57104 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 

that enter the market each year, the 

costs associated with the Rule’s 

disclosure requirements, beyond the 

additional labor costs discussed above, 

are de minimis. Negative option clubs 

already have access to the ordinary 

office equipment necessary to achieve 

compliance with the Rule. Similarly, the 

Rule imposes few, if any, printing and 

distribution costs. The required 

disclosures generally constitute only a 

small addition to the advertising for 

negative option plans. Because printing 

and distribution expenditures are 

incurred to market the product 

regardless of the Rule, adding the 

required disclosures results in marginal 

incremental expense. 

David C. Shonka, 

Acting General Counsel. 

[FR Doc. E8–23036 Filed 9–30–08: 8:45 am] 

[Billing code: 6750–01–S] 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Biodefense Science Board; 

Notification of a Public Teleconference 

AGENCY: Department of Health and 

Human Services, Office of the Secretary. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services is hereby giving notice that the 

National Biodefense Science Board 

(NBSB) will be holding a public 

teleconference. The meeting is open to 

the public. 

DATES: The NBSB will hold a public 

teleconference on October 14, 2008. The 

teleconference will be held from 10 a.m. 

to 11 a.m. EST. Public Conference Callin Number is available by contacting 

CAPT Leigh Sawyer (see below). 

Participants will be asked to provide 

their name, title, and organization. 

ADDRESSES: The conference will be 

conducted by phone. 

FOR FURTHER INFORMATION CONTACT: Any 

member of the public wishing to obtain 

general information concerning this 

public teleconference should contact 

CAPT Leigh A. Sawyer, D.V.M., M.P.H., 

Executive Director, National Biodefense 

Science Board, Office of the Assistant 

Secretary for Preparedness and 

Response, U.S. Department of Health 

and Human Services, e-mail at: 

leigh.sawyer@hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to section 319M of the Public Health 

Service Act (42 U.S.C. 247d–7f) and 

section 222 of the Public Health Service 

Act (42 U.S.C. 217a), the Department of 

Health and Human Services established 

the National Biodefense Science Board. 

The Board shall provide expert advice 

and guidance to the Secretary on 

scientific, technical, and other matters 

of special interest to the Department of 

Health and Human Services regarding 

current and future chemical, biological, 

nuclear, and radiological agents, 

whether naturally occurring, accidental, 

or deliberate. The Board may also 

provide advice and guidance to the 

Secretary on other matters related to 

public health emergency preparedness 

and response. 

Background: The purpose of the 

October 14, 2008 teleconference is to 

discuss recommendations from the 

Personal Preparedness Working Group 

and to ensure the public is provided 

opportunity to be involved in the 

deliberative process of the Board on 

personal preparedness issues that will 

specifically impact the Nation. The 

recommendations will include 

suggestions for evaluation of the prepositioning of Med-Kits for use 

following an exposure to anthrax. A 

special meeting of the Board is being 

convened to assure that the public is 

given the opportunity to provide 

comments on the proposed 

recommendations. There will be time 

for members of the public to present 

their comments to the Board on this 

subject matter. 

Availability of Materials: The agenda 

and other materials will be posted on 

the NBSB Web site at http:// 

www.hhs.gov/aspr/omsph/nbsb/ 

index.html prior to the meeting. 

Procedures for Providing Public Input: 

Interested members of the public may 

submit relevant written or oral 

information for the NBSB to consider. 

Oral Statements: In general, 

individuals or groups requesting an oral 

presentation at a public NBSB 

teleconference will be limited to three 

minutes per speaker, with no more than 

a total of 20 minutes for all speakers. To 

be placed on the public speaker list, you 

should notify the operator when you 

enter the call-in number. 

Dated: September 26, 2008. 

William C. Vanderwagen, 

Assistant Secretary for Preparedness and 

Response, U.S. Department of Health and 

Human Services. 

