[Federal Register Volume 71, Number 246 (Friday, December 22, 2006)]
[Notices]
[Pages 77034-77035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0172]


Guidance for Clinical Investigators, Institutional Review Boards, 
and Sponsors; Process for Handling Referrals to Food and Drug 
Administration Under 21 CFR 50.54: Additional Safeguards for Children 
in Clinical Investigations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance for Clinical 
Investigators, Institutional Review Boards, and Sponsors; Process for 
Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for 
Children in Clinical Investigations.'' This guidance is intended to 
assist clinical investigators, Institutional Review Boards (IRBs), 
sponsors, and other interested parties in understanding FDA's process 
for handling clinical investigations that include children as subjects 
and that

[[Page 77035]]

have been referred to FDA for review under FDA regulations on 
additional safeguards for children in clinical investigations. The 
guidance describes the procedures FDA generally intends to follow in 
handling clinical investigations referred for review under Sec.  50.54 
(21 CFR 50.54) and in reaching final determinations in accordance with 
these regulations. The guidance announced in this notice finalizes the 
draft guidance of the same title dated May 2006.

DATES: General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Policy (HF-11), Office of the Commissioner, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your 
requests. Submit telephone requests to 800-835-4709 or 301-827-1800. 
Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3360.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled 
``Guidance for Clinical Investigators, Institutional Review Boards, and 
Sponsors; Process for Handling Referrals to FDA Under 21 CFR 50.54: 
Additional Safeguards for Children in Clinical Investigations.'' FDA 
issued 21 CFR part 50, subpart D, ``Additional Safeguards for Children 
in Clinical Investigations,'' (subpart D) as an interim final rule on 
April 24, 2001 (66 FR 20598). Under these regulations, an IRB must 
review clinical investigations involving children as subjects and 
covered by subpart D and approve only those clinical investigations 
that satisfy the criteria described in Sec. Sec.  50.51, 50.52, or 
50.53, as well as the conditions of all other applicable sections in 
subpart D.
    Under Sec.  50.54, if an IRB does not believe that a clinical 
investigation within the scope described in Sec. Sec.  50.1 and 56.101 
(21 CFR 56.101) and involving children as subjects meets the 
requirements of Sec. Sec.  50.51, 50.52, or 50.53, the clinical 
investigation may proceed only if:
     (1) The IRB finds and documents that the clinical 
investigation presents a reasonable opportunity to further the 
understanding, prevention, or alleviation of a serious problem 
affecting the health or welfare of children; and
     (2) The Commissioner of Food and Drugs, after consultation 
with a panel of experts in pertinent disciplines (for example: science, 
medicine, education, ethics, law) and following opportunity for public 
review and comment, determines either of the following:
     That the clinical investigation in fact satisfies the 
conditions of Sec.  50.51, 50.52, or 50.53, as applicable, or
     That the following conditions are met:
     The clinical investigation presents a reasonable 
opportunity to further the understanding, prevention, or alleviation of 
a serious problem affecting the health or welfare of children;
     The clinical investigation will be conducted in accordance 
with sound ethical principles; and
     Adequate provisions are made for soliciting the assent of 
children and the permission of their parents or guardians as set forth 
in Sec.  50.55.
    The guidance describes the procedures FDA generally will follow in 
handling clinical investigations referred for review under Sec.  50.54 
and in reaching final determinations under that regulation. The 
guidance is based in part on FDA's experience to date with such 
referrals. The Department of Health and Human Services (HHS) has human 
subject protection regulations that also govern research involving 
children as subjects and supported or conducted by HHS. (See 45 CFR 
part 46, subpart D.) The guidance also addresses situations in which a 
clinical investigation is subject to both 21 CFR 50.54 and 45 CFR 
46.407.
    In the Federal Register of May 10, 2006 (71 FR 27264), FDA 
announced the availability of the draft guidance of the same title 
dated May 2006. FDA received a few comments on the draft guidance and 
those comments were considered as the guidance was finalized.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the process for handling referrals to FDA 
underSec.  50.54. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
information required under Sec.  50.54 is a recordkeeping requirement. 
IRB recordkeeping requirements are set forth in FDA regulations on IRBs 
(21 CFR part 56) at Sec.  56.115. The collection of information in 
Sec.  56.115 has been approved under OMB Control No. 0910-0130. 
Although FDA had included an analysis of the estimated annual reporting 
burden in the notice of availability for the draft guidance (71 FR 
27264), that analysis made clear that, based on the agency's experience 
to date with the regulation addressed in the guidance, FDA only expects 
approximately five respondents per year to submit information to the 
agency under the guidance. Accordingly, FDA has concluded that, under 5 
CFR 1320.3(c), there is no collection of information associated with 
this guidance.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm orhttp://www.fda.gov/ohrms/dockets/default.htm.

    Dated: December 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21950 Filed 12-21-06; 8:45 am]
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