas

designated as an extension to a Class D

surface area

* * * * *

AWP CQ E4 Saipan Island, CQ [New]

Saipan International Airport, CQ

(Lat. 15°07′08′′N, long. 145°43′46′′E)

Saipan RBN (lat. 15°06′41′′N, long.

145°42′37′′E)

That airspace extending upward from the

surface within a 4.3-mile radius of Saipan

International Airport and within 2.6 miles

each side of the Saipan RBN 264° bearing,

extending from the 4.3-mile radius to 7.4

miles west of the Saipan RBN and within 1.8

miles each side of the Saipan RBN 248°

radial, extending from the 4.3-mile radius to

7.4 miles west of the Saipan RBN and within

1.8 miles each side of the Saipan RBN 068°

radial, extending from the 4.3-mile radius to

6.5 miles east of the Saipan International

Airport. This Class E airspace area is effective

during the specific dates and times

established in advanced by a Notice to

Airmen. The effective date and time will

thereafter be continuously published in the

Airport/Facility Directory, Pacific Chart

Supplement.

* * * * *

Issued in Washington, DC, on December

12, 1995.

Harold W. Becker,

Manager, Airspace-Rules and Aeronautical

Information Division.

[FR Doc. 95–31202 Filed 12–21–95; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50 and 312

[Docket No. 95N–0359]

Protection of Human Subjects;

Informed Consent

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its current informed consent

regulations to require that the written

consent form signed by the subject or

the subject’s legally authorized

representative, be dated by the subject

or the subject’s legally authorized

representative at the time consent is

given. FDA is proposing this

requirement because the agency has had

problems on occasion verifying that

informed consent was obtained from a

research subject prior to participation in

a study because the consent document

was not dated. The agency believes that

by explicitly requiring that the consent

form be dated at the time it is signed,

the agency will be able to help ensure

that informed consent was, in fact,

obtained prior to entry into the study as

required by FDA regulations. FDA is

also proposing to amend its regulation

on case histories to clarify what

adequate case histories include.

DATES: Written comments by March 21,

1996.

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: Glen

D. Drew, Office of Health Affairs (HFY–

20), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–1382.

SUPPLEMENTARY INFORMATION:

I. Description of the Proposed Rule

Except as provided in FDA

regulations, no investigator may involve

a human being as a subject in research

covered by part 50 (21 CFR part 50)

unless the investigator has obtained the

legally effective informed consent of the

subject or the subject’s legally

authorized representative. Section 50.20

requires the investigator to seek

informed consent only under

circumstances that provide the

prospective subject or the representative

sufficient opportunity to consider

whether or not to participate and that
Federal Register / Vol. 60, No. 246 / Friday, December 22, 1995 / Proposed Rules 66531

minimize the possibility of coercion or

undue influence. In past audits of

clinical investigations, FDA has had

problems on occasion verifying that

consent was obtained prior to

participation in the study because a

number of the consent documents were

not dated. By explicitly requiring that

the consent form be dated at the time it

is signed, the agency will be able to help

ensure that informed consent was

obtained prior to entry into the study

and will be able to verify that the

investigator has fulfilled his or her

obligation. Thus, FDA is proposing to

amend § 50.27(a) to explicitly require

that the consent form be dated by the

subject or the subject’s legally

authorized representative at the time

that it is signed.

II. Request for Comments

Interested persons may, on or before

March 21, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. 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.

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) 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.

IV. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(Pub. L. 96–354). 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). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. This rule simply adds a

requirement that consent forms be dated

at the time that they are signed in order

to permit the agency to verify that

informed consent is obtained prior to an

individual’s entry into a research study.

Because the majority of consent forms

are currently dated at the time that they

are signed, the agency certifies that the

proposed rule will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

V. Clarifying Amendments

Along with this proposal to require

that consent forms be dated at the time

they are signed, FDA believes that a

number of related changes to the

regulations for human drugs and

biologics are warranted. FDA is

proposing to revise § 312.53(c)(1)(vi)(d)

(21 CFR 312.53(c)(1)(vi)(d)) to expressly

recognize that the informed consent

referred to be in accordance with 21

CFR part 50 and that institutional

review board review and approval

referred to be in accordance with 21

CFR part 56. Also, FDA is proposing to

revise § 312.62(b) (21 CFR 312.62(b)) to

clarify that adequate case history

records include the case report forms

and supporting data, including, for

example, signed and dated consent

forms and medical records.

List of Subjects

21 CFR Part 50

Human research subjects, Informed

consent, Prisoners, Reporting and

recordkeeping requirements, Safety.

21 CFR Part 312

Drugs, Exports, Imports,

Investigations, Labeling, Medical

research, Reporting and recordkeeping

requirements.

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 50 and 312 be amended as

follows:

PART 50—PROTECTION OF HUMAN

SUBJECTS

1. The authority citation for 21 CFR

part 50 continues to read as follows:

Authority: Secs. 201, 406, 408, 409, 502,

503, 505, 506, 507, 510, 513–516, 518–520,

701, 721, 801 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 346, 346a, 348,

352, 353, 355, 356, 357, 360, 360c–360f,

360h–360j, 371, 379e, 381); secs. 215, 301,

351, 354–360F of the Public Health Service

Act (42 U.S.C. 216, 241, 262, 263b–263n).

2. Section 50.27 is amended by

revising paragraph (a) to read as follows:

§ 50.27 Documentation of informed

consent.

(a) Except as provided in § 56.109(c),

informed consent shall be documented

by the use of a written consent form

approved by the IRB and signed and

dated by the subject or the subject’s

legally authorized representative at the

time of consent. A copy shall be given

to the person signing the form.

* * * * *

PART 312—INVESTIGATIONAL NEW

DRUG APPLICATION

3. The authority citation for 21 CFR

part 312 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 331, 351,

352, 353, 355, 356, 357, 371); sec. 351 of the

Public Health Service Act (42 U.S.C. 262).

4. Section 312.53 is amended by

revising paragraph (c)(1)(vi)(d) to read

as follows:

§ 312.53 Selecting investigators and

monitors.

* * * * *

(c) * * *

(1) * * *

(vi) * * *

(d) Will inform any patients, or any

persons used as controls, that the drugs

are being used for investigational

purposes and will ensure that the

requirements relating to obtaining

informed consent (21 CFR part 50) and

institutional review board review and

approval (21 CFR part 56) are met;

* * * * *

5. Section 312.62 is amended by

revising paragraph (b) to read as follows:

§ 312.62 Investigator recordkeeping and

record retention.

* * * * *

(b) Case histories. An investigator is

required to prepare and maintain

adequate and accurate case histories

that record all observations and other

data pertinent to the investigation on

each individual treated with the

investigational drug or employed as a

control in the investigation. Case

histories include the case report forms

and supporting data including, for

example, signed and dated consent

forms and medical records.

* * * * *

Dated: December 12, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–31154 Filed 12–21–95; 8:45 am]

BILLING CODE 4160–01–F