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
66531Federal Register / Vol. 60, No. 246 / Friday, December 22, 1995 / Proposed Rules
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