[Federal Register Volume 67, Number 75 (Thursday, April 18, 2002)]
[Proposed Rules]
[Pages 19138-19140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9468]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Regulation No. 4]
RIN 0960-AD67


Revised Medical Criteria for Evaluating Hematological Disorders 
and Malignant Neoplastic Diseases

AGENCY: Social Security Administration.

ACTION: Proposed rules; reopening of comment period.

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SUMMARY: We are reopening the comment period for the notice of proposed 
rulemaking (NPRM) we published in the Federal Register (66 FR 59306) on 
November 27, 2001. Due to the significant issues raised by the 
commenters, we have decided to provide an additional 60-day public 
comment period.

DATES: The comment date of the NPRM published at 66 FR 59306 is 
reopened until June 17, 2002.

ADDRESSES: You may give us your comments by using: our Internet site 
facility (i.e., Social Security Online) at http://www.ssa.gov/regulations; e-mail to [email protected]; telefax to (410) 966-2830; 
or by letter to the Commissioner of Social Security, P.O. Box 17703, 
Baltimore, Maryland 21235-

[[Page 19139]]

7703. You may also deliver them to the Office of Process and Innovation 
Management, Social Security Administration, 2109 West Low Rise, 6401 
Security Boulevard, Baltimore, Maryland 21235-6401, between 8 a.m. and 
4:30 p.m. on regular business days. Comments are posted on our Internet 
site, or you may inspect them on regular business days by making 
arrangements with the contact person shown below.
    Electronic Version: The electronic file of this document is 
available on the date of publication in the Federal Register at http://www.access.gpo.gov/su_docs/aces/aces140.html. It is also available on 
the Internet site for SSA (i.e., Social Security Online) at http://www.ssa.gov/regulations/.

FOR FURTHER INFORMATION CONTACT: Suzanne DiMarino, Social Insurance 
Specialist, Office of Process and Innovation Management, Social 
Security Administration, 2109 West Low Rise, 6401 Security Boulevard, 
Baltimore, Maryland 21235-6401, (410) 966-5995 or TTY (410) 966-5609. 
For information on eligibility or filing for benefits, call our 
national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or 
visit our Internet web site, Social Security Online, at www.ssa.gov.

SUPPLEMENTARY INFORMATION: On November 27, 2001, we published ``Revised 
Medical Criteria for Evaluating Hematological Disorders and Malignant 
Neoplastic Diseases'' as an NPRM in the Federal Register (66 FR 59306). 
This NPRM proposed to revise the criteria in the Listing of Impairments 
(the listings) that we use to evaluate claims involving hematological 
disorders and malignant neoplastic diseases. In the NPRM, we provided a 
60-day comment period that ended January 28, 2002. Most of the comments 
on the NPRM were received during the end of the comment period. These 
comments raised significant issues regarding the proposed criteria. In 
order to allow the public sufficient time to review and comment on 
these issues, we are providing an additional 60-day comment period. The 
comments are posted on our Internet site (i.e., Social Security Online) 
at http://www.ssa.gov/regulations. We are also providing a list of the 
medical and other technical sources we consulted when we developed 
these proposed rules.

