78426 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

Applications (RFA)/Program 

Announcements (PA)’’ soliciting 

proposals for individual research 

projects of $500,000 or more in total 

(direct and indirect) costs per year 

require the applicant to include a plan 

describing how the final research data 

will be shared/released or explain why 

data sharing is not possible. Details on 

data sharing and release, including 

information on the timeliness of the 

data and the name of the project data 

steward, should be included in a brief 

paragraph immediately following the 

Research Plan Section of the PHS 398 

form. References to data sharing and 

release may also be appropriate in other 

sections of the application (e.g.

background and significance, or human 

subjects requirements). The content of 

the data sharing and release plan will 

vary, depending on the data being 

collected and how the investigator is 

planning to share the data. The data 

sharing and release plan will not count 

towards the application page limit and 

will not factor into the determining 

scientific merit or the priority scoring. 

Investigators should seek guidance from 

their institutions on issues related to 

institutional policies, and local IRB 

rules, as well as local, state and federal 

laws and regulations, including the 

Privacy Rule. 

Further detail on the requirements for 

addressing data sharing in applications 

for NCIPC funding may be obtained by 

contacting NCIPC program staff or by 

visiting the NCIPC Internet Web site at: 

http://www.cdc.gov/ncipc/osp/

sharing_policy.htm.

VI.3. Reporting 

You must provide CDC with an 

original, plus two hard copies of the 

following reports: 

1. Interim progress report, (use form 

PHS 2590, OMB Number 0925–0001, 

rev. 5/2001 as posted on the CDC Web 

site) no less than 90 days before the end 

of the budget period. The progress 

report will serve as your non-competing 

continuation application, and must 

contain the following elements: 

a. Current Budget Period Activities 

Objectives. 

b. Current Budget Period Financial 

Progress. 

c. New Budget Period Program 

Proposed Activity Objectives. 

d. Detailed Line-Item Budget and 

Justification. 

e. Measures of Effectiveness. 

f. Additional Requested Information. 

2. Financial status report, no more 

than 90 days after the end of the budget 

period.

3. Final financial and performance 

reports, no more than 90 days after the 

end of the project period. 

These reports must be mailed to the 

Grants Management Specialist listed in 

the ‘‘Agency Contacts’’ section of this 

announcement. 

VII. Agency Contacts 

We encourage inquiries concerning 

this announcement. 

For general questions, contact: 

Technical Information Management 

Section, CDC Procurement and Grants 

Office, 2920 Brandywine Road, Atlanta, 

GA 30341, Telephone: 770–488–2700. 

For scientific/research issues, contact: 

Charlene Baker, PhD, Centers for 

Disease Control and Prevention, 4770 

Buford Highway, NE, MS K–60, Atlanta, 

GA 30341, Telephone: 770–488–1737, 

E-mail: asu6@cdc.gov.

For questions about peer review, 

contact: Gwendolyn Cattledge, PhD, 

Scientific Review Administrator, 

National Center for Injury Prevention 

and Control, Centers for Disease Control 

and Prevention (CDC), 4770 Buford 

Highway, NE., Mailstop K–02, 

Telephone: 770–488–1430, E-mail: 

gxc8@cdc.gov.

For financial, grants management, or 

budget assistance, contact: James 

Masone, Grants Management Specialist, 

CDC Procurement and Grants Office, 

2920 Brandywine Road, Atlanta, GA 

30341, E-mail: JMasone@cdc.gov.

VIII. Other Information 

This and other CDC funding 

opportunity announcements can be 

found on the CDC Web site, Internet 

address: http://www.cdc.gov. Click on 

‘‘Funding’’ then ‘‘Grants and 

Cooperative Agreements.’’

Dated: December 23, 2004. 

William P. Nichols, 

Acting Director, Procurement and Grants 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–28619 Filed 12–29–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Council for the Elimination of 

Tuberculosis Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following council 

meeting.

Name: Advisory Council for the 

Elimination of Tuberculosis (ACET). 

Times and Dates: 8:30 a.m.–5 p.m., 

February 16, 2005; 8:30 a.m.–12 p.m., 

February 17, 2005. 

Place: Corporate Square, Building 8, 1st 

Floor Conference Room, Atlanta, Georgia 

30333. Telephone (404) 639–8008. 

Status: Open to the public, limited only by 

the space available. The meeting room 

accommodates approximately 100 people. 

