Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Proposed Rules 22877 

1. Highly malignant tumors, such as 

medulloblastoma or other primitive 

neuroectodermal tumors (PNETs) with 

documented metastases, grades III and IV 

astrocytomas, glioblastoma multiforme, 

ependymoblastoma, diffuse intrinsic brain 

stem gliomas, or primary sarcomas. 

2. Progressive or recurrent following initial 

antineoplastic therapy. 

* * * * * 

13.14 Lungs. 

* * * * * 

OR 

C. Carcinoma of the superior sulcus 

(including Pancoast tumors) with multimodal 

antineoplastic therapy. Consider under a 

disability until at least 18 months from the 

date of diagnosis. Thereafter, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

* * * * * 

13.23 Cancers of the female genital tract—

carcinoma or sarcoma. 

* * * * * 

E. Ovaries, as described in 1 or 2: 

1. All tumors except germ cell tumors, with 

at least one of the following: 

a. Tumor extension beyond the pelvis; for 

example, tumor implants on peritoneal, 

omental, or bowel surfaces. 

b. Metastases to or beyond the regional 

lymph nodes. 

c. Recurrent following initial 

antineoplastic therapy. 

* * * * * 

13.24 Prostate gland—carcinoma. 

* * * * * 

B. With visceral metastases (metastases to 

internal organs). 

* * * * * 

13.27 Primary site unknown after 

appropriate search for primary—metastatic 

carcinoma or sarcoma, except for squamous 

cell carcinoma confined to the neck nodes. 

* * * * * 

Part B 

* * * * * 

113.00 MALIGNANT NEOPLASTIC 

DISEASES 

* * * * * 

I. What do these terms in the listings 

mean? 

1. Metastases: The spread of tumor cells by 

blood, lymph, or other body fluid. This term 

does not include the spread of tumor cells by 

direct extension of the tumor to other tissue 

or organs. 

2. Persistent: Failure to achieve a complete 

remission. 

3. Progressive: The malignancy became 

more extensive after treatment. 

4. Recurrent, relapse: A malignancy that 

had been in complete remission or entirely 

removed by surgery has returned. 

* * * * * 

K. How do we evaluate specific malignant 

neoplastic diseases? 

1. Lymphoma. 

a. We provide criteria for evaluating 

aggressive lymphomas that have not 

responded to antineoplastic therapy in 

113.05. Indolent lymphomas are rare in 

children. We will evaluate indolent 

lymphomas in children under 13.05 in part 

A. 

* * * * * 

2. Leukemia. 

a. Acute leukemia. * * * Recurrent disease 

must be documented by peripheral blood, 

bone marrow, or cerebrospinal fluid 

examination, or by testicular biopsy. * * * 

* * * * * 

4. Thyroid tumors. We use the criteria in 

113.09 to evaluate anaplastic carcinoma and 

carcinoma treated with radioactive iodine. 

Medullary carcinoma of the thyroid gland, 

which is not treated with radioactive iodine, 

is rare in children. We evaluate medullary 

carcinoma in children under 13.09C in part 

A. 

5. Brain tumors. We use the criteria in 

113.13 to evaluate malignant brain tumors. 

We consider a brain tumor to be malignant 

if it is classified as grade II or higher under 

the World Health Organization’s 

classification of tumors of the central nervous 

system (WHO Classification of Tumours of 

the Central Nervous System, 2007). We 

evaluate any complications of malignant 

brain tumors, such as resultant neurological 

or psychological impairments, under the 

criteria for the affected body system. We 

evaluate benign brain tumors under 111.05. 

* * * * * 

113.01 Category of Impairments, Malignant 

Neoplastic Diseases 

* * * * * 

113.13 Brain tumors. (See 113.00K5.) 

Highly malignant tumors, such as 

medulloblastoma or other primitive 

neuroectodermal tumors (PNETs) with 

documented metastases, grades III and IV 

astrocytomas, glioblastoma multiforme, 

ependymoblastoma, diffuse intrinsic brain 

stem gliomas, or primary sarcomas. 

