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
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57107 

Implementation of Sections 222, 223, 

and 224 of the Food and Drug 

Administration Amendments Act of 

2007 (OMB Control Number 0910– 

0625)—Extension 

Sections 222, 223, and 224 of FDAAA, 

which were in effect on October 1, 2007, 

require that device establishment 

registrations and listings under section 

510 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360), (including the submission of 

updated information), be submitted to 

the Secretary by electronic means, 

unless the Secretary grants a request for 

waiver of the requirement because the 

use of electronic means is not 

reasonable for the person requesting the 

waiver. FDA expects 20,000 to 30,000 

device establishments to begin 

registering electronically at that time. 

Section 222 of FDAAA amends 

sections 510(b) of the FD&C Act to 

require domestic establishments to 

register annually during the period 

beginning October 1 and ending 

December 31 of each year. Section 222 

of FDAAA also amends section 510(i)(1) 

of the FD&C Act to require foreign 

establishments to register immediately 

upon first engaging in one of the 

covered device activities described 

under the statute, and in addition, they 

must also register annually during the 

time period beginning October 1 and 

ending December 31 of each year. 

Further, section 223 of FDAAA amends 

section 510(j)(2) of the FD&C Act to 

require establishments to list their 

devices with FDA annually, during the 

time period beginning October 1 and 

ending December 31 of each year. 

Under FDAAA, device establishment 

owners and operators are required to 

keep their registration and device listing 

information up-to-date using the 

agency’s new electronic system. Owners 

and operators of new device 

establishments must use the electronic 

system to create new accounts, new 

registration records, and new device 

listings. Section 224 of FDAAA amends 

section 510(p) of the FD&C Act by 

allowing an affected person to request a 

waiver from the requirement to register 

electronically when the ‘‘use of 

electronic means’’ is not reasonable for 

the person. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of 

the 2007 

Amendments 

FDA Form No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

2222 3673 2,600 1 2,704 0.5 1,352 

2232 3673 24,382 1 24,382 0.25 6,095 

2242 29,370 1 29,370 0.75 22,028 

2243 2,600 1 2,600 0.5 1,300 

224 (waiver 

request)2 20 1 20 1 20 

224 (waiver 

request)3 1 1 1 1 1 

Total Hours 30,796 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2One time burden. 

3Annual increase in burden. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Section of the 2007 Amendments No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours Per 

Record Total Hours 

2222 33,490 1 29,900 .25 7,475 

2232 16,524 4 66,096 .5 33,048 

Total Hours 40,523 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Recurring burden. 

The estimates in Table 1 of this 

document are based on FDA’s 

experience, data from the device 

registration and listing database, and 

our estimates of the time needed to 

complete the previously required forms. 

We estimate that the time needed to 

enter registration and listing 

information electronically using FDA 

Form 3673 will not differ significantly 

from the time needed to fill in the paper 

forms (FDA Forms 2891, 2891a, and 

2892) that previously were used for this 

purpose because the information 

required is essentially identical. 

In addition, under section 224 of 

FDAAA, device establishment owner/ 

operators, for whom registering and 

listing by electronic means is not 

reasonable, may request a waiver from 

the Secretary. Because a device 

establishment’s owner/operator is 

required to register and list, they would 

need only to have access to a computer, 

Internet and an e-mail address for 

registration and listing by electronic 

means, the agency did not anticipate 

receipt of a large number of requests for 

waiver. For the first few months of 

operation of the web-based system, from 


jlentini on PROD1PC65 with NOTICES
57108 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 

the October through December 2007 

timeframe, FDA received fewer than 10 

requests for waivers for the requirement 

to submit registration and listing 

information electronically. As data for 

more than 16,000 establishments have 

been received electronically for the 

same period, these requests amount to 

less than 1 percent of the total number 

of establishments that have responded. 

Based on information taken from our 

databases, FDA estimates that there are 

29,370 owner/operators who 

collectively register a total of 33,490 

device establishments. The number of 

respondents listed for section 224 of 

FDAAA in Table 1 of this document is 

29,370, which corresponds to the 

number of owner/operators who 

annually register one or more 

establishments. In addition, FDA 

estimates that 4,988 owner/operators are 

initial importers who must register their 

establishments but who, under FDA’s 

existing regulations, are not required to 

list their devices unless they initiate or 

develop the specifications for the 

devices or repackage or relabel the 

devices. The number of respondents 

included in Table 1 of this document for 

section 223 of FDAAA is 24,382, which 

corresponds to the number of owner/ 

operators who annually list one or more 

devices (29,370 - 4,988 = 24,382). 

To calculate the burden estimate for 

waiver requests under section 224 of 

FDAAA, we assume as stated 

previously, that less than one-tenth of 1 

percent of the 33,490 total device 

establishments would request waivers 

from FDA. This means the total number 

of waiver requests would probably not 

exceed 20 requests (33,490 x 0.0006). 

We also estimate that the one-time 

burden on these establishments would 

be an hour of time for a mid-level 

manager to draft, approve, and mail a 

letter. In addition, FDA estimates the 

total number of establishments will 

increase by 2,600 new establishments 

each year. Of the 2,600 new registrants 

each year, we assume that less than 1 

percent (i.e., 1) of these will also request 

waivers each year. The total, therefore, 

is 21 waiver requests, which could 

increase by only one additional request 

each year. 

The burden estimate for 

recordkeeping requirements under 

section 222 of FDAAA in Table 2 of this 

document, complies with the 

requirement that owners or operators 

keep a list of officers, directors, and 

partners for each establishment. Owners 

or operators will need to provide this 

information only upon request from 

FDA. However, it is assumed that some 

effort will need to be expended for 

keeping such lists current. 

The burden estimate for the 

recordkeeping requirements under 

section 223 of FDAAA in table 2 of this 

document reflect other recordkeeping 

requirements for devices listed with 

FDA, and the requirement to provide 

these records upon request from FDA. 

These estimates are based on FDA 

experience. 

Dated: September 25, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22989 Filed 9–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0512] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices: 

Humanitarian Use Devices 

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 

information collection requirements for 

Humanitarian Use Devices. 

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. 

Medical Devices: Humanitarian Use 

Devices—21 CFR Part 814 (OMB 

Control Number 0910–0332)—Extension 

This collection of information 

implements the humanitarian use 

device (HUD) provision of section 

520(m) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360j(m)) and subpart H, part 814 (21 

CFR part 814). Under section 520(m) of 

the act, FDA is authorized to exempt a 

HUD from the effectiveness 

requirements of sections 514 and 515 of 

the act (21 U.S.C. 360d and 360e) 

provided that the device: (1) Is used to 

treat or diagnose a disease or condition 

that affects fewer than 4,000 individuals 

in the United States; (2) would not be 

available to a person with such a disease 

or condition unless an exemption is 

granted, because there is no comparable 

device other than another HUD 

approved under this exemption that is 

available to treat or diagnose the disease 


jlentini on PROD1PC65 with NOTICES