Purpose: This council advises and makes 

recommendations to the Secretary, 

Department of Health and Human Services; 

the Assistant Secretary for Health; and the 

Director, CDC, regarding the elimination of 

tuberculosis (TB). Specifically, the Council 

makes recommendations regarding policies, 

strategies, objectives, and priorities; 

addresses the development and application 

of new technologies; and reviews the extent 

to which progress has been made toward 

eliminating TB. 

Matters to be Discussed: Agenda items 

include issues pertaining to Global TB 

epidemiology and public health response, 

nucleic acid amplification testing (NAAT), 

and other TB related topics. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information:

Paulette Ford-Knights, National Center for 

HIV, STD, and TB Prevention, 1600 Clifton 

Road, NE., M/S E–07, Atlanta, Georgia 30333, 

telephone (404) 639–8008. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both CDC and the Agency for Toxic 

Substances and Disease Registry.

Dated: December 20, 2004. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention.

[FR Doc. 04–28615 Filed 12–29–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2490–N] 

CLIA Program; Continued Approval of 

the American Association of Blood 

Banks for Deeming Authority

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Notice.

SUMMARY: This notice announces the reapproval of the American Association of 

Blood Banks (AABB) as an accrediting 

organization for clinical laboratories 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program. The initial exemption 

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 78427

was published in the Federal Register

on July 21, 1995. We have determined 

that the accreditation process of this 

organization provides reasonable 

assurance that a laboratory accredited 

by it meets the conditions required by 

Federal law and regulations. 

Consequently, laboratories that are 

voluntarily accredited by the AABB and 

continue to meet the AABB 

requirements will be deemed to meet 

the CLIA condition-level requirements 

for laboratories and therefore are not 

subject to routine inspection by State 

survey agencies to determine their 

compliance with Federal requirements. 

They are, however, subject to validation 

and complaint investigation surveys 

conducted by us or our designee.

EFFECTIVE DATE: This notice is effective 

for the period July 21, 2001 through July 

21, 2007.

FOR FURTHER INFORMATION CONTACT:

Daralyn Hassan, (410) 786–9360.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA), Pub. L. 100–578. CLIA replaced 

in its entirety section 353(e)(2) of the 

Public Health Service Act, as enacted by 

the Clinical Laboratories Improvement 

Act of 1967. We issued a final rule (57 

FR 33992) implementing the 

accreditation provisions of CLIA on July 

31, 1992. Under the CLIA program, we 

may approve a private, nonprofit 

organization as an approved 

accreditation organization to accredit 

clinical laboratories if the organization 

meets certain requirements. An 

organization’s requirements for 

accredited laboratories must be equal to, 

or more stringent than, the applicable 

CLIA program requirements in 42 CFR 

part 493 (Laboratory Requirements). 

The regulations listed in subpart E of 

part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption Under an Approved State 

Laboratory Program) specify the 

requirements an organization must meet 

to be an approved accreditation 

organization. We approve an 

accreditation organization for a period 

not to exceed 6 years. 

In general, the approved accreditation 

organization must: 

• Use inspectors qualified to evaluate 

laboratory performance and agree to 

inspect laboratories with the frequency 

determined by us. 

• Apply standards and criteria that 

are equal to or more stringent than those 

condition-level requirements 

established by us. 

• Provide reasonable assurance that 

its accredited laboratories continually 

meet these standards and criteria. 

• Provide us with the name of any 

laboratory that has had its accreditation 

denied, suspended, withdrawn, limited, 

or revoked within 30 days of the action 

taken. 

• Notify us at least 30 days before 

implementing any proposed change in 

its standards. 

• If we withdraw our approval, notify 

the accredited laboratories of the 

withdrawal within 10 days of the 

withdrawal. 

CLIA requires CMS to perform an 

annual evaluation by inspecting a 

sufficient number of laboratories 

accredited by an approved accreditation 

organization as well as by any other 

means that we determine appropriate.