* * * * * 

[FR Doc. E8–9170 Filed 4–25–08; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 872 

[Docket No. FDA–2008–N–0163] (formerly 

Docket No. 2001N–0067) 

Dental Devices: Classification of 

Encapsulated Amalgam Alloy and 

Dental Mercury and Reclassification of 

Dental Mercury; Issuance of Special 

Controls for Amalgam Alloy; 

Reopening of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; reopening of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening for 

90 days, the comment period for the 

proposed rule, published in the Federal 

Register of February 20, 2002 (67 FR 

7620), on the classification of 

encapsulated amalgam alloy and dental 

mercury, the reclassification of dental 

mercury, and the issuance of special 

controls for amalgam alloy. In the 

Federal Register of July 17, 2002 (67 FR 

46941), the initial comment period was 

reopened for 60 days. The agency is 

taking this action to provide the public 

with an additional opportunity to 

comment and to request data and 

information that may have become 

available since publication of the 

proposed rule. 

DATES: Submit written or electronic 

comments by July 28, 2008. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2008–N–

0163 (formerly Docket No. 2001N–

0067), by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘How to Submit 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 


rwilkins on PROD1PC63 with PROPOSALS
22878 Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Proposed Rules 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael E. Adjodha, Center for Devices 

and Radiological Health (HFZ–480), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3688. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 

20, 2002 (67 FR 7620), FDA published 

a proposed rule entitled ‘‘Dental 

Devices: Classification of Encapsulated 

Amalgam Alloy and Dental Mercury and 

Reclassification of Dental Mercury; 

Issuance of Special Controls for 

Amalgam Alloy.’’ In that document, 

FDA proposed the following actions: (1) 

Issue a separate classification regulation 

for encapsulated amalgam alloy and 

dental mercury; (2) amend the 

classification for amalgam alloy by 

adding special controls; and (3) 

reclassify dental mercury from class I 

(general controls) to class II. FDA 

proposed that all three products would 

have the same labeling guidance as a 

special control. In addition, FDA 

proposed that dental mercury would 

have a voluntary American National 

Standards Institute (ANSI) standard as a 

special control; encapsulated amalgam 

alloy and dental mercury would have 

voluntary ANSI and International 

Standards Organization (ISO) standards 

as special controls; and the amalgam 

alloy products would have a voluntary 

ISO standard as a special control. Since 

that time, a 2006 joint meeting of the 

Dental Products Panel and the 

Peripheral and Central Nervous System 

Drugs Advisory Committee raised the 

need for FDA to further consider 

scientific issues that are potentially 

relevant to this classification and we 

seek additional comments on the 

proposed classification. 

In an effort to provide an update on 

the latest scientific information 

concerning dental amalgam, a working 

group of the U.S. Department of Health 

and Human Services, known as the 

Trans-agency Working Group on the 

Health Effects of Dental Amalgam, 

commissioned a new review of the 

scientific literature in 2004 (the 2004 

review). The 2004 review, funded by the 

National Institutes of Health in 

cooperation with FDA, the Centers for 

Disease Control and Prevention, and the 

Office of the Chief Dental Officer of the 

Public Health Service, was completed in 

2004 by Life Sciences Research Office, 

Inc. (LSRO). LSRO engaged an 

independent panel of experts from 

academia with preeminent 

qualifications and experience in the 

appropriate scientific disciplines 

needed for the 2004 review. The 2004 

review was a systematic and 

comprehensive evaluation of 

approximately 300 peer-reviewed 

studies of dental amalgam and mercury 

vapor published from 1996 through 

2003, intended to determine whether 

these studies provided new evidence 

related to the health effects of dental 

amalgam in humans. The panel 

concluded that the studies contained 

insufficient evidence to support a 

correlation or causal relationship 

between exposure to dental amalgam 

and kidney or cognitive dysfunction; 

neurodegenerative disease (specifically 

Alzheimer’s disease and Parkinson’s 

disease); autoimmune disease 

(including multiple sclerosis); or 

adverse pregnancy outcomes (Refs. 1 

and 2). 

Dental amalgam was the subject of an 

advisory committee meeting in 2006. As 

announced in the Federal Register of 

April 3, 2006 (71 FR 16582), on 

September 6 and 7, 2006, FDA held a 

joint meeting of the Dental Products 

Panel and the Peripheral and Central 

Nervous System Drugs Advisory 

Committee (the 2006 joint committee). 

