ML20195G241

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Responds to Expressing Concerns Re Proposed Changes in NRC 10CFR35 Regulations on Medical Use of Byproduct Matls
ML20195G241
Person / Time
Issue date: 11/10/1998
From: Shirley Ann Jackson, The Chairman
NRC COMMISSION (OCM)
To: Archer B, Armey R, J. J. Barton, Bentsen K, Bonilla H, Brady K, Delay T, Green G, Johnson S, Lampson N, Samson Lee, Paul R, Sandlin M, Sessions P, Stenholm C
HOUSE OF REP.
Shared Package
ML20195G247 List:
References
NUDOCS 9811200236
Download: ML20195G241 (15)


Text

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. %t f b UNITED STATES 0 k

1 p NUCLEAR REGULATORY COMMISSION 0 WASHINGTON, D.C. 200SH001 b b .67 Khuf g* November 10, 1998 cww.m .

The Honorable Henry Bonilla United States House of Representatives Washington, D.C. 20515 -

Dear Congressman Bonilla:

l l am responding to your letter, dated September.18,1998, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concemed that the proposed changes in the number of hours of training and experience required for using l radioactive materials (1 131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

l The Commission considers the overallissue of training and experience to be one of the most i

impc tant issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive materialin medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered ,

! the public input, including comments from the American Association of Clinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 4 l 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August.13,1998, the proposed rulemaking was published in the Federal Register, for a l 90-day public comment period. A series of public meetings was also scheduled during the l comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in

Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings l were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the l Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at these meetings.

The Commission plans to carefully evaluate all the public comments in finalizing the training l and experience requirements for users of byproduct material. If you need additional l information, please do not hesitate to let me know.

l.

l Sincerely, e 4 10 ,

i k g) g Shirley Ann Jackson 9811200236 981110 PDR COMMS MtCC

, CORRESPONDENCE PDR l

,#  % UNITED STATES

. p *g NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 2"o66dHM1

\ ..... p November 10, 1998 CHARMAN The' Honorable Gene Green United States House of Representatives Washington, D.C. 20515 De r Congressman Green:  ;

I I am responding to your letter, dated September 18,1998, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concemed that the proposed changes in the number of hours of training and experience required for using ,

radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary l burden for physicians, particularly endocrinologists.

The Commission considers the overallissue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive materialin medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered the public input, including comments from the Ameican Association of Clinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal Realster. for a 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19 20,1998, in San Francisco, California and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at these meetings.

The Commission plans to carefully evaluate ei! the public comments in finalizing the training and experience requirements for users of byproduct material. If you need additional information, please do not hesitate to let me know.

Sincerely,

& f Shirley Ann Jackson

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[ Nr 'g UNITED STATES NUCLEAR REGULATORY COMMISSION 1

WASHINGTON, D.C. 20H6-0001 0

\.....[E CHAMMAN November 10, 1998 I

1 l

The Honorable Pete Sessions l United States House of Representatives Washington, D.C. 20515

Dear Congressman Sessions:

I am responding to your letter, dated September 18,1998, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concerned that the proposed changes in the number of hours of training and experience required for using radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

The Commission considers the overallissue of training and expenence to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive material in medicine. The Commission has, therefore, proposed that the training and experience criteria for all users c' radioactive material be risk-inforraed and focused on safety. Throughout the development of the proposed revisions, the staff considered the public input, including comments from the American Association of Clinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal Reaister. for a 90-day public comment period. A serfec of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Realster on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at those meetings.

The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material, if you need additional information, please do not hesitate to let me know.

Sincerely, b b Shirley Ann Jackson

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[ 'g UNITED STATES NUCLEAR REGULATORY COMMISSION g WASHINGTON, D.C. 2068H001 g

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CHAMMAN November 10, 1998 The Honorable Kevin Brady United States House of Representatives Washington, D.C. 20515

Dear Congressman Brady:

I am responding to your letter, dated September 18,1998, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 l regulations on medical use of byproduct material, in particular, you were concemed that the proposed changes in the number of hours of training and experience required for using l radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary l burden for physicians, particularly endocrinologists.

l The Commissiori considers the overallissue of training and experience to be one of the most j important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive materialin medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered

the public input, including comments from the American Association of Olinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1998. At that time, the Commission directed the staff to study the issue further and provide a l basis for its proposed position.

l On August 13,1998, the proposed rulemaking was published in the Federal Reaister, for a 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at these meetings.