II. Notice of Approval of AABB as an 

Accrediting Organization 

In this notice, we approve AABB as 

an organization that may continue to 

accredit laboratories for purposes of 

establishing their compliance with CLIA 

requirements. We have examined the 

AABB application and all subsequent 

submissions to determine equivalency 

with our requirements under subpart E 

of part 493 that an accreditation 

organization must meet to be approved 

under CLIA. We have determined that 

AABB complied with the applicable 

CLIA requirements and grant AABB 

approval as an accreditation 

organization under subpart E, through 

July 21, 2007, for the following 

specialties and subspecialty areas: 

• Immunohematology. 

• General immunology. 

• Hematology. 

• Routine chemistry. 

• Toxicology. 

As a result of this determination, any 

laboratory that is accredited by the 

AABB during the effective time period 

for an approved specialty or 

subspecialty listed above is deemed to 

meet the CLIA requirements for 

laboratories found in part 493 of our 

regulations for that specialty or 

subspecialty and, therefore, is not 

subject to routine inspection by a State 

survey agency to determine its 

compliance with CLIA requirements. 

The accredited laboratory, however, is 

subject to validation and complaint 

investigation surveys performed by us, 

or by any other validly authorized agent. 

III. Evaluation of the AABB Request for 

Approval as an Accreditation 

Organization under CLIA 

The AABB formally applied to us for 

approval as an accreditation 

organization under CLIA for the 

specialties of immunohematology, 

hematology, general immunology, and 

the subspecialties of routine chemistry 

and toxicology. We evaluated the AABB 

application to determine compliance 

with our implementing and enforcement 

regulations, and the deeming/exemption 

requirements of the CLIA rules. 

We evaluated the application to verify 

assurance of the AABB’s compliance 

with the following subparts of part 493: 

• Subpart H, Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing. 

• Subpart J, Facility Administration 

for Nonwaived Testing. 

• Subpart K, Quality System for 

Nonwaived Testing. 

• Subpart M, Personnel for 

Nonwaived Testing. 

• Subpart Q, Inspections. 

• Subpart R, Enforcement Procedures.

The AABB meets the requirements for 

subparts H, J, K, M, Q, and R. 

We also verified the organization’s 

assurance that it requires the 

laboratories it accredits to be, and that 

the organization is, in compliance with 

the following subparts of part 493 as 

explained below: 

Subpart E—Accreditation by a Private, 

Nonprofit Accreditation Organization 

or Exemption Under an Approved State 

Laboratory Program 

The AABB submitted a list of all 

specialties and subspecialties that it 

would accredit; a comparison of 

individual accreditation and conditionlevel requirements; a description of its 

inspection process; proficiency testing 

(PT) monitoring process; its data 

management and analysis system; a 

listing of the size, composition, 

education and experience of its 

inspection teams; its investigative and 

complaint response procedures; its 

notification agreements with CMS; its 

removal or withdrawal of laboratory 

accreditation procedures; its current list 

of accredited laboratories; and its 

announced or unannounced inspection 

process. 

The AABB has additional 

requirements pertaining to waived 

testing. The AABB will routinely 

inspect laboratories that perform waived 

tests that are normally associated with 

blood centers and transfusion services. 

These laboratories will be inspected for 

good manufacturing practices and to 

verify that tests are performed according 

to manufacturer’s instructions. In 

addition, for waived testing, the AABB 

requires that there be appropriately 

qualified personnel that is, director, 

supervisor, and testing personnel. 

Section 493.15 of the CL1A regulations 

78428 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

requires only that a laboratory follow 

manufacturer’s instructions and does 

not require routine inspections of 

waived testing. Thus, the requirements 

of the AABB are more stringent than the 

requirements of the CLIA regulations. 

We have determined that the AABB 

has complied with the requirements 

under subpart E of part 493 and that the 

requirements of the AABB are equal to 

or more stringent than the conditionlevel requirements in subparts H, J, K, 

M, Q, and R of part 493. 

Subpart H—Participation in Proficiency 

Testing for Laboratories Performing 

Nonwaived Testing 

The AABB has revised its 

requirements to be equal to or more 

stringent than the CLIA requirements at 

§ 493.801 through § 493.865. 

Subpart J—Facility Administration for 

Nonwaived Testing 

The AABB has revised its 

requirements to be equal to or more 

stringent than the CLIA requirements at 

§ 493.1100 through § 493.1105. For 

example, the AABB requires 

laboratories to retain quality assessment 

records for five years, while the CLIA 

regulations require laboratories to retain 

these records for only two years. 

