[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Pages 6144-6146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0060]


Positron Emission Tomography; Notice of Public Meeting; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to assist applicants in preparing new drug applications (NDAs) 
or abbreviated new drug applications (ANDAs) for fludeoxyglucose (FDG) 
18 injection, ammonia N 13 injection, and sodium fluoride F 18 
injection used in positron emission tomography (PET) imaging. By 
December 12, 2011, FDA expects all producers of PET drugs in commercial 
clinical use to submit applications for marketing approval. FDA 
recognizes that many PET drug producers are unfamiliar with the drug 
approval process. Accordingly, FDA is holding this public meeting to 
discuss the drug approval process and FDA's general inspection process. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a revised draft guidance for industry entitled ``PET 
Drug Applications--Content and Format for NDAs and ANDAs'' that will be 
used at the meeting to explain the drug approval process.

DATES: The meeting will be held on March 2, 2011, from 8:30 p.m. to 5 
p.m. See section IV of this document for information on how to register 
for and attend the meeting. Submit either electronic or written 
comments on this document by March 7, 2011.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993-
0002.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Giaquinto, Food and Drug Administration, Center for Drug 
Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, rm. 6164, 
Silver Spring, MD 20993-0002, 301-796-3416, FAX: 301-847-8752, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, President Clinton signed the Food and Drug 
Administration Modernization Act of 1997 (Pub. L. 105-115) (FDAMA) into 
law. Section 121(c) of FDAMA directs FDA to regulate PET drugs. Section 
121 requires FDA to develop appropriate procedures for the approval of 
PET drugs as well as current good manufacturing practice (CGMP) 
requirements for such drugs; to consult with patient advocacy groups, 
professional associations, manufacturers, and persons licensed to make 
or use PET drugs in the process of establishing these procedures and 
requirements; and to not require the submission of NDAs or ANDAs for 
compounded PET drugs that are not adulterated as described in the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) for a period of 4 
years after the date of enactment of FDAMA or 2 years after the date 
FDA adopts special approval procedures and CGMP

[[Page 6145]]

requirements for PET drugs, whichever is longer.
    Beginning in 1997, FDA took a series of actions to regulate PET 
drugs.
     The Agency conducted several public meetings with various 
representatives of an industry trade association, the Academy for 
Molecular Imaging (formerly the Institute for Clinical PET (ICP)), and 
other interested persons to discuss FDA proposals for PET drug approval 
procedures and CGMP requirements. Because certain PET drugs have been 
used clinically for a number of years, FDA conducted its own review of 
the published literature \1\ to evaluate the safety and effectiveness 
of the PET drugs in widespread use for certain indications to 
facilitate the process of submitting applications for these products.
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    \1\ As stated in FDA guidance for industry entitled ``Providing 
Clinical Evidence of Effectiveness for Human Drugs and Biological 
Products,'' FDA may, in certain circumstances, rely on published 
literature alone to support the approval of a new drug product under 
section 505 of the FD&C Act (21 U.S.C. 355).
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     The Agency discussed its preliminary findings on the 
safety and effectiveness of FDG F 18 injection (for the assessment of 
malignancy as well as left ventricular myocardial viability) and 
ammonia N 13 injection (for assessing myocardial perfusion) with the 
ICP and other interested persons at public meetings on November 17, 
1998, and February 18 and 19, 1999.
     On June 28 and 29, 1999, the Agency presented its findings 
to its Medical Imaging Drugs Advisory Committee (Advisory Committee). 
The Advisory Committee concluded that FDG F 18 injection and ammonia N 
13 injection can be considered safe and effective for the indications 
noted previously, although it recommended some revisions to the wording 
of the indications proposed by FDA.
     In a notice published in the Federal Register of March 10, 
2000 (65 FR 12999), FDA presented its findings of safety and 
effectiveness for the PET drugs studied for certain indications and 
described the types of applications that can be submitted for FDG F 18 
injection, ammonia N 13 injection, and sodium fluoride F 18 injection 
used in PET imaging. These findings fulfill the requirement to develop 
appropriate approval procedures for these PET drugs.
     In the Federal Register of April 1, 2002, FDA published a 
preliminary draft proposed CGMP regulation (67 FR 15344) and a draft 
guidance on CGMP requirements (67 FR 15404) for public comment; in the 
Federal Register of September 20, 2005, FDA published a proposed rule 
(70 FR 55038) and revised draft guidance (70 FR 55145), to solicit 
additional public input; in the Federal Register of December 10, 2009 
(74 FR 65409), after carefully considering all public input, FDA 
published a final CGMP regulation, triggering the 2-year time period 
for PET drug producers to submit an NDA or ANDA for any PET drug used 
clinically.
    FDA is in the process of establishing a time line for completion of 
the review of PET drug applications and approval determinations. PET 
drug application submissions must be received by the Agency on or 
before December 12, 2011. Applicants may continue to use a PET drug 
during the time of our NDA or ANDA review. FDA intends to exercise 
enforcement discretion regarding unapproved PET drugs while submissions 
are reviewed. However, FDA expects that by December 9, 2015, all PET 
drugs in commercial clinical use (i.e., not used under a Radioactive 
Drug Research Committee or an investigational new drug application 
(IND)) will be used under approved applications and does not intend to 
exercise enforcement discretion beyond that date.

