Federal Register / Vol. 75, No. 92 / Thursday, May 13, 2010 / Notices 26963 

will be based on an updated version of 

the previously fielded paper-and-pencil 

survey instrument. The target 

population for the national survey is all 

facilities in the U.S. that use lower 

gastrointestinal flexible endoscopic 

equipment for the detection of 

colorectal cancer in adults. Information 

will be collected from a random sample 

of 1,440 facilities, stratified by U.S. 

Census region and urban/rural location. 

Additional state-level surveys will be 

conducted from approximately 2010– 

2012 and will include a census survey 

of up to 18 selected states, based on 

methodology employed with the 

previously fielded state-based survey. 

An average of 135 facilities will be 

selected to participate in each state. A 

total of approximately 1,680 completed 

state surveys will be collected over the 

three years of the project. 

Facilities will be recruited and 

screened through a telephone interview. 

Participation is voluntary. The 

information collection will inform 

planning efforts for national and state 

colorectal cancer screening. 

There are no costs to respondents 

other than their time. The total 

estimated burden hours are 732. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Medical Facilities that Perform CRC 

Screening.

National Survey Recruitment Interview ....... 700 1 5/60 

National SECAP Survey .............................. 480 1 35/60 

State Survey Recruitment Interview ............ 800 1 5/60 

State SECAP Survey .................................. 560 1 35/60 

Carol Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–11413 Filed 5–12–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0043] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on How to Use E-Mail to 

Submit a Request for a Meeting or 

Teleconference in Electronic Format to 

the Center for Veterinary Medicine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 14, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0452. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., P150– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on How to Use 

E-Mail to Submit a Request for a 

Meeting or Teleconference in Electronic 

Format to the Center for Veterinary 

Medicine—(OMB Control Number 

0910–0452)—Extension 

CVM holds meetings and/or 

teleconferences when a sponsor requests 

a presubmission conference under 21 

CFR 514.5, or requests a meeting to 

discuss general questions. Generally, 

meeting requests are submitted to CVM 

on paper. However, CVM now allows 

registered sponsors to submit 

information electronically, and to 

request meetings electronically, if they 

determine this is more efficient and 

time saving for them. CVM’s guidance 

on ‘‘How to Submit a Request for a 

Meeting or Teleconference in Electronic 

Format to CVM,’’ provides sponsors 

with the option to submit a request for 

a meeting or teleconference as an e-mail 

attachment by the Internet. The likely 

respondents are sponsors for new 

animal drug applications. 

In the Federal Register of February 5, 

2010 (75 FR 6035), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. 

In response, two comments were 

received. One comment was completely 

outside the scope of the notice and the 

other requested that FDA meet openly 

with industry rather than closed 

sessions. Neither comment addressed 

the paperwork involved in the 

information collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/ 

FDA Form 3489 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses2

Hours per 

Response Total Hours 

10.64 40 2.4 96 .08 7.7 

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

2Electronic submissions received between January 1, 2008, and December 31, 2008. 


sroberts on DSKD5P82C1PROD with NOTICES
26964 Federal Register / Vol. 75, No. 92 / Thursday, May 13, 2010 / Notices 

The number of respondents in table 1 

of this document is the number of 

sponsors registered to make electronic 

submissions (40). The number of total 

annual responses is based on a review 

of the actual number of such 

submissions made between January 1, 

2008, and December 31, 2008 (96 x 

hours per response (.08) = 7.7 total 

hours). 

Dated: May 10, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–11453 Filed 5–12–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0088] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reporting and 

Recordkeeping Requirements and 

Availability of Sample Electronic 

Products for Manufacturers and 

Distributors of Electronic Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by June 14, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0025. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, email: 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Reporting and Recordkeeping 

Requirements and Availability of 

Sample Electronic Products for 

Manufacturers and Distributors of 

Electronic Products (OMB Control 

Number 0910–0025)—Extension 

Under sections 532 through 542 of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360ii through 360ss), 

FDA has the responsibility to protect the 

public from unnecessary exposure of 

radiation from electronic products. The 

regulations issued under these 

authorities are listed in title 21 of the 

Code of Federal Regulations, chapter I, 

subpart J, parts 1000 through 1050 (parts 

1002 through 1050). 