The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material, if you need additional information, please do not hesitate to let me know.

Sincerely, Shirley Ann Jackson i

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, p NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20666-0001 1

% ,g #[ November 10, 1998 CmMAN l The Honorable Sheila Jackson Lee Unlted States House of Representatives Washington, D.C. 20515 -

Dear Congressman Lee:

I am responding to your letter, dated September 18,1998, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concemed that the proposed changes in the number of hours of training and experience required for using radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

The Commission considers the overallissue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the l safe use of radioactive material in medicine. The Commission has, therefore, proposed that the i

training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Thrcughout the development of the proposed revisions, the staff considered j the public input, including comments from the American Association of Clinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal Reaister. for a l 90-day public comment period. A series of public meetings was also scheduled during the l comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in i Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at these meetings.

l The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material. If you need additional l information, please do not hesitate to let me know.

Sincerely, h~~'

Shirley Ann Jackson

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[ *a UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2066H001 e

\qu,/ November 10, 1998 CHAIRMAN The Honorable Max Sandlin United States House of Representatives Washington, D.C. 20515

Dear Congressman Sandlin:

I am responding to your letter, dated September 18,1998, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 .

regulations on medical use of byproduct material. In particular, you were concemed that the proposed changes in the number of hours of training and experience required for using ,

radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary )

burden for physicians, particularly endocrinologists.

The Commission considers the overallissue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the l safe use of radioactive material in medicine. The Commission has, therefore, proposed that the i training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered l

the public input, including comments from the American Association of Clinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal Reaister. for a 90-day public comment period. A series of public meetings was also scheduled during the i comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at these meetings.

The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material. if you need additional information, please do not hesitate to let me know.

Sincerely, Shirley Ann Jackson

._.___-.._m _ _ _ . _ _ . _ . _ _ _ _ _ _ . - . _ _ _ . _ _ _ _ _ . - _ _ _ _ .._.___-

4 UNITED STATES

. \ NUCLEAR REGULATORY COMMISSION I WASHINGTON, D.C. 20086-0001 g g November 10, 1998 k.....

CHAMMAN The Honorable Joe Barton United States House of Representatives Washington, D.C. 20515 -

Dear Congressman Barton:

I am responding to your letter, dated September 18,1998, that expressed concems about prc-;-:::1 changes in the U.S. Nuclear Regulatcry Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concerned that the

proposed changes in the number of hours of training and experience required for using radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

The Commission considers the overallissue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive materialin medicine. The Commission has, therefore, proposed that the j training and experience criteria for all users of radioactive material be risk-informed and j focused on safety. Throughout the development of the proposed revisions, the staff considered i the public input, including comments from the American Association of Clinical Endocrinologists  !

(AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal Register, for a 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in i Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at these meetings.

The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material, if you need additional information, please do not hesitate to let me know.

Sincerely, Shirley Ann Jackson

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UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20565-0001 November 10, 1998

          • p l

l CHAIRMAN ,

L The Honorable Charles Stenholm j United States House of Representatives Washington, D.C. 20515 Debr Congressman Stenholm:

l 1 am responding to your letter, dated September 18,1998, that expressed concerns about i proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 l

regulations on medical use of byproduct material. In particular, you were concemed that the proposed changes in the number of hours of training and experience required for using radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

The Commission considers the overallissue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive material in medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered the public input, including comments from the American Association of Clinical Endocrinologists

! (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June l 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemakirg was published in the Federal Reaister. for a 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, ,

l Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in l Rockville, Maryland on October 21 22,1998. Details of the scheduling of the public meetings were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the t Federal Register notice for these meetings, the Commission, through the facilitator for the l

meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure

! that the endocrinologists' interests are represented at these meetings.