Subpart K—Quality System for 

Nonwaived Testing 

The quality control (QC) requirements 

of the AABB have been evaluated 

against the requirements of the CLIA 

regulations. The AABB has modified its 

survey process and made revisions to its 

standards encompassing general QC as 

well as specialty and subspecialty QC 

requirements in order to reflect the new 

QC requirements in the CLIA 

regulations. As such, we have 

determined that the AABB’s 

requirements are equal to or more 

stringent than the requirements in the 

CLIA regulations. The specific 

requirements that are more stringent 

than the requirements of the CLIA 

regulations are the following: 

• The requirement that laboratories 

meet the AABB’s QC requirements for 

all waived testing they perform. 

• The requirement for compliance 

with standards for parentage testing. 

• The AABB’s requirement that 

laboratories that perform providerperformed microscopy procedures must 

meet the same certification 

requirements as all other laboratories 

that perform moderate complexity 

testing.

Subpart M—Personnel for Nonwaived 

Testing 

The AABB has revised its 

requirements to equal the CLIA 

requirements at § 493.1403 through 

§ 493.1495 for laboratories that perform 

moderate and high complexity testing. 

The AABB personnel standards provide 

that the laboratory must meet CLIA 

requirements for personnel 

qualifications. The CLIA requirements 

for personnel responsibilities are 

encompassed in the revisions made to 

the AABB standards. 

Subpart Q—Inspections 

We have determined that the AABB’s 

requirements for inspections are equal 

to or more stringent than the 

requirements of § 493.1771 through 

§ 493.1780 of this subpart. 

Subpart R—Enforcement Procedures 

The AABB meets the requirements of 

subpart R to the extent it applies to 

accreditation organizations. The AABB 

policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, the 

AABB will deny, suspend, or revoke 

accreditation in a laboratory accredited 

by the AABB and report that action to 

CMS within 30 days. The AABB also 

provides an appeals process for 

laboratories that have had accreditation 

denied, suspended, or revoked. 

We have determined that the AABB’s 

laboratory enforcement and appeal 

policies are equal to or more stringent 

than the requirements of this part 493 

subpart R as they apply to accreditation 

organizations. 

IV. Federal Validation Inspection and 

Continuing Oversight 

The Federal validation inspections of 

AABB accredited laboratories may be 

conducted on a representative sample 

basis or in response to substantial 

allegations of noncompliance (that is, 

complaint inspections). The outcome of 

those validation inspections, performed 

by us or our agent, or the State survey 

agency, will be our principal means for 

verifying that the laboratories accredited 

by AABB remain in compliance with 

CLIA requirements. This Federal 

monitoring is an ongoing process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that CMS 

may rescind the approval of an 

accreditation organization, such as that 

of the AABB, for cause, before the end 

of the effective date of approval. If we 

determine that the AABB failed to adopt 

requirements that are equal to, or more 

stringent than, the CLIA requirements, 

or that systemic problems exist in its 

inspection process, we may give it a 

probationary period, not to exceed one 

year, to allow the AABB to adopt 

comparable requirements. 

Should circumstances result in our 

withdrawal of the AABB’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

In accordance with the provisions of 

Executive Order 12866, the Office of 

Management and Budget did not review 

this notice because our publication of 

this notice is not a regulatory action 

under that Executive Order.

Authority: Section 353 of the Public Health 

Service Act (42 U.S.C.263a).

Dated: November 16, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 04–28152 Filed 12–29–04; 8:45 am] 

BILLING CODE 3410–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9024–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—July 2004 Through 

September 2004

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Notice.

SUMMARY: This notice lists CMS manual 

instructions, substantive and 

interpretive regulations, and other 

Federal Register notices that were 

published from July 2004 through 

September 2004, relating to the 

Medicare and Medicaid programs. This 

notice provides information on national 

coverage determinations (NCDs) 

affecting specific medical and health 

care services under Medicare. 

Additionally, this notice identifies 

certain devices with investigational 

device exemption (IDE) numbers 

approved by the Food and Drug 

Administration (FDA) that potentially 

may be covered under Medicare. 

Finally, this notice also includes listings 

of all approval numbers from the Office 

of Management and Budget for 

collections of information in CMS 

regulations. 

Section 1871(c) of the Social Security 

Act requires that we publish a list of