Section 532 of the act directs the 

Secretary of the Department of Health 

and Human Services (the Secretary), to 

establish and carry out an electronic 

product radiation control program, 

including the development, issuance, 

and administration of performance 

standards to control the emission of 

electronic product radiation from 

electronic products. The program is 

designed to protect the public health 

and safety from electronic radiation, and 

the act authorizes the Secretary to 

procure (by negotiation or otherwise) 

electronic products for research and 

testing purposes and to sell or otherwise 

dispose of such products. Section 534(g) 

of the act directs the Secretary to review 

and evaluate industry testing programs 

on a continuing basis; and section 

535(e) and (f) of the act directs the 

Secretary to immediately notify 

manufacturers of, and ensure correction 

of, radiation defects or noncompliances 

with performance standards. Section 

537(b) of the act contains the authority 

to require manufacturers of electronic 

products to establish and maintain 

records (including testing records), 

make reports, and provide information 

to determine whether the manufacturer 

has acted in compliance. 

The regulations under parts 1002 

through 1010 specify reports to be 

provided by manufacturers and 

distributors to FDA and records to be 

maintained in the event of an 

investigation of a safety concern or a 

product recall. 

FDA conducts laboratory compliance 

testing of products covered by 

regulations for product standards in 

parts 1020, 1030, 1040, and 1050. 

FDA details product-specific 

performance standards that specify 

information to be supplied with the 

product or require specific reports. The 

information collections are either 

specifically called for in the act or were 

developed to aid the Agency in 

performing its obligations under the act. 

The data reported to FDA and the 

records maintained are used by FDA 

and the industry to make decisions and 

take actions that protect the public from 

radiation hazards presented by 

electronic products. This information 

refers to the identification of, location 

of, operational characteristics of, quality 

assurance programs for, and problem 

identification and correction of 

electronic products. The data provided 

to users and others are intended to 

encourage actions to reduce or eliminate 

radiation exposures. 

FDA uses the following forms to aid 

respondents in the submission of 

information for this information 

collection: 

• FDA Form 2579 ‘‘Report of 

Assembly of a Diagnostic X-Ray System’’ 

• FDA Form 2767 ‘‘Notice of 

Availability of Sample Electronic 

Product’’ 

• FDA Form 2877 ‘‘Declaration for 

Imported Electronic Products Subject to 

Radiation Control Standards’’ 

• FDA Form 3649 ‘‘Accidental 

Radiation Occurrence (ARO)’’ 

• FDA Form 3626 ‘‘A Guide for the 

Submission of Initial Reports on 

Diagnostic X-Ray Systems and Their 

Major Components’’ 

• FDA Form 3627 ‘‘Diagnostic X-Ray 

CT Products Radiation Safety Report’’ 

• FDA Form 3628 ‘‘General Annual 

Report (Includes Medical, Analytical, 

and Industrial X-Ray Products Annual 

Report)’’ 

• FDA Form 3629 ‘‘Abbreviated 

Report’’ 

• FDA Form 3630 ‘‘Guide for 

Preparing Product Reports on Sunlamps 

and Sunlamp Products’’ 

• FDA Form 3631 ‘‘Guide for 

Preparing Annual Reports on Radiation 

Safety Testing of Sunlamps and 

Sunlamp Products’’ 

• FDA Form 3632 ‘‘Guide for 

Preparing Product Reports on Lasers 

and Products Containing Lasers’’ 

• FDA Form 3633 ‘‘General Variance 

Request’’ 

• FDA Form 3634 ‘‘Television 

Products Annual Report’’ 

• FDA Form 3635 ‘‘Laser Light Show 

Notification’’ 

• FDA Form 3636 ‘‘Guide for 

Preparing Annual Reports on Radiation 

Safety Testing of Laser and Laser Light 

Show Products’’ 

• FDA Form 3637 ‘‘Laser Original 

Equipment Manufacturer (OEM) Report’’ 

• FDA Form 3638 ‘‘Guide for Filing 

Annual Reports for X-Ray Components 

and Systems’’ 


sroberts on DSKD5P82C1PROD with NOTICES