[Federal Register Volume 62, Number 212 (Monday, November 3, 1997)]
[Notices]
[Pages 59380-59381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28990]
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NUCLEAR REGULATORY COMMISSION
NRC/Nuclear Pharmacy and Radiopharmaceutical Manufacturer
Industry--Public Workshop on the Public Comments on Draft Regulatory
Guides DG-0006 and DG-0007
AGENCY: U.S. Nuclear Regulatory Commission.
ACTION: Notice of meeting.
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SUMMARY: The U.S. Nuclear Regulatory Commission will be holding a
public meeting to discuss the public comments received on two draft
regulatory guides: Draft Regulatory Guide DG-0006, ``Guide for the
Preparation of Applications for Commercial Nuclear Pharmacy Licenses,''
and Draft Regulatory Guide DG-0007, ``Guide for the Preparation of
Applications for Licenses to Authorize Distribution of Various Items to
Commercial Nuclear Pharmacies and Medical Use Licensees.'' These
documents provide guidance to individuals applying for commercial
nuclear pharmacy and radiopharmaceutical manufacturer distribution
licenses. Representatives of
[[Page 59381]]
these categories of licensees have been invited to discuss the public
comments on the draft guides and the staff's proposed resolutions of
the comments, as well as alternative solutions presented at the
meeting. (Draft Regulatory Guide DG-0007 also includes guidance for
sealed source and device manufacturers, but since this guidance was not
changed, it will not be discussed at this meeting.) The workshop will
be held at NRC Headquarters in Rockville, MD.
DATES: The meeting will begin at 8:30 a.m. and close at 4:30 p.m., on
November 21, 1997.
ADDRESSES: U.S. Nuclear Regulatory Commission, One White Flint North,
11555 Rockville Pike (Auditorium), Rockville, MD 20852-2738.
FOR FURTHER INFORMATION CONTACT: Donna-Beth Howe, Ph.D., U.S. Nuclear
Regulatory Commission, Office of Nuclear Material Safety and
Safeguards, MS T8F5, Washington, DC 20555, telephone (301) 415-7848, e-
mail dbh@nrc.gov.
SUPPLEMENTARY INFORMATION: NRC published three draft regulatory
guides, in March 1997, for public comment. Two of the draft guides
(Draft Regulatory Guide DG-0006, ``Guide for the Preparation of
Applications for Commercial Nuclear Pharmacy Licenses,'' and Draft
Regulatory Guide DG-0007, ``Guide for the Preparation of
Applications for Licenses to Authorize Distribution of Various
Items to Commercial Nuclear Pharmacies and Medical Use Licensees'')
provide guidance to individuals applying for commercial nuclear
pharmacy and radiopharmaceutical manufacturer distribution licenses
issued pursuant to Title 10, U.S. Code of Federal Regulations (10
CFR) part 32, ``Specific Domestic Licenses to Manufacture or
Transfer Certain Items Containing Byproduct Material.'' The third
draft guide (Draft Regulatory Guide DG-0009, ``Proposed Supplement
to Regulatory Guide 10.8, Revision 2, ``Guide for the Preparation
of Applications for Medical Use Programs''') provides guidance for
part 35 medical use licensees. The official comment period for all
three guides closed July 31, 1997.
On November 21, 1997, NRC will be holding a public meeting, at NRC
Headquarters, with invited nuclear pharmacy and radiopharmaceutical
manufacturer industry representatives to discuss the public comments
received on DG-0006 and DG-0007 and staff's proposed resolutions of
these comments, as well as any alternatives presented at the meeting.
In addition, the staff will explore, with the meeting participants, the
extent to which these regulatory guides allow for flexibility in the
licensing process and represent risk-informed and performance-oriented
guidance.
The workshop will not address the third draft guide (DG-0009),
which is for 10 CFR part 35 medical use licensees, and will not include
discussion of the staff's efforts to revise part 35. Separate public
meetings are being held to solicit public input on the revision of 10
CFR part 35 (62 FR 53249).
Larry W. Camper, Chief, Medical, Academic, and Commercial Use
Safety Branch, will chair the workshop. To ensure participation by the
spectrum of interests that may be impacted by the regulatory guides, a
panel of nuclear pharmacy and radiopharmaceutical manufacturer industry
representatives has been invited and will lead the discussion. Other
members of the public are welcome to attend, and the public will have
the opportunity to comment at periodic intervals during the workshop.
To keep the workshop focused on the public comments and the staff's
resolution of those comments, the workshop will have a pre-defined
agenda, but the format will be sufficiently flexible to allow for the
introduction of alternative resolutions to the comments and related
issues that the participants may want to raise. The workshop commentary
will be transcribed and made available to the invited participants and
the public.
Persons who wish to provide a written statement should submit a
reproducible copy to Dr. Howe (address listed previously) by November
15, 1997. Statements must pertain to the specific scope of the
workshop. Persons who wish to obtain copies of the draft regulatory
guides and public comments received may contact the NRC Public Document
Room (PDR) or Dr. Howe.
The transcript and written comments will be available for
inspection, and copying, for a fee, at the NRC PDR, 2120 L Street,
N.W., Lower Level, Washington, DC 20555, or by writing to the U.S.
Nuclear Regulatory Commission, Attention: NRC Public Document Room,
Washington, DC 20555-0001, or by phoning (202) 634-3273, on or about
December 1, 1997.
Dated at Rockville, MD this 28th day of October 1997.
For the Nuclear Regulatory Commission.
Steven L. Baggett,
Acting Chief, Medical, Academic and Commercial Use Safety Branch,
Division of Industrial and Medical Nuclear Safety, Office of Nuclear
Material Safety and Safeguards.
[FR Doc. 97-28990 Filed 10-31-97; 8:45 am]
BILLING CODE 7590-01-P
