Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Notices 6731 

hours. These figures have been rounded 

up. The burden estimates cited in tables 

1 and 2 of this document are based 

primarily upon the data and methods 

provided in FDA’s assessment for fiscal 

year (FY) 1999 entitled ‘‘A Cost 

Assessment of Medical Device 

Tracking.’’ Using implantation 

procedures from the National Center for 

Health Statistics, FDA applied a 2- 

percent annual growth rate to estimate 

the number of procedures for tracked 

implant devices for FY1997 through 

FY2006. This assessment also used unit 

shipment data in combination with 

various growth rates to estimate annual 

sales distribution for the tracked l/s-l/s 

devices over the same time period. In 

addition, the assessment also estimated 

the burden on industry for developing 

and maintaining tracking systems for 

these medical devices for FY1997 

through FY2006. 

For the annual recordkeeping burden, 

the number of respondent medical 

device manufacturers subject to device 

tracking is estimated to be 229 and is 

based on data from FDA’s 

manufacturers database. FDA issued 

tracking orders to 20 additional medical 

device manufacturers during the time 

period for FY2002 through FY2004. 

Under § 821.25(c), the additional 

medical device manufacturers 

collectively bear a one-time 

recordkeeping burden of 10,560 hours to 

develop a medical device tracking 

system. FDA’s estimate of 17,000 

medical device distributor respondents 

contained in this assessment, are 

derived from Dun & Bradstreet sources 

on medical equipment wholesalers, 

retailers, home care dealers, and rental 

companies. Health Forum, an American 

Hospital Association Company, 

provided statistics on hospitals. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

Dated: January 30, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–2078 Filed 2–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2008N–0016] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Additional Listing 

Information for Medical Device 

Registration and Listing 

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 public 

comments on the reporting and 

recordkeeping burden associated with 

the paperwork requirements under 

§ 807.31 (21 CFR 807.31), which 

requires device establishments to retain 

and, upon FDA’s specific request, 

submit certain additional listing 

information. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 7, 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 the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

1472 

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. 

Additional Listing Information for 

Medical Device Registration and 

Listing—21 CFR 80.31; (OMB Control 

Number 0910–0387)—Extension 

The Food and Drug Administration 

Amendments Act of 2007 (the 2007 

Amendments), enacted September 27, 

2007, requires that device establishment 

registrations and listings under 21 

U.S.C. 360(p) (including the submission 

of updated information), be submitted to 

the Secretary of Health and Human 

Services (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. See section 224 of the 2007 

Amendments. The 2007 Amendments 

provides for an October 1, 2007, 

effective date by which FDA expects 

approximately 30,000 establishments to 

begin registering. FDA is seeking OMB 

approval for the information collected 

by electronic means. Registration by 

electronic means for device 

establishments will mean replacement 

of FDA Forms 2891 and 2891a, 

‘‘Registration of Device Establishment’’

and FDA Form 2892 ‘‘Medical Device 

Listing,’’ with electronic versions. 

However, for OMB approval of the 

extension request for this collection of 


rmajette on PROD1PC64 with NOTICES
6732 Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Notices 

information, FDA is revising the scope 

to address only the reporting and 

recordkeeping requirements by nonelectronic means as described in this 

document and set forth under § 807.31 

for ‘‘ Additional Listing Information.’’

To reflect the revised scope of this 

collection of information, FDA has 

modified the title. 

Under § 807.31(a) through (d), each 

owner or operator is required to 

maintain an historical file containing 

the labeling and advertisements in use 

on the date of initial listing, and in use 

after October 10, 1978, but before the 

date of initial listing. The owner or 

operator must maintain in the historical 

file any labeling or advertisements in 

which a material change has been made 

anytime after initial listing, but may 

discard labeling and advertisements 

from the file 3 years after the date of the 

last shipment of a discontinued device 

by an owner or operator. Along with the 

recordkeeping requirements, under 

§ 807.31(e), the owner or operator must 

be prepared to submit to FDA copies of 

: (1) All device labeling, (2) all device 

labeling and representative advertising, 

or (3) only representative package 

inserts, depending upon whether the 

device is subject to the regulatory 

controls under Sections 514 or 515 of 

Federal Food, Drug, and Cosmetic Act 

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

respectively), or restrictions imposed by 

21 CFR 801.109 or otherwise by section 

520(e) of the act. 

The information collected under these 

provisions is used by FDA to identify: 

(1) Firms subject to FDA’s regulations, 

(2) geographic distribution in order to 

effectively allocate FDA’s field 

resources for these inspections, and (3) 

the class of the device that determines 

the frequency of inspection. As a result, 

when complications occur with a 

particular device or component, all 

manufacturers of similar or related 

devices can easily be identified. 

The likely respondents to this 

information collection are domestic and 

foreign device establishments who must 

register and submit a device list to FDA, 

e.g., establishments engaged in the 

manufacture, preparation, propagation, 

compounding, assembly, or processing 

of medical devices intended for human 

use and commercial distribution. 

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 

of Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

807.31(e) 200 1 200 .50 100 

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 

of Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

807.31(a) through (d ) 16,200 4 64,800 .50 32,400 

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

The annual respondent reporting 

burden for device establishment 

registrations and listing is estimated to 

be 100 hours and the annual respondent 

recordkeeping burden is estimated to be 

32,400 hours. The estimates cited in 

tables 1 and 2 of this documet are based 

primarily on the annual FDA 

accomplishment report, which includes 

actual FDA registration and listing data 

derived for fiscal year (FY) 2006. These 

estimates are also based on FDA 

estimates of FY 2006 data from current 

systems and conversations with 

industry and trade association 

representatives. FDA anticipates 

reviewing annually, 200 historical files. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through the FDMS only. 

Dated: January 30, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–2079 Filed 2–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review: 

Comment Request Questionnaire 

Cognitive Interview and Pretesting 

(ARP/DCCPS/NCI) 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute (NCI), the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on November 26, 2007 (Vol. 72, 

No. 226, p. 65969) and allowed 60 days 

for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Institutes of Health may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Proposed Collection: Title: 

Questionnaire Cognitive Interview and 

Pretesting. Type of Information 

Collection Request: New. Need and Use 

of Information Collection: The purpose 

of the data collection is to conduct 

cognitive interviews, focus groups, Pilot 

household interviews, and experimental 

research in laboratory and field settings, 

both for applied questionnaire 

evaluation and more basic research on 

response errors in surveys. The most 

common evaluation method is the 

cognitive interview, in which a 

questionnaire design specialist 

interviews a volunteer participant. The 

interviewer administers the draft survey 

questions as written, but also probes the 

participant in depth about 

interpretations of questions, recall 

processes used to answer them, and 

adequacy of response categories to 

express answers, while noting points of 

confusion and errors in responding. 

Interviews are generally conducted in 

small rounds of 10–15 interviews. When 

possible, cognitive interviews are 

conducted in the survey’s intended 


rmajette on PROD1PC64 with NOTICES