57326 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 

NCD process and other issues involved 

in making coverage determinations. 

Those documents will be specifically 

labeled as guidance documents and do 

not include other CMS reports, 

documents, letters, or program 

instructions. 

Guidance documents give the public, 

particularly individuals or organizations 

that might request an NCD, detailed 

information on current interpretations 

of the statute, the NCD process, and 

related evaluation and decision-making 

factors. A more precise understanding of 

these factors assists product developers 

and others in making decisions by 

understanding:

• The implications of making an NCD 

request. 

• What content is necessary in an 

NCD request. 

• Relevant timelines and their 

relation to the overall NCD process. 

• What types of scientific and other 

information are considered in the 

process. 

• How various types of evidence are 

evaluated for reasonable and necessary 

determinations. 

In general, guidance documents 

reduce uncertainty about key aspects of 

the NCD process. Guidances may be 

useful in certain cases to help plan 

investment strategies, research and 

development efforts, and marketing and 

clinical diffusion strategies. 

CMS strives to achieve consistent and 

fair review of NCDs. Guidances are an 

additional tool that may be used in this 

effort. 

III. Effect of Guidance Documents 

A guidance document represents the 

agency’s current thinking on the 

relevant subject. It is not intended to be 

a comprehensive description or analysis 

of all issues and factors that might affect 

an individual NCD. A guidance 

document is not binding on the Agency 

or the public. For example, the guidance 

documents will describe how we will 

evaluate different types of study designs 

in determining whether an item or 

service is reasonable and necessary. 

This does not mean the absence of a 

particular type of research will 

necessarily result in a noncoverage 

decision nor does submitting data from 

a particular type of study ensure 

coverage. Every effort will be made to 

describe in general terms the factors that 

are most important in making a coverage 

determination. Nonetheless, each NCD 

involves unique factors that cannot be 

described explicitly in the guidance 

documents. 

IV. Development of Guidance 

Documents 

For all guidance documents, the 

public will have an opportunity to 

comment upon issuance. Usually, 

guidance documents will not be 

considered in effect until CMS has 

analyzed public input received during a 

period for public comment. In cases of 

immediate need or for minor policy 

changes, however, guidance documents 

may be made effective upon issuance, 

prior to the public comment period. 

Each document will clearly denote the 

appropriate addresses for hard copy and 

electronic submission of comments. We 

will consider changes to the documents 

based on the comments as appropriate. 

Comments will be taken and reviewed 

on a continuous basis. 

V. Public Notification of New Guidance 

Documents 

We will provide notice of new 

guidance documents and make them 

available on the Internet at http://

www.cms.hhs.gov/coverage. At regular 

intervals, we will update a list of all 

guidance documents in the Federal 

Register. Individuals who need 

assistance accessing the guidance 

documents for any reason may send an 

e-mail to CAGInquiries@cms.hhs.gov. 

VI. Public Input 

We will provide a list of possible 

topics for guidance documents 

development related to section 731 of 

the MMA on our Web site. We invite 

public input regarding these and other 

possible topics for new guidance 

documents via the public comments 

function available at http://

www.cms.hhs.gov/coverage. While these 

suggestions will be given serious 

consideration, we are not required to 

issue every document on the list and are 

not precluded from issuing other 

guidance documents not included on 

the list. 

We will review existing guidance 

documents on a regular basis. The 

public may submit proposals for review 

and revision of existing documents on 

the basis that they are no longer current. 

A statement explaining why the existing 

document needs updating and/or 

revision must accompany each request. 

We will review the statement and, when 

appropriate, develop the necessary 

revisions in accordance with the 

procedures specified in this notice. 

VII. Dissemination/Availability to the 

Public 

A list of all guidance documents will 

be maintained on the CMS Coverage 

home page. The list will include the 

title of each document and issue and 

revision date. 

VIII. List of Proposed Guidance 

Documents 

We will update this list as we 

continue to develop guidance 

documents. The first guidance 

document will be the ‘‘Revised Process 

for Making Medicare National Coverage 

Determinations.’’

Authority: Section 731 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003.

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: May 4, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 04–21197 Filed 9–23–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

Office of AIDS Research Advisory 

Council. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact person listed below 

in advance of the meeting.

Name of Committee: Office of AIDS 

Research Advisory Council. 

Date: October 13–14, 2004. 

Time: 9 a.m. to 12 p.m. 

Agenda: A Report of the Director 

addressing OAR initiatives. The meeting will 

focus on research approaches to addressing 

HIV/AIDS as a chronic disease in the United 

States, including discussions about clinical 

complications, treatment and adherence 

issues, and disease management. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Room 6C10, 

Bethesda, MD 20892. 

Contact Person: Jack Whitescarver, 

Director, Office of AIDS Research, OD, 

National Institutes of Health, 9000 Rockville 

Pike, Building 2, Room 4E14, Bethesda, MD 

20892, (301) 496–0357. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 57327

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

into the building by non-government 

employees. Persons without a government 

I.D. will need to show a photo I.D. and sign 

in at the security desk upon entering the 

building. 

Information is also available on the 

Institute’s/Center’s home page: http://

www.nih.gov/od/oar/index.htm, where an 

agenda and any additional information for 

the meeting will be posted when available.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS)

Dated: September 17, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–21447 Filed 9–23–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Cancer 

Institute Initial Review Group, Subcommittee 

G–Education, Review of K01, K05, K07, K22, 

K23 and K24 Applications. 

Date: October 26–27, 2004. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Suites Alexandria, 601 

North Saint Asaph Street, Alexandria, VA 

22314. 

Contact Person: Ilda M. McKenna, 

Scientific Review Administrator, Research 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Boulevard, Room 

8111, Bethesda, MD 20892, (301) 496–7481, 

mckennai@mail.nih.gov.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS)

Dated: September 16, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–21439 Filed 9–23–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center For Complementary & 

Alternative Medicine; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel; Db–16 Basic 

Science. 

Date: October 18–19, 2004. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: Dale L. Birkle, PhD, 

Scientific Review Administrator, NIH/

NCCAM, 6707 Democracy Blvd., Democracy 

Two Building, Suite 401, Bethesda, MD 

20892, (301) 451–6570, birkled@mail.nih.gov.

Name of Committee: National Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel; JH–05 Clinical 

Science. 

Date: October 25–26, 2004. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Jeanette M. Hosseini, 

Scientific Review Administrator, National 

Center for Complementary and Alternative 

Medicine, 6707 Democracy Blvd., Suite 401, 

Bethesda, MD 20892, (301) 594–9096.

Name of Committee: National Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel. 

Date: November 3–5, 2004. 

Time: 6 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Premier at Tyson’s Corner, 

8661 Leesburg Pike, Vienna, VA 22182. 

Contact Person: Dale L. Birkle, PhD, 

Scientific Review Administrator, NIH/

NCCAM, 6707 Democracy Blvd., Democracy 

Two Building, Suite 401, Bethesda, MD 

20892, (301) 451–6570, birkled@mail.nih.gov.

Name of Committee: National Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel; CP–18 Training. 

Date: November 5, 2004. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Carol Pontzer, PhD, 

Scientific Review Administrator, National 

Center for Complementary and Alternative 

Medicine, 6707 Democracy Blvd., Bethesda, 

MD 20892.

Dated: September 10, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–21436 Filed 9–23–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.