The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material if you need additional information, please do not hesitate to let me know.

Sincerely,

% f '

Shirley Ann Jackson L _

UNITED STATES p r.e:Nr\g NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20886-0001

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November 10, 1998

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cHANIMAN .

l l-The Honorable Richard Armey United States House of Representatives ,

Washington, D.C. 20515 1

Dear Congressman Armey:

I am responding to your letter, dated September 18,1998, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concemed that the proposed changes in the number of hours of training and experience required for using radioactive materials (I-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

l The Commission considers the overall issue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive material in medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and

focused on safety. Throughout the development of the proposed revisions, the staff considered the public input, including comments from the American Association of Clinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal Register, for a 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in l Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure l that the endocrinologists' interests are represented at these meetings.

The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material, if you need additional information, please do not hesitate to let me know.

Sincerely, Shirley Ann Jackson i ,_ __ .._ _ - _ _ . - _ - . _ _ _ _ . _ . _ _ _ _ _ _ _ _ - - .

UNITED STATES p \ g NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20066-0001 November 10, 1998 CHAMMAN .

The Honorable Sam Johnson United States House of Representatives Washington, D.C. 20515 2

Dear Congressman Johnson:

I am responding to your letter, dated September 18,1998, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material in particular, you were concemed that the proposed changes in the number of hours of training and experience re. quired for using radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

The Commission considers the overall issue of training and experience to be one of the most l important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive material in medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered the public input, including comments from the American Association of Clinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June i 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal Register, for a i 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Register on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests w% may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at these meetings.

l The Commission plans to carefully evaluate all the public comments in finalizing the training l and experience requirements for users of byproduct material. If you need additional information, please do not hesitate to let me know.

Sincerely,

^

Shirley Ann Jackson l

l

/ UNITED STATES p k ,

NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20615 0001 e

\,,,,,/ November 10, 1998 CHAIRMAN The Honorable Tom Delay United States House of Representatives Washington, D.C. 20515

Dear Congressman Delay:

I am responding to your letter, dated September 18,1998, that expressed concems about l proposed changes in the U.S. Nuclear Regulatory Cramission's (NRC) 10 CFR Part 35 l regulations on medical use of byproduct material. In particular, you were concemed that the  ;

proposed changes in the number of hours of training and experience required for using radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

The Commission considsrs the overallissue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive material in medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered the public input, including comments from the American Association of Clinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal Reaister. for a 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998,in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Reaister on July 24,1993 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the

meetings, invited participants that represent a broad spectrem of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at these meetings.

l The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material. If you need additional information, please do not hesitate to let me know.

Sincerely, j' g C ,_ b g

/

Shirley Ann Jackson

_._ .m.. . , _ - - . . _. _ .... _ _ . _ _ _ _ _ _ _ _ _ _ _ _ ~ . _ _ ._ _ _ _ ..

1 UNITED STATES

- 1 NUCLEAR REGULATORY COMMISSION

.g WASHINGTON, D.C. 2005H001

  • e

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CHAMMAN November 10, 1998 l

j The Honorable Nick Lampson United States House of Representatives Washington, D.C. 20515

Dear Congressman Lampson:

I am responding to your letter, dated September 18,1998, that expressed concerns about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concemed that the proposed changes in the number of hours of training and experience required for using radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

The Commission considers the overallissue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive materialin medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered the public input, including comments from the American Association of Clinical Endocrinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June  :

1998. At that time, the Commission directed the staff to study the issue further and provide a I bcsis for its proposed poeition.

On August 13,1998, the proposed rulemaking was published in the Federal Register, for a 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in Rockville, Maryland on October 21-22,19G8. Details of the scheduling of the public meetings were published in the Federal Register on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meethgs, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocrinologists' interests are represented at these meetings.

The Commission plans to carefully eva!uate all the public comments in finalizing the training and experience requirements for users of byproduct material. If you need additional information, please do not hesitate to let me know.