The 2006 joint meeting was held to 

discuss and make recommendations to 

FDA on a draft FDA White Paper (2006 

draft White Paper) (Ref. 3) regarding the 

potential adverse health risks associated 

with exposure to mercury in dental 

amalgam. The goal of the 2006 draft 

White Paper was to provide an 

assessment and conclusions regarding 

significant new information and health 

risks from mercury in dental amalgam 

and to build on previous Public Health 

Service literature reviews and risk 

assessments (1993 and 1997) and 

reviews by other Federal agencies since 

1997. The 2006 joint committee, 

comprised of 24 panelists, heard 

presentations from the following groups: 

(1) Scientists; (2) regulatory officials 

from Canada and Sweden, on the 

scientific basis for the regulation of 

dental amalgam in their respective 

countries; and (3) FDA, on how the 

United States has regulated and 

evaluated dental amalgam. Numerous 

public speakers also presented their 

views. 

The 2006 joint committee then 

deliberated on a series of questions FDA 

had posed on its draft review of the 

dental amalgam literature and provided 

recommendations to the agency related 

to those questions (Ref. 4). By majority 

vote, the committee concluded that 

FDA’s draft White Paper had significant 

limitations. Among its criticisms, the 

2006 joint committee identified 

insufficient explanation about the 

following: (1) How the scientific 

references were chosen; (2) failure to 

identify the significant gaps in the 

scientific knowledge, particularly with 

respect to exposure limits; and (3) lack 

of attention to sensitive subpopulations. 

The majority of the 2006 joint 

committee voted that it could not find 

the conclusions of the draft White Paper 

to be ‘‘reasonable.’’

Despite the limitation on the draft 

White Paper, the 2006 joint committee 

generally agreed that there is no 

evidence that dental amalgams cause 

health problems. The 2006 joint 

committee also agreed that the most 

recent well-controlled clinical studies, 

including two prospective clinical 

studies in children (Refs. 5 and 6), 

showed no evidence of neurological 

harm from dental amalgams. In 

addition, a more recent article 

corroborated this evidence (Ref. 7). 

Panelists provided individual 

recommendations, including 

recommendations that FDA consider 

requirements related to the use of dental 

amalgam in pregnant women and small 

children, as well as patient information 

to ensure that consumers understand 

that these devices contain mercury. 

II. Reopening of the Comment Period 

FDA believes it is important for 

members of the public to have the 

opportunity to further comment on 

FDA’s proposal. Accordingly, FDA is 

asking for comments concerning 

whether these devices should be 

classified into class II (special controls). 

We specifically request comments 

supported by empirical data and 

scientific evidence concerning this 

classification and these special controls. 

In addition, if class II (special controls) 

is the appropriate classification for these 

devices, FDA requests comment on 

whether the two types of special 

controls proposed by FDA in 2002 

(materials and labeling) provide 

reasonable assurance of the safety and 

effectiveness of these devices and on 

whether the proposed special control 

guidance document should be revised in 

light of the recommendations and with 

respect to the discussions by the 2006 

joint committee. 

• Controls on the Materials. For 

example, should the material controls 

proposed by FDA address conformance 

to recognized consensus standards that 

make recommendations for testing, 

compressive strength, and identifying 

the mercury vapor released by the 

device? 

• Labeling Controls. For example, 

how should labeling controls, if any, 


rwilkins on PROD1PC63 with PROPOSALS
Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Proposed Rules 22879 

address the disclosure of composition, 

including mercury content, and 

precautions regarding use of the device 

in sensitive subpopulations composed 

of individuals who respond biologically 

at lower levels of exposure to mercury 

than the general population? If so, 

which subpopulations should be 

included (e.g., children under age 6, 

pregnant and lactating women, 

hypersensitive or immunocompromised 

individuals)? Should the labeling 

controls require more specific patient 

labeling (e.g., informing patients of 

identified sensitive subpopulations of 

the mercury content, the alternatives to 

the device and their relative costs, and 

health risks associated with the failure 

to obtain dental care)? 

For the agency’s future analysis of 

benefits and costs of the regulatory 

options for dental amalgams, FDA also 

requests comments, including available 

data, on the following questions: 

(1) How many annual procedures use 

mercury amalgams? What are the 

trends? 

(2) What are the differences in cost 

between amalgams and alternative 

materials (e.g., composite, other metals, 

ceramics, etc.)? Are there differences in 

replacement lives? 

(3) What are reimbursement rates for 

dental amalgam and the alternative 

materials? 