References

    A list of the sources we consulted when developing the NPRM 
``Revised Medical Criteria for Evaluating Hematological Disorders 
and Malignant Neoplastic Diseases'' (66 FR 59306) include the 
following:
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of Pediatric Oncology. Third Edition, Philadelphia: Lippincott-
Raven, 1997.
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Fourteenth Edition, New York: McGraw Hill, 1998:334-364, 493-747.
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New England Journal of Medicine, 337(26) 25 December 1997:1914-1915.
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History and Prognostic Factors in 657 Consecutive Patients.'' 
Journal of Clinical Oncology, 12(6) June 1994:1272-1280.
    Samy El-Sayed and Norma Nelson. ``Adjuvant and Adjunctive 
Chemotherapy in the Management of Squamous Cell Carcinoma of the 
Head and Neck Region: A Meta-Analysis of Prospective and Randomized 
Trials.'' Journal of Clinical Oncology, 14(3) March 1996:838-847.
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of High-Risk Resected Cutaneous Melanoma: The Eastern Cooperative 
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January 1996:7-17.
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Survival in Primary CNS Lymphoma.'' Journal of Clinical Oncology, 
16(3) March 1998:859-863.
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1 Year After Allogeneic or Autologous Stem-Cell Transplantation: A 
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1999:706-718.
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Special?'' Journal of Clinical Oncology, 16(6) June 1998:2003-2006.
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Classification of Lymphoid Neoplasms: A Proposal From the 
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1994:1361-1392.
    Hannes Wandt, et al. ``Safety and Cost Effectiveness of a 10 
x10\9\/L Trigger for Prophylactic Platelet Transfusions Compared 
With the Traditional 20 x 10\9\/L Trigger: a Prospective Comparative 
Trial in 105 Patients With Acute Myeloid Leukemia.'' Blood, 91(10) 
15 May 1998:3601-3606.
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and Therapy.'' Annals of Internal Medicine, 131(3) 3 August 
1999:207-219.
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``Carcinoma of the Anal Canal.'' The New England Journal of 
Medicine, 342(11) 16 March 2000:792-799.
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Without Flutamide For Metastatic Prostate Cancer.'' The New England 
Journal of Medicine, 339(15) 8 October 1998:1036-1042.
    Scott T. Miller, et al. ``Prediction of Adverse Outcomes in 
Children with Sickle Cell Disease.'' The New England Journal of 
Medicine, 342(2) 13 January 2000:83-89.
    C. P. Karakousis. ``Surgical Treatment of Malignant Melanoma.'' 
Surgical Clinics of North America, 76(6) December 1996:1299-1312.
    Martin H. Steinberg. ``Sickle Cell Disease: Pathophysiology, 
Diagnosis, and Treatment.'' Federal Practitioner, December 1998:22-
47.
    Michael D. Prados, Mitchell S. Berger, and Charles B. Wilson. 
``Primary Central Nervous System Tumors: Advances in Knowledge and 
Treatment.'' CA-A Cancer Journal for Clinicians, 48(6) November/
December 1998:331-360.
    D. H. Kraus, et al. ``Surgical management of squamous cell 
carcinoma of the base of the tongue.'' American Journal of Surgery, 
166(4) October 1993:384-388.
    David M. Brizel, et al. ``Hyperfractionated Irradiation with or 
without Concurrent Chemotherapy for Locally Advanced Head and Neck 
Cancer.'' New England Journal of Medicine, 338(25) 18 June 
1998:1798-1804.
    H. J. Lee, et al. ``Long-term regional control after radiation 
therapy and neck dissection for base of tongue carcinoma.'' 
International Journal of Radiation Oncology, Biology and Physics, 
38(5) 15 July 1997: 995-1000.
    D. P. Derman, et al. ``Adjuvant Chemotherapy (CMF) For Stage III 
Breast Cancer: A Randomized Trial.'' International Journal of 
Radiation Oncology, Biology and Physics, 17(2) August 1989:257-261.
    Karen J. Halverson, et al. ``Survival Following Locoregional 
Recurrence Of Breast Cancer: Univariate And Multivariate Analysis.'' 
International Journal of Radiation Oncology, Biology and Physics, 
23(2) 1992:285-291.
    Benjamin Corn, et al. ``Endometrial Cancer With Para-Aortic 
Adenopathy: Patterns Of Failure And Opportunities For Cure.'' 
International Journal of Radiation Oncology, Biology and Physics, 
24(2) 1992:223-227.
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patients treated with primary radiotherapy for squamous cell cancer 
of the base of the tongue.'' Head & Neck, 19(3) May 1997:169-175.
    G. J. Moore, J. T. Parsons, and W. M. Mendenhall. ``Quality of 
life outcomes after primary radiotherapy for squamous cell carcinoma 
of the base of tongue.''

[[Page 19140]]

