8980 Federal Register / Vol. 46, No. 17 / Tuesday, January 27, 1981 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 77N-0350]

Protection of Human Research

Subjects; Clinical Investigations Which

May Be Reviewed Through Expedited

Review Procedure Set forth in FDA

Regulations

AGENCY: Food and Frug Administration.

ACTiOm Notice.

SUMMARY: This notice contains a list of

research activities which institutional

review boards may review through the

expedited review procedures set forth in

FDA regulations for the protection of

human research subjects.

FOR FURTHER INFORMATION CONTACT.

John C. Petricciani, Office of the

Commissioner (HFB-4), Food and Drug

Administration, 8800 Rockville Pike,

Bethesda, MD 20205, 301-498-9320.

SUPPLEMENTARY INFORMATION:

Elsewhere in this issue of the Federal

Register, the Fobd and Drug

Administration (FDA) is publishing final

regulations establishing standards for

institutional review boards (IRBs) for

clinical investigations relating to the

protection of human subjects in

research. Section 56.110 (21 CFR 56.110]

of the final IRB regulations provides that

the agency will publish in the Federal

Register a list of categories of research

activities, involving n 4more than

minimal risk, that ihay be reviewed by

an IRB through expedited review

procedures. This notice is published in

accordance with § 56.110.

The agency concludes that research

activities with human subjects involving

no more than minimal risk and involving

one or more of the following categories

(carried out through standard methods),

may be reviewed by an IRB through the

expedited review procedure authorized

in § 56.110.

(1) Collection of hair and nail

clippings in a non-disfiguring manner of

deciduous teeth; and of permanent teeth

if patient care indicates a need for

extraction.

(2) Collection of excreta and external

secretions including sweat and

uncannulated saliva; of placenta at

delivery; and of amniotic fluid at the

time of rupture of the membrane before

or during labor.

(3) Recording of data from subjects

who are 18 years of age of older using

noninvasive procedures routinely

employed in clinical practice. This'

category includes the use of physical

sensors that are applied either to the

surface of the body or at a distance and

do not involve input of matter or

significant amounts of energy into the

subject or an invasion of the subject's

privacy. It also includes such procedures

as weighting, electrocardiography,

electroencephalography, thermography,

detection of naturally occurring

radioactivity, diagnostic echography,

and electroretinography. This category

does not include exposure to

electromagnetic radiation outside the

visible range (for example, x-rays or

microwaves).

(4)Collection of blood samies-by

venipuncture, in amounts not exceeding

450 milliliters in an eight-week period

and no more often than two times per

week, from subjects who are 18 years of

age or older and who are in good health

and not pregnant.

(5) Collection of both supra- and

subgingival dental plaque and calculus,

provided the procedure is not more

invasive than routine prophylactic

scaling of the teeth, and the process is

accomplished in accordance with

accepted prophylactic techniques.

(6) Voice recordings made for

research purposes such as investigations

of speech defects.

(7) Moderate exercise by healthy

volunteers.

(8) The study of existing data,

documents, records, pathological

specimens, or diagnostic specimens.

.(9) Research on drugs or devices for

which an investigational new drug

exemption or an investigational device

exemption is not required.

This list will be amended as

appropriate and a current list will be

published periodically to the Federal

Register.

Dated: January,19, 1981.

Jere E. Goyan,

Commissioner of Food andDrugs.

[FR Doc. 81-2690 Filed 1-21-81; 3'59 pm]

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