(4) How would labeling describing the 

risks of amalgam for certain 

subpopulations (e.g., children under age 

6, pregnant and lactating women, 

hypersensitive or immunocompromised 

individuals) affect the demand for, and 

use of, mercury amalgam? How would 

the risks included in the labeling be 

communicated to those subpopulations? 

(5) What is the current exposure to 

mercury for patients? For professionals? 

What would be the reduction in 

exposure associated with the 

alternatives described previously in this 

section of this document? 

III. How to Submit Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments to http://www.regulations.gov 

or two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Governmental-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

IV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Review and Analysis of the Literature on 

the Potential Adverse Health Effects of Dental 

Amalgam, LSRO, July 2004. 

2. Brownawell, A.M., et al., ‘‘The Potential 

Adverse Health Effects of Dental Amalgam,’’

Toxicological Reviews, 24(1):1–10, 2006. 

3. Draft FDA Update/Review of Potential 

Adverse Health Risks Associated With 

Exposure to Mercury in Dental Amalgam, 

National Center for Toxicological Research, 

FDA, August 2006. 

4. Transcripts from the Joint Meeting of 

Dental Products Panel and Central Nervous 

System Drugs Advisory Committee, 

September 6 and 7, 2006. 

5. Bellinger, D.C., et al., 

‘‘Neuropsychological and Renal Effects of 

Dental Amalgam in Children: A Randomized 

Trial,’’ Journal of the American Medical 

Association, 295:1775–1783, 2006. 

6. DeRouen, T.A., et al., ‘‘Neurobehavioral 

Effects of Dental Amalgam in Children: A 

Randomized Clinical Trial,’’ Journal of the 

American Medical Association, 295:1784–

1792, 2006. 

7. Dunn, Julie E., ‘‘Scalp hair and urine 

mercury content of children in the Northeast 

United States: The New England Children’s 

Amalgam Trial,’’ Environmental Research, 

Vol. 107, Issue 1, pages 79 to 88, May 2008. 

Dated: April 22, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. 08–1187 Filed 4–23–08; 10:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 301 

[REG–208199–91] 

RIN 1545–BC55 

Suspension of Running of Period of 

Limitations During a Proceeding to 

Enforce or Quash a Designated or 

Related Summons 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

and withdrawal of notice of proposed 

rulemaking. 

SUMMARY: This document contains 

proposed regulations regarding the use 

of designated summonses and related 

summonses and the effect on the period 

of limitations on assessment when a 

case is brought with respect to a 

designated or related summons. This 

document also withdraws the previous 

proposed regulations published in the 

Federal Register on July 31, 2003 (68 FR 

44905). These proposed regulations 

reflect changes to section 6503 of the 

Internal Revenue Code of 1986 made by 

the Omnibus Budget Reconciliation Act 

of 1990 and the Small Business Job 

Protection Act of 1996. These 

regulations affect corporate taxpayers 

that are examined under the 

coordinated issue case (CIC) program 

and are served with designated or 

related summonses. These regulations 

also affect third parties that are served 

with designated or related summonses 

for information pertaining to the 

corporate examination. 

DATES: Written or electronic comments 

and requests for a public hearing must 

be received by July 28, 2008. 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–208199–91), room 

5203, Internal Revenue Service, P.O. 

Box 7604, Ben Franklin Station, 

Washington, DC 20044. Alternatively, 

submissions may be hand delivered 

between the hours of 8 a.m. and 4 p.m. 

to: CC:PA:LPD:PR (REG–208199–91), 

Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC. Comments may 

also be submitted electronically to the 

Federal eRulemaking Portal at http:// 

www.regulations.gov (IRS REG–208199–

91). 

FOR FURTHER INFORMATION CONTACT: 

Concerning the proposed regulations, 

Elizabeth Rawlins, (202) 622–3630; 

concerning submissions of comments, 

Richard Hurst, (202) 622–7180 or 

Richard.A.Hurst@IRSCounsel.Treas.Gov 

(not toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

This document contains proposed 

regulations amending the Procedure and 

Administration regulations (26 CFR part 

301) under section 6503. Section 11311 

of the Omnibus Budget Reconciliation 

Act of 1990 (Pub. L. 101–508, 104 Stat. 

1388) amended section 6503(k) to 

suspend the period of limitations on 

assessment when a case is brought with 

respect to a designated or related 

summons. Section 6503(k) was 


rwilkins on PROD1PC63 with PROPOSALS