International Journal of Radiation Oncology, Biology and Physics, 
36(2) 1 September 1996:351-354.
    M. Machtay, et al. ``Combined surgery and postoperative 
radiotherapy for carcinoma of the base of the tongue: analysis of 
treatment outcome and prognostic value of margin status.'' Head & 
Neck, 19(6) September 1997:494-499.
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and Neck Cancer.'' Oncology, 14(11A) November 2000:163-194.
    William H. Zinkham, Alexander J. Seidler, and Thomas S. Kickler. 
``Variable degrees of suppression of hemoglobin S synthesis in 
subjects with hemoglobin SS disease on a long-term transfusion 
regimen.'' Journal of Pediatrics, 124 February 1994:215-219.
    Clifton F. Mountain. ``Revision in the International System for 
Staging Lung Cancer.'' Chest, 111(6) June 1997:1710-1717.
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Node Classification for Lung Cancer Staging.'' Chest, 111(6) June 
1997:1718-1723.
    James R. Jett. ``What's New in Staging of Lung Cancer?'' Chest, 
111(6) June 1997:1486-1487.
    James E. Krook, et al. ``A Prospective, Randomized Evaluation of 
Intensive-Course 5-Fluorouracil Plus Doxorubicin as Surgical 
Adjuvant Chemotherapy for Resected Gastric Cancer.'' Cancer, 67(10) 
15 May 1991:2454-2458.
    Aman U. Busdar, et al. ``Clinical Course of Patients With Breast 
Cancer With Ten or More Positive Nodes Who Were Treated With 
Doxorubicin-Containing Adjuvant Therapy.'' Cancer, 69(2) 15 January 
1992:448-452.
    William J. Hoskins. ``Surgical Staging and Cytoreductive Surgery 
of Epithelial Ovarian Cancer.'' Cancer Supplement, 71(4) 15 February 
1993:1534-1540.
    Carlos Perez, et al. ``Management of Locally Advanced Carcinoma 
of the Breast.'' Cancer Supplement, 74(1) 1 July 1994:466-476.
    Stephen C. Rubin, et al. ``Prognostic Factors for Recurrence 
following Negative Second-Look Laparotomy in Ovarian Cancer Patients 
Treated with Platinum-Based Chemotherapy \1,2\.'' Gynecologic 
Oncology, 42 3 January 1991:137-141.
    Naoto T. Ueno, et al. ``Combined-modality treatment of 
inflammatory breast carcinoma: twenty years of experience at M.D. 
Anderson Cancer Center.'' Cancer Chemotherapy and Pharmacology, 40 
1997:321-329.
    Michael Moore, et al. ``Inflammatory Breast Cancer.'' Archives 
of Surgery, 126 March 1991:304-306.
    Aman U. Buzdar, et al. ``Ten-Year Results of FAC Adjuvant 
Chemotherapy Trial in Breast Cancer.'' American Journal of Clinical 
Oncology, 12(2) 1989:123-128.
    B. A. Leone, et al. ``Stage IV Breast Cancer: Clinical Course 
and Survival of Patients with Osseous Versus Extraosseous Metastases 
at Initial Diagnosis.'' American Journal of Clinical Oncology, 11(6) 
1988:618-622.
    Michael M. Sherry, et al. ``Metastatic Breast Cancer Confined to 
the Skeletal System.'' American Journal of Medicine, 81 September 
1986:381-386.
    Per-Uno Malmstrom, et al. ``Five-Year Followup Of A Prospective 
Trial Of Radical Cystectomy And Neoadjuvant Chemotherapy: Nordic 
Cystectomy Trial I.'' The Journal of Urology, 55 June 1996:1903-
1906.
    Mario A. Eisenberger, et al. ``Prognostic Factors in Stage 
D2 Prostate Cancer; Important Implications for Future 
Trials: Results of a Cooperative Intergroup Study (INT. 0036).'' 
Seminars in Oncology, 21(5) October 1994:613-619.
    Charles M. Balch, et al. ``A Multifactorial Analysis of 
Melanoma.'' Annals of Surgery, 193(3) March 1981:377-388.
    ``A Genetic Overview of Thalassemia'' available at http://www.thalassemia.com/genetics>.
    ``Psycho-social Aspects'' available at http://www.thalassemia.com/psych>.
    ``Thalassemia'' available at http://sickle.bwh.harvard.edu/thalover.html>.
    ``Medical Management'' available at http://www.thalassemia.com/medical/definition.shtml>.
    ``Frequently Asked Questions'' available at http://www.thalassemia.com/faq>.
    ``Sickle Cell Anemia'' available at http://www.healthanswers.com/database/ami/converted/000527.html>
    ``Sickle Cell Anemia'' available at http://www.emory.edu/PEDS/SICKLE/sicklept.htm>
    ``Anemia'' available at http://www.mayohealth.org/mayo/9511/htm/anemia.htm>

    These references are included in the rulemaking record for these 
proposed rules and are available for inspection by interested persons 
by making arrangements with the contact person shown above.

    Dated: April 4, 2002.
Jo Anne B. Barnhart,
Commissioner of Social Security.
[FR Doc. 02-9468 Filed 4-17-02; 8:45 am]
BILLING CODE 4191-02-P