II. PET Guidances

    Elsewhere in this issue of the Federal Register, FDA is making 
available a revised draft guidance for industry entitled ``PET Drug 
Applications--Content and Format for NDAs and ANDAs.'' The draft 
guidance provides background information on the regulation of PET 
drugs; makes recommendations to help producers decide whether to submit 
an NDA or ANDA for their PET drug; includes a description of the 
content and format for both an NDA and an ANDA; and provides text that 
may be used in the applications.
    More information on CGMP requirements for PET drugs may be found in 
the guidance for industry entitled ``PET Drugs--Current Good 
Manufacturing Practice (CGMP)'' issued December 2009, available at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070306.pdf.

III. Purpose and Scope of the Meeting

    The purpose of this meeting is to assist applicants in preparing 
NDA and ANDA submissions for specific PET drugs: FDG F 18 injection, 
ammonia N 13 injection, and sodium fluoride F 18 injection. FDA will 
present information designed to assist PET drug producers with the 
entire application process. FDA expects to discuss the following topics 
at the public meeting:
     Whether to submit an NDA or ANDA,
     Preparing and submitting an NDA,
     Preparing and submitting an ANDA,
     Bioequivalence requirements,
     Labeling,
     User fees,
     Drug Master Files,
     Compliance with CGMPs, and
     INDs.
    The Office of Critical Path Programs is preparing a separate 
training session on electronic submission of applications and 
electronic drug registration and listing for PET drug producers. The 
training will be offered via webinar and will be made available at 
several different times. Therefore, these topics will not be addressed 
at the March 2, 2011, meeting. For more information on this training 
and its availability, please contact Elizabeth Giaquinto (see FOR 
FURTHER INFORMATION CONTACT).

IV. Registration and Attendance

    The FDA Conference Center at the White Oak location is a Federal 
facility with security procedures and limited seating, therefore early 
arrival is encouraged. Attendance is free and will be on a first-come, 
first-served basis. For more information on meeting registration, 
contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION CONTACT).
    If you need special accommodations because of a disability, please 
contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION CONTACT) at 
least 7 days before the meeting.
    A live Web cast of this meeting will be available on the Agency's 
Web site at https://collaboration.fda.gov/petdrugs/ on the day of the 
meeting. For more information on the Web cast and Connect Pro meeting, 
please contact Elizabeth Giaquinto (see FOR FURTHER INFORMATION 
CONTACT).

V. Comments

    Regardless of attendance at the public meeting, interested persons 
may submit to the Division of Docket Managements (see ADDRESSES) either 
electronic or written comments on the topics discussed in this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be

[[Page 6146]]

accessible at http://www.regulations.gov. It may be viewed at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be 
available in either hardcopy or on CD-ROM, after submission of a 
Freedom of Information request. Written requests are to be sent to 
Division of Freedom of Information (HFI-35), Office of Management 
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, 
Rockville, MD 20857.

    Dated: January 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2313 Filed 2-2-11; 8:45 am]
BILLING CODE 4160-01-P