[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availability of a revised draft guidance for industry entitled ``PET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
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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