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
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57109 

or condition; and (3) will not expose 

patients to an unreasonable or 

significant risk of illness or injury with 

the probable benefit to health from 

using the device outweighing the risk of 

injury or illness from its use. This takes 

into account the probable risks and 

benefits of currently available devices or 

alternative forms of treatment. 

The information collected will assist 

FDA in making determinations on the 

following: (1) Whether to grant HUD 

designation of a medical device; (2) 

exempt a HUD from the effectiveness 

requirements under sections 514 and 

515 of the act, provided that the device 

meets requirements set forth under 

section 520(m) of the act; and (3) 

whether to grant marketing approval(s) 

for the HUD. Failure to collect this 

information would prevent FDA from 

making a determination on the factors 

listed previously in this document. 

Further, the collected information 

would also enable FDA to determine 

whether the holder of a HUD is in 

compliance with the HUD provisions 

under section 520(m) of the act. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Response Total Hours 

814.102 14 1 14 40 560 

814.104 6 1 6 320 1,920 

814.106 6 2 12 50 600 

814.108 32 1 32 80 2,560 

814.116(e)(3) 1 1 1 1 1 

814.124(a) 5 1 5 1 5 

814.24(b) 4 1 4 2 8 

814.126(b)(1) 45 1 45 120 5,400 

Total 11,054 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers Annual Frequency per 

Recordkeeping Total Annual Records Hours per Record Total Hours 

814.126(b)(2) 45 1 45 2 90 

Total 90 

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

The number of respondents in Tables 

1 and 2 of this document are an average 

from data for the previous 3 years, i.e., 

FY 2005–2007. The number of annual 

reports submitted under § 814.126(b)(1) 

in Table 1 reflects an increase to 45 

respondents with approved HUD 

applications. Likewise, under 

§ 814.126(b)(2) in Table 2, the number of 

recordkeepers increased to 45. 

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 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: September 25, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22991 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–0506] 

Determination That ATROVENT 

(Ipatropium Bromide) Inhalation 

Solution and 10 Other Drug Products 

Were Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that the 11 drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Olivia Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6308, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 


jlentini on PROD1PC65 with NOTICES