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
Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Notices 6733 

mode of administration. Cognitive 

interviewing provides useful 

information on questionnaire 

performance at minimal cost and 

respondent burden. Similar 

methodology has been adopted by other 

federal agencies, as well as by academic 

and commercial survey organizations. 

There are no costs to respondents other 

than their time. Frequency of Response: 

Once. Affected Public: Individuals or 

households. 

Type of respondents Project 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average burden hours per 

response 

Estimated 

annual burden 

hours 

requested 

Questionnaire Development Volunteers.(1) Survey questionnaire development.200 1 1.25 ................

(75 minutes) ...

250.0 

General Volunteers ........................... (2) Research on the cognitive aspects of survey methodology.100 1 1.25 ................

(75 minutes) ...

125.0 

Computer User Volunteers ............... (3) Research on computer-user 

interface design.

100 1 1.25 ................

(75 minutes) ...

125.0 

Household Interview Volunteers ....... (4) Pilot Household interviews ......... 200 1 0.5 ..................

(30 minutes) ...

100.0 

Total ........................................... ........................................................... 600 ........................ ........................ 600.0 

The estimated total annual burden 

hours requested is 600. There are no 

annualized costs to respondents. The 

annualized costs to the Federal 

Government are estimated at $264,000 

and include cost of NCI staff to plan, 

conduct, and analyze outcomes of 

questionnaire development, $50 

payment of pretest participants, 

contracting for pretesting activities and 

research, travel costs, and additional 

materials needed to conduct and recruit 

participants for the research. There are 

no Capital Costs, Operating Costs, and/ 

or Maintenance Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, New Executive 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. 

Gordon Willis, PhD., Cognitive 

Psychologist, Applied Research 

Program, DCCPS, NCI/NIH, 6130 

Executive Blvd., MSC 7344, EPN 4005, 

Bethesda, MD 20892 or call non-toll-free 

number 301–594–6652 or e-mail your 

request, including your address to: 

willis@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: January 28, 2008. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. E8–2029 Filed 2–4–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel MRI Imaging. 

Date: March 5, 2008. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Ruixia Zhou, PhD, 

Scientific Review Officer, 6707 Democracy 

Boulevard, Democracy Two Building, Suite 

957, Bethesda, MD 20892, (301) 496–4773, 

zhour@mail.nih.gov. 

Dated: January 29, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–481 Filed 2–4–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–129, Revision of an 

Existing Information Collection; 

Comment Request 

ACTION: 60-Day Notice of Information 

Collection Under Review: Form I–129, 

Petition for Nonimmigrant Worker; 

OMB Control Number 1615–0009. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services has submitted the 

following information collection request 

for review and clearance in accordance 

with the Paperwork Reduction Act of 


rmajette on PROD1PC64 with NOTICES