[FR Doc. E8–23144 Filed 9–29–08; 11:15 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Member 

Conflict Review, Program 

Announcement (PA) 07–318 

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 aforementioned meeting. 

Time and Date: 10 a.m.–12 p.m., November 

3, 2008 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of Member Conflict Review, PA 

07–318. 

Contact Person for More Information: Price 

Connor, Ph.D., Scientific Review Official, 

National Institute for Occupational Safety 

and Health, CDC, 2400 Century Center, 

Atlanta, GA 30333, Telephone (404) 498– 

2511. 

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: September 22, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–23098 Filed 9–30–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

Privacy Act of 1974; CMS Computer 

Match No. 2008–02 HHS Computer 

Match No. 0602 

AGENCY: Department of Health and 

Human Services (HHS), Centers for 

Medicare & Medicaid Services (CMS). 

ACTION: Notice of Computer Matching 

Program. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended, this notice establishes a 

computer matching agreement between 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57105 

CMS and the Department of Defense 

(DoD). We have provided background 

information about the proposed 

matching program in the 

SUPPLEMENTARY INFORMATION section 

below. The Privacy Act requires that 

CMS provide an opportunity for 

interested persons to comment on the 

proposed matching program. We may 

defer implementation of this matching 

program if we receive comments that 

persuade us to defer implementation. 

See ‘‘Effective Dates’’ section below for 

comment period. 

DATES: Effective Dates: CMS filed a 

report of the Computer Matching 

Program (CMP) with the Chair of the 

House Committee on Government 

Reform and Oversight, the Chair of the 

Senate Committee on Homeland 

Security and Governmental Affairs, and 

the Administrator, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB) on 09– 

24–2008. We will not disclose any 

information under a matching 

agreement until 40 days after filing a 

report to OMB and Congress or 30 days 

after publication, whichever is later. 

ADDRESSES: The public should address 

comments to: Walter Stone, CMS 

Privacy Officer, Division of Privacy 

Compliance (DPC), Enterprise 

Architecture and Strategy Group 

(EASG), Office of Information Services 

(OIS), CMS, Mail stop N2–04–27, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. Comments 

received will be available for review at 

this location, by appointment, during 

regular business hours, Monday through 

Friday from 9 a.m.—3 p.m., eastern 

daylight time. 

FOR FURTHER INFORMATION CONTACT: 

Walter Stone, CMS Privacy Officer, 

Division of Privacy Compliance (DPC), 

Enterprise Architecture and Strategy 

Group (EASG), Office of Information 

Services (OIS), CMS, Mail stop N2–04– 

27, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

SUPPLEMENTARY INFORMATION: 

I. Description of the Matching Program 

A. General 

The Computer Matching and Privacy 

Protection Act of 1988 (Pub. L. 100– 

503), amended the Privacy Act (5 U.S.C. 

552a) by describing the manner in 

which computer matching involving 

Federal agencies could be performed 

and adding certain protections for 

individuals applying for and receiving 

Federal benefits. 

Section 7201 of the Omnibus Budget 

Reconciliation Act of 1990 (Pub. L. 101– 

508) further amended the Privacy Act 

regarding protections for such 

individuals. The Privacy Act, as 

amended, regulates the use of computer 

matching by Federal agencies when 

records in a system of records are 

matched with other Federal, state, or 

local government records. It requires 

Federal agencies involved in computer 

matching programs to: 

1. Negotiate written agreements with 

the other agencies participating in the 

matching programs; 

2. Obtain the Data Integrity Board 

approval of the match agreements; 

3. Furnish detailed reports about 

matching programs to Congress and 

OMB; 

4. Notify applicants and beneficiaries 

that the records are subject to matching; 

and, 

5. Verify match findings before 

reducing, suspending, terminating, or 

denying an individual’s benefits or 

payments. 

