Document ID: FDA-2011-N-0002-0083
Agency: fda
Document Type: Rule
Title: Medical Imaging Drugs Advisory Committee; Re-establishment
Posted Date: 2011-07-29T04:00Z

[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Rules and Regulations]
[Pages 45402-45403]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19064]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2010-N-0002]

Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-
Establishment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the re-
establishment of the Medical Imaging Drugs Advisory Committee in FDA's 
Center for Drug Evaluation and Research. This rule amends the current 
language for the Medical Imaging Drugs Advisory Committee in the 
Agency's list of standing advisory committees in FDA's regulations.

DATES: Effective date: This rule is effective August 5, 2011. 
Applicability date: Authority for the committee being established will 
end on May 18, 2013, unless the Commissioner of Food and Drugs (the 
Commissioner) formally determines that renewal is in the public 
interest.

FOR FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, Division of Advisory 
Committee and Consultant Management, Bldg. 31, rm. 2417, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-
847-8533 or e-mail: MIDAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the Federal Advisory Committee Act of 
October 6, 1972 (Pub. L. 92-463 (5 U.S.C. app.2)); section 1004 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 394); and 21 CFR 
14.40(b), FDA is announcing the establishment of the Medical Imaging 
Drugs Advisory Committee by the Commissioner. The Committee advises the 
Commissioner and designee in discharging responsibilities as they 
relate to helping to ensure safe and effective drugs for human use and, 
as required, any other product for which the Food and Drug 
Administration has regulatory responsibility. The Committee reviews and 
evaluates data concerning the safety and effectiveness of marketed and 
investigational human drug products for use in diagnostic and 
therapeutic procedures using radioactive pharmaceuticals and contrast 
media used in diagnostic radiology and makes appropriate 
recommendations to the Commissioner.
    The Medical Imaging Drugs Advisory Committee will be composed of a 
core of 12 voting members including the Chair. Members and the Chair 
are selected by the Commissioner or designee from among authorities 
knowledgeable in the fields of nuclear medicine, radiology, 
epidemiology or statistics, and related specialties. Members will be 
invited to serve for overlapping terms of up to 4 years. Almost all 
non-Federal members of this committee serve as Special Government 
Employees. The core of voting members may include one technically 
qualified member, selected by the Commissioner or designee, who is 
identified with consumer interests and is recommended by either a 
consortium of consumer-oriented organizations or other interested 
persons. In addition to the voting members, the Committee may include 
one non-voting member who is identified with industry interests.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
notices requesting nominations for membership of members as well as a 
consumer and industry representative on this committee.
    Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), 
the agency finds good cause to dispense with notice and public comment 
procedures and to proceed to an immediate effective date on this rule. 
Notice and public comment and a delayed effective date are unnecessary 
and are not in the public interest as this final rule merely adds the 
name of the Medical Imaging Drugs Advisory Committee, already 
established by charter, to the list of standing advisory committees in 
21 CFR 14.100.
    Therefore the Agency is amending 21 CFR 14.100(a) as set forth 
below.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority:  5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155.

[[Page 45403]]

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2. Section 14.100 is amended by revising paragraph (c)(15) to read as 
follows:

Sec.  14.100  List of standing advisory committees.

* * * * *
    (c) * * *
    (15) Medical Imaging Drugs Advisory Committee.
    (i) Date established: May 18, 2011.
    (ii) Function: Reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in diagnostic and therapeutic procedures using radioactive 
pharmaceuticals and contrast media used in diagnostic radiology.
* * * * *

    Dated: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19064 Filed 7-28-11; 8:45 am]
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