63838 Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

820.40 .............................................................. 8,924 1 8,924 9 80,316 

820.40(a) and (b) ............................................. 8,924 1 8,924 2 17,848 

820.50(a)(1) through (a)(3) .............................. 8,924 1 8,924 22 196,328 

820.50(b) .......................................................... 8,924 1 8,924 6 53,544 

820.6 ................................................................ 8,924 1 8,924 1 8,924 

820.65 .............................................................. 8,924 1 8,924 1 8,924 

820.70(a)(1) through (a)(5) .............................. 8,924 1 8,924 2 17,848 

820.70(b) and (c) ............................................. 8,924 1 8,924 2 17,848 

820.70(d) .......................................................... 8,924 1 8,924 3 26,772 

820.70(e) .......................................................... 8,924 1 8,924 2 17,848 

820.70(g)(1) through (g)(3) .............................. 8,924 1 8,924 1 8,924 

820.70(h) .......................................................... 8,924 1 8,924 2 17,848 

820.70(i) ........................................................... 8,924 1 8,924 8 71,392 

820.72(a) .......................................................... 8,924 1 8,924 5 44,620 

820.72(b)(1) and (b)(2) .................................... 8,924 1 8,924 1 8,924 

820.75(a) .......................................................... 8,924 1 8,924 3 26,772 

820.75(b) .......................................................... 8,924 1 8,924 1 8,924 

820.75(c) .......................................................... 8,924 1 8,924 1 8,924 

820.80(a) through (e) ....................................... 8,924 1 8,924 5 44,620 

820.86 .............................................................. 8,924 1 8,924 1 8,924 

820.90(a) .......................................................... 8,924 1 8,924 5 44,620 

820.90(b)(1) and (b)(2) .................................... 8,924 1 8,924 5 44,620 

820.100(a)(1) through (a)(7) ............................ 8,924 1 8,924 12 107,088 

820.100(b) ........................................................ 8,924 1 8,924 1 8,924 

820.120(b) ........................................................ 8,924 1 8,924 1 8,924 

820.120(d) ........................................................ 8,924 1 8,924 1 8,924 

820.130 ............................................................ 8,924 1 8,924 1 8,924 

820.140 ............................................................ 8,924 1 8,924 6 53,544 

820.150(a) and (b) ........................................... 8,924 1 8,924 6 53,544 

820.160(a) and (b) ........................................... 8,924 1 8,924 1 8,924 

820.170(a) and (b) ........................................... 8,924 1 8,924 2 17,848 

820.180(b) and (c) ........................................... 8,924 1 8,924 2 17,848 

820.181(a) through (e) ..................................... 8,924 1 8,924 1 8,924 

820.184(a) through (f) ...................................... 8,924 1 8,924 1 8,924 

820.186 ............................................................ 8,924 1 8,924 1 8,924 

820.198(a) through (c) ..................................... 8,924 1 8,924 5 44,620 

820.200(a) and (d) ........................................... 8,924 1 8,924 3 26,772 

820.25 .............................................................. 8,924 1 8,924 1 8,924 

Totals ........................................................ ............................ ............................ ............................ ............................ 3,105,552 

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

Dated: October 12, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26102 Filed 10–15–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0344] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Testing 

Communications on Medical Devices 

and Radiation-Emitting 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. 

DATES: Fax written comments on the 

collection of information by November 

17, 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–NEW and 

the title ‘‘Testing Communications on 

Medical Devices and Radiation-Emitting 

Products.’’ 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, 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. 

Testing Communications on Medical 

Devices and Radiation-Emitting 

Products—(OMB Control Number 0910– 

NEW) 

FDA is authorized by section 

1003(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)) to conduct educational 

and public information programs 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 63839 

relating to the safety of regulated 

medical devices and radiation-emitting 

products. FDA must conduct needed 

research to ensure that such programs 

have the highest likelihood of being 

effective. Improving communications 

about medical devices and radiationemitting products will involve many 

research methods, including individual 

indepth interviews, mall-intercept 

interviews, focus groups, selfadministered surveys, gatekeeper 

reviews, and omnibus telephone 

surveys. 

The information collected will serve 

three major purposes. First, as formative 

research it will provide critical 

knowledge needed about target 

audiences to develop messages and 

campaigns about medical device and 

radiation-emitting product use. 

Knowledge of consumer and health care 

professional decisionmaking processes 

will provide the better understanding of 

target audiences that FDA needs to 

design effective communication 

strategies, messages, and labels. These 

communications will aim to improve 

public understanding of the risks and 

benefits of using medical devices and 

radiation-emitting products by 

providing users with a better context in 

which to place risk information more 

completely. 

Second, as initial testing, it will allow 

FDA to assess the potential effectiveness 

of messages and materials in reaching 

and successfully communicating with 

their intended audiences. Testing 

messages with a sample of the target 

audience will allow FDA to refine 

messages while still in the 

developmental stage. Respondents will 

be asked to give their reaction to the 

messages in either individual or group 

settings. 

Third, as evaluative research, it will 

allow FDA to ascertain the effectiveness 

of the messages and the distribution 

method of these messages in achieving 

the objectives of the message campaign. 

Evaluation of campaigns is a vital link 

in continuous improvement of 

communications at FDA. 

Annually, FDA projects about 30 

studies using a variety of research 

methods and lasting an average of 0.17 

hours each (varying from 0.08–1.5 

hours). The operating and maintenance 

costs include contractor expenses for 

designing and conducting information 

collection activities, specifically, 

drawing samples, training interviewers, 

collecting and analyzing information, 

and reporting and disseminating 

findings. FDA estimates the burden of 

this collection of information based on 

prior recent experience with the various 

types of data collection methods 

described earlier. FDA is requesting this 

burden so as not to restrict the Agency’s 

ability to gather information on public 

sentiment for its proposals in its 

regulatory and communications 

programs. 

In the Federal Register of July 13, 

2010 (75 FR 39952), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment, however it was not related to 

the collection of information. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Anticipated data collection methods Number of respondents 

Annual frequency per response 

Total annual 

responses 

Hours per response Total hours 

Individual indepth interviews .............................................. 360 1 360 .75 270 

General public focus group interviews .............................. 144 1 144 1 .5 216 

Intercept interviews: Central location ................................. 600 1 600 .25 150 

Intercept interviews: Telephone ......................................... 10,000 2 1 10,000 .08 800 

Self-administered surveys .................................................. 2,400 1 2,400 .25 600 

Gatekeeper reviews ........................................................... 400 1 400 .50 200 

Omnibus surveys ............................................................... 2,400 1 2,400 .17 408 

Total (general public) .................................................. 16,304 16,304 2,644 

Physician focus group interviews ...................................... 144 1 144 1 .5 216 

Total (physician) ......................................................... 144 ........................ 144 .......................... 216 

Total (overall) ....................................................... 16,448 ........................ 16,448 .......................... 2,860 

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

2Brief interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1–800 number. 

Dated: October 13, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26119 Filed 10–15–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel: Notice of Charter 

Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel, Centers 

for Disease Control and Prevention, 

Department of Health and Human 

Services, has been renewed for a 2-year 

period through September 18, 2012. 

For information, contact Gladys G. 

Lewellen, M.B.A, M.P.A., Designated 

Federal Officer, Disease, Disability, and 

Injury Prevention and Control Special 

Emphasis Panel, Centers for Disease 

Control and Prevention, Department of 

Health and Human Services, 1600 

Clifton Road, NE., Mailstop E11, 

Atlanta, Georgia 30333, telephone (404) 

498–1519 or fax (404) 498–1541. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

mstockstill on DSKH9S0YB1PROD with NOTICES