[Federal Register Volume 64, Number 44 (Monday, March 8, 1999)]
[Rules and Regulations]
[Pages 10942-10943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50 and 812

[Docket No. 96N-0158]
RIN 0910-AA60


Protection of Human Subjects; Informed Consent; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending a final 
rule that appeared in the Federal Register of October 2, 1996 (61 FR 
51498) on informed consent. The document was published with some 
inadvertent errors in the codified section. This document corrects 
those errors to ensure the accuracy and consistency of the agency's 
regulations.

EFFECTIVE DATE: March 8, 1999.
FOR FURTHER INFORMATION CONTACT: Bonnie M. Lee, Office of the Executive 
Secretariat (HF-40), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20852, 301-827-4450.

SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday, 
October 2, 1996 (61 FR 51498), an amendment for Sec. 50.20 (21 CFR 
50.20) was inadvertently omitted. Section 50.20 now provides for two 
exceptions to obtaining informed consent; one exception is contained in 
Sec. 50.23 (21 CFR 50.23) and the other is contained Sec. 50.24 (21 CFR 
50.24). Accordingly this document conforms Sec. 50.20 to the final 
regulations. Additionally, an amendment for Sec. 812.47(b) (21 CFR 
812.47(b)) inadvertently omitted commas which could cause confusion in 
understanding the meaning of the last sentence in that paragraph. 
Accordingly, FDA is amending the last sentence in Sec. 812.47(b) to 
include two commas so that it will state ``The sponsor promptly shall 
provide this information in writing to FDA, investigators who are asked 
to participate in this or a substantially equivalent clinical 
investigation, and other IRB's that are asked to review this or a 
substantially equivalent investigation.'' Also, the final rule on 
informed consent amended the Investigational New Drug Application (IND) 
regulations and the Investigational Device Exemption (IDE) regulations. 
In the Federal Register of June 16, 1997, FDA amended its IND 
regulations to clarify that, within 30 days after receipt of an IND for 
any clinical investigation involving an exception from informed 
consent, FDA will provide a written determination as to whether the 
investigation may begin. The agency inadvertently omitted a conforming 
amendment for the IDE regulations in Sec. 812.20 (21 CFR 812.20). 
Current IDE regulations at Sec. 812.20(a)(4)(i) require sponsors to 
submit a separate IDE for any clinical investigation involving an 
exception from informed consent under Sec. 50.24. This requirement is 
to ensure that FDA has an opportunity to review the protocol and 
supporting information before the investigation begins. Section 
812.20(a)(4)(i) also provides that the clinical investigation may not 
proceed without prior written authorization from FDA. The statement in 
Sec. 812.20(a)(4)(i) that ``FDA shall provide such written 
authorization 30 days after FDA receives the IDE or earlier'' might be 
misread as suggesting that the agency may only grant permission for 
investigations to begin. To clarify the agency's intent, FDA is 
amending the last sentence in Sec. 812.20(a)(4)(i) to state that ``FDA 
shall provide a written determination 30 days after FDA receives the 
IDE or earlier.''

List of Subjects

21 CFR Part 50

    Human research subjects, Prisoners, Reporting and recordkeeping 
requirements, Safety.

21 CFR Part 812

    Health records, Medical devices, 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, 21 CFR parts 
50 and 812 are amended as follows:

PART 50--PROTECTION OF HUMAN SUBJECTS

    1. The authority citation for 21 CFR part 50 is revised to read as 
follows:

    Authority: 21 U.S.C. 321, 346, 346a, 348, 352, 353, 355, 360, 
360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-
263n.

    2. Section 50.20 is amended by revising the first sentence to read 
as follows:


Sec. 50.20  General requirements for informed consent.

    Except as provided in Secs. 50.23 and 50.24, no investigator may 
involve a human being as a subject in research covered by these 
regulations unless the investigator has obtained the legally effective 
informed consent of the subject or the subject's legally authorized 
representative. * * *

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

    3. The authority citation for 21 CFR part 812 is revised to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 
262, 263b-263n.

    4. Section 812.20 is amended by revising the last sentence of 
paragraph (a)(4)(i) to read as follows:


Sec. 812.20  Application.

    (a) * * *
    (4)(i) * * * FDA shall provide a written determination 30 days 
after FDA receives the IDE or earlier.
 * * * * *
    5. Section 812.47 is amended by revising the last sentence of 
paragraph (b) to read as follows:

[[Page 10943]]

Sec. 812.47   Emergency research under Sec. 50.24 of this chapter.

* * * * *
    (b) * * * The sponsor promptly shall provide this information in 
writing to FDA, investigators who are asked to participate in this or a 
substantially equivalent clinical investigation, and other IRB's that 
are asked to review this or a substantially equivalent investigation.

    Dated: March 1, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-5522 Filed 3-5-99; 8:45 am]
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