B. CMS Computer Matches Subject to 

the Privacy Act 

CMS has taken action to ensure that 

all CMPs that this Agency participates 

in comply with the requirements of the 

Privacy Act of 1974, as amended. 

Dated: September 23, 2008. 

Charlene Frizzera, 

Chief Operating Officer, Centers for Medicare 

& Medicaid Services. 

CMS Computer Match No. 2008–02 

HHS Computer Match No. 0602 

NAME: 

‘‘Disclosure of Enrollment and 

Eligibility Information for Military 

Health System Beneficiaries Who are 

Medicare Eligible.’’ 

SECURITY CLASSIFICATION: 

Level Three Privacy Act Sensitive. 

PARTICIPATING AGENCIES: 

The Centers for Medicare & Medicaid 

Services (CMS); and Department of 

Defense (DoD), Manpower Data Center 

(DMDC), Defense Enrollment and 

Eligibility Reporting System Office 

(DEERS), and the Office of the Assistant 

Secretary of Defense (Health Affairs)/ 

TRICARE Management Activity (TMA). 

AUTHORITY FOR CONDUCTING MATCHING

PROGRAM: 

This CMA is executed to comply with 

the Privacy Act of 1974 (Title 5 United 

States Code (U.S.C.) § 552a), as 

amended, (as amended by Public Law 

(Pub. L.) 100–503, the Computer 

Matching and Privacy Protection Act of 

1988), the Office of Management and 

Budget (OMB) Circular A–130, titled 

‘‘Management of Federal Information 

Resources’’ at 61 Federal Register (FR) 

6435 (February 20, 1996), and OMB 

guidelines pertaining to computer 

matching at 54 FR 25818 (June 19, 

1989). 

Prior to 1991, CHAMPUS entitlement 

terminated when any individual became 

eligible for Medicare Part A on a nonpremium basis. The National Defense 

Authorization Act(s) (NDAA) for Fiscal 

Years (FY) 1992 and 1993 (Pub. L. 102– 

190) § 704, provide for reinstatement of 

CHAMPUS as second payer for 

beneficiaries entitled to Medicare on the 

basis of disability/End Stage Renal 

Disease (ESRD) only if they also enroll 

in Part B. 

This agreement implements the 

information matching provisions of the 

NDAA, FY 2001 (Pub. L. 106–398) 

Sections 711 and 712; the NDAA, FY 

1993 (Pub. L. 102–484) Section 705; and 

the NDAA, FY 1992 (Pub. L. 102–190) 

Sections 704 and 713. 

Section 732 of the FY 1996 NDAA 

(Pub. L. 104–106), directed the 

administering Secretaries to develop a 

mechanism for notifying beneficiaries of 

their ineligibility for CHAMPUS when 

loss of eligibility is due to disability 

status. 

PURPOSE(S) OF THE MATCHING PROGRAM: 

The purpose of this agreement is to 

establish the conditions, safeguards and 

procedures under which CMS will 

disclose Medicare enrollment 

information to the DoD, DMDC, DEERS, 

and Health Affairs/TMA. The disclosure 

by CMS will provide TMA with the 

information necessary to determine if 

Military Health System (MHS) 

beneficiaries (other than dependents of 

active duty personnel), who are 

Medicare eligible, are eligible to receive 

continued military health care benefits. 

This disclosure will provide TMA with 

the information necessary to meet the 

Congressional mandate outlined in 

legislative provisions in the NDAA 

listed above. 

Current law requires TMA to 

discontinue military health care benefits 

to MHS beneficiaries who are Medicare 

eligible and under the age of 65 when 

they become eligible for Medicare Part 

A because of disability/ESRD unless 

they are enrolled in Medicare Part B. 