Sincerely, M

Shirley Ann Jackson

l /#N UNITED STATES p *g NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 20666-0001 l 0

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CHARMAN November 10, 1998 The Honorable Ron Paul United States House of Represen .tives Washington, D.C. 20515 s

Dear Congressman Paul:

I am responding to your letter, dated September 18,195,3, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concemed that the proposed changes in the number of hours of training and experience required for using  :

radioactive materials (I-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

The Commission considers the overallissue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive material in medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-infonned and focused on safety. Throughout the development of the proposed revisions, the staff considered the public input, including comments from the American Association of Clinical Endocrino!ogists l (AACE). The issue of training for s' Jocrinologists that use byproduct material to treat  ;

hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal ReaistgI. for a 90-day public comment period. A series of public meetings was also scheduled during the I comment period. The first two m 3etings took place August 10-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in

! Rockville, Maryland en October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Regist.gr on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be l affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure j that the endocrinologists' interests are represented at these meetings.

f The Commission plans to ca"efully evaluate all the public comments in finalizing the training i

and experience requirernents for users of byproduct material. If you need additional l information, please do not hesitate to let me know, t

Sincerely, b

} Shirley Ann Jackson

UNITED STATES p

f h*; NUCLEAR REGULATORY COMMISSION

November 10, 1998'

/

CHAIRMAN i The Honorable Bill Archer United States House of Representatives

Washingtm, D.C. 20515

Dear Con Jressman Archer:

I am restonding to your letter, dated September 18,1998, that expressed concems about proposel changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulatLns on medical use of byproduct material. In particular, you were concemed that the proposed changes in the number of hours of training and experience required for using radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

4 The Commission considers the overall issue of training and experience to be one of the most

! important issues addressed during the rulemaking. Adequately trained personnel are key to the j safe use of radioactive material in medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered the public input, including comments from the American Association of Clinical Endocrinologista (AACE). The issue of training for endocrinologists that use byproduct material to treat i

hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position. j On August 13,1998, the proposed rulemaking was published in the Federal Reaister. for a 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, 1 Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in i Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings j l

were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the l i

Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure j that the endocrinologists' interests are represented at these meetings. l The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material. If you need additional information, please do not hesitate to let me know. j Sincerely, b C Shiricy Ann Jackson

1 a

j6 UNITED STATES p be\ NUCLEAR REGULATORY COMM'SSION

. WASHINGTON. D.C. 20886-0001 November 10, 1998 CHAMMAN The Honorable Ken Bentsen United States House of Representatives Washington, D.C. 20515 E

Dear Congressman Bentsen:

I am respondmg to your letter, dated September 18,1998, that expressed concems about proposed changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 t regulations on inedical use of byproduct material. In particular, you were concemed that the proposed changes in the numbar of hours of training and experience required for using .

radioactive materials (1-131) for the treatment of thyroid disease would create an unnecessary burden for physicians, particularly endocrinologists.

The Commission considers the overall issue of training and experience to be one of the most important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive material in medicine. The Commission has, therefore, proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. Throughout the development of the proposed revisions, the staff considered

~ the public input, including comments from the American Association of Clinical Endociinologists (AACE). The issue of training for endocrinologists that use byproduct material to treat hyperthyroidism and thyroid cancer was discussed in a Commission public meeting in June

' 1998. At that time, the Commission directed the staff to study the issue further and provide a basis for its proposed position.

On August 13,1998, the proposed rulemaking was published in the Federal BegigigI, for a 90-day public comment period. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, Califomia and September 16-17,1998, in Kansas City, Missouri. The last meeting was held in Rockville, Maryland on October 21-22,1998. Details of the scheduling of the public meetings were published in the Federal Reaister on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants that represent a broad spectrum of interests which may be affected by the proposed rulemaking. The AACE staff has worked with the NRC staff to ensure that the endocnnologists' interests are represented at these meetings.

The Commission plans to carefully evaluate all the public comments in finalizing the training and experience requirements for users of byproduct material. If you need additional information, please do not hesitate to let me know.

Sincerely,

//W%Q, i

7 /

Shirley Ann Jackson

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