Current law also requires TMA to 

provide health care and medical 

benefits to MHS beneficiaries who are 

Medicare eligible (commonly referred to 

as the dual eligible population) over the 

age of 65 who are enrolled in the 

supplementary medical insurance 

program under Part B of the Medicare 

program. This CMA will combine both 

groups of the MHS beneficiary 

population described above into one 


jlentini on PROD1PC65 with NOTICES
57106 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 

single database to more effectively carry 

out this matching program. In order for 

TMA to meet the requirements of 

current law, CMS agrees to disclose 

certain Part A and Part B enrollment 

data on this dual eligible population, 

which will be used to determine a 

beneficiary’s eligibility for care under 

CHAMPUS/TRICARE. DEERS will 

receive the results of the computer 

match and provide the information to 

TMA for use in its matching program. 

This computer matching agreement 

supersedes all existing data exchange 

agreements between CMS and DMDC 

applicable to the exchange of personal 

data for purposes of disclosing 

enrollment and eligibility information 

for MHS beneficiaries who are Medicare 

eligible. 

CATEGORIES OF RECORDS AND INDIVIDUALS

COVERED BY THE MATCH: 

DEERS will furnish CMS with an 

electronic file on a monthly basis 

extracted from the DEERS’ systems of 

records containing social security 

numbers (SSN) for all MHS beneficiaries 

who may also be eligible for Medicare 

benefits. CMS will match the DEERS 

finder file against its ‘‘Medicare 

Beneficiary Database’’ system of records 

(System No. 09–70–0536), and will 

validate the identification of the 

beneficiary and provide the Health 

Insurance Claim Number that matches 

against the SSN and date of birth 

provided by DEERS, and also provide 

the Medicare Part A entitlement status 

and Part B enrollment status of the 

beneficiary. CMS’s data will help TMA 

to determine a beneficiary’s eligibility 

for continued care under TRICARE. 

DEERS will receive the results of the 

computer match and provide the 

information provided to TMA for use in 

its program. 

DESCRIPTION OF RECORDS TO BE USED IN THE

MATCHING PROGRAM: 

DoD will use the SOR identified as 

S322.50, entitled ‘‘Defense Eligibility 

Records,’’ at 69 Federal Register (FR) 

33376 (June 15, 2004), as amended by 

69 FR 67118 (November 16, 2004). SSNs 

of DoD beneficiaries will be released to 

CMS pursuant to the routine use set 

forth in the system notice, which 

provides that data may be released to 

HHS ‘‘for support of the DEERS 

enrollment process and to identify 

individuals not entitled to health care.’’ 

Identification and Medicare status of 

DoD eligible beneficiaries will be 

provided to TMA to implement the 

statutory program. Therefore, eligibility 

information may also be maintained in 

the SOR identified as DHA 07, entitled 

‘‘Military Health Information System 

(MHIS),’’ at 70 FR 44574 (August 3, 

2005). 

The release of the data for CMS is 

covered under the ‘‘Enrollment 

Database,’’ System No. 09–70–0502 

published in the Federal Register at 73 

FR 10249 (February 26, 2008). Matched 

data will be released to DEERS pursuant 

to the routine use number 2 as set forth 

in the system notice. 

INCLUSIVE DATES OF THE MATCH: 

The Matching Program shall become 

effective no sooner than 40 days after 

the report of the Matching Program is 

sent to OMB and Congress, or 30 days 

after publication in the Federal 

Register, which ever is later. The 

matching program will continue for 18 

months from the effective date and may 

be renewed for an additional 12 month 

period as long as the statutory language 

for the match exists and other 

conditions are met. 

[FR Doc. E8–23080 Filed 9–30–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0499] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Implementation of 

Sections 222, 223, and 224 of the Food 

and Drug Administration Amendments 

Act of 2007 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the requirement established by Title II 

of the Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Public Law 110–85) that device 

establishments must submit registration 

and listing information by electronic 

means, using FDA Form 3673, unless 

the Secretary of the Department of 

Health and Human Services (the 

Secretary) grants them a waiver from the 

electronic submission requirement. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 1, 2008. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 


jlentini on PROD1PC65 with NOTICES