Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 6209 

program is a success, there will be a 

new, proven resource available to health 

care providers to improve their ability to 

treat pain and addiction co-occurring in 

the provider’s patients. In order to 

evaluate the effectives of the program, 

information will be collected from 

health care providers before exposure to 

the web based materials (pre-test), after 

exposure to the web based materials 

(post-test), and 4–6 weeks after the 

program has been completed (followup). 

Frequency of Response: On occasion. 

Affected Public: Volunteer health care 

providers who treat patients with pain. 

Type of Respondents: Physicians, 

nurse practitioners, and physician 

assistants. 

The annual reporting burden is as 

follows: 

Estimated Number of Respondents: 

80. 

Estimated Number of Responses per 

Respondent: 3. 

Average Burden Hours per Response: 

0.75. 

Estimated Total Annual Burden 

Hours Requested: 180. 

The annualized cost to respondents is 

estimated at: $11,925. There are no 

Capital Costs, Operating Costs, and/or 

Maintenance Costs to report. 

Type of respondents 

Estimated 

number of respondents 

Estimated 

number of responses per 

respondent 

Average burden hours per 

response 

Estimated annual burden 

hours 

requested 

Physicians ........................................................................................................ 60 3 0.75 135

Other primary care providers (e.g., nurse practitioners, physician assistants) 20 3 0.75 45 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) 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) 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) 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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Scudder Quandra, 

Project Officer, NIH/NIDA/CCTN, Room 

3105, MSC 9557, 6001 Executive 

Boulevard, Bethesda, MD 20892–9557 

or e-mail your request, including your 

address to scudderq@nida.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: January 25, 2010. 

Mary Affeldt, 

Executive Officer (OM Director), NIDA. 

[FR Doc. 2010–2694 Filed 2–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–D–0410] (formerly 

Docket No. 2006D–0191) 

Guidance for Industry and Food and 

Drug Administration; Guidance for the 

Use of Bayesian Statistics in Medical 

Device Clinical Trials; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Guidance for the Use of Bayesian 

Statistics in Medical Device Clinical 

Trials.’’ This guidance summarizes 

FDA’s current thoughts on the 

appropriate use of Bayesian statistical 

methods in the design and analysis of 

medical device clinical trials. 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Guidance for the Use of 

Bayesian Statistics in Medical Device 

Clinical Trials’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

Bldg. 66, rm. 4617, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993 or to the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. Send one self-addressed 

adhesive label to assist that office in 

processing your request, or fax to CDRH 

at 301–847–8149. The guidance may 

also be obtained by mail by calling 

CBER at 1–800–835–4709 or 301–827– 

1800. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Submit written comments 

concerning this guidance to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. 

FOR FURTHER INFORMATION CONTACT: 

Greg Campbell, Center for Devices 

and Radiological Health, Bldg. 66, 

rm. 2110, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–5750; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852, 301–827– 

6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance outlines FDA’s current 

thinking on the use of Bayesian 

statistical methods in medical device 

clinical trials. Bayesian statistical 

methods are currently used in a variety 

of medical device applications to FDA. 

This guidance includes a general 

description of Bayesian methods, 

discussions on design and analysis of 

Bayesian medical device clinical trials, 

the benefits and difficulties with the 

Bayesian approach, and comparisons 

with standard (frequentist) statistical 

methods. Additionally, some ideas on 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

6210 Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 

using Bayesian methods in post-market 

studies are presented. 

The draft version of this document 

was issued on May 23, 2006, for 

comment. A public meeting to discuss 

the document was held on July 27, 

2006. FDA received several hundred 

specific comments on the guidance. 

There were many comments of a 

specific technical nature; for example, a 

set of comments regarding our 

discussion of prior distributions, the 

meaning of ‘‘non-informative’’ priors, 

and how we might evaluate the choice 

of a prior led us to make some changes 

and additions to the document. As 

another example, the central importance 

of the concept of ‘‘exchangeability’’ was 

revealed in some of the comments and 

has recently become more apparent; 

thus the discussion of exchangeability 

has been greatly expanded. Many 

comments of a more regulatory nature 

(e.g. specific issues regarding 

implementation of Bayesian methods in 

a regulatory setting) were also addressed 

in the revision. To the extent possible, 

editorial comments regarding the 

presentation of the statistical or 

technical issues and/or the writing were 

addressed. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on ‘‘Guidance for the 

Use of Bayesian Statistics in Medical 

Device Clinical Trials.’’ It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. To receive ‘‘Guidance for the 

Use of Bayesian Statistics in Medical 

Device Clinical Trials,’’ you may either 

send an e-mail request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1601 to identify the guidance 

you are requesting. A search capability 

for all CDRH guidance documents is 

available at http://www.fda.gov/Medical

Devices/DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov or the 

CBER Internet site at http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807 have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 812 have been approved under 

OMB number 0910–0078; the 

collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0485; and 

the collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), electronic or written 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: January 15, 2010. 

Jeffrey Shuren, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. 2010–2596 Filed 2–5–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0592] 

Guidance for Industry on the Contents 

of a Complete Submission for the 

Evaluation of Proprietary Names; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Contents of a Complete 

Submission for the Evaluation of 

Proprietary Names’’ (proprietary names 

submission guidance). This guidance 

provides recommendations to industry 

regarding the submission of a complete 

package that FDA intends to use to 

assess the safety of proposed proprietary 

names for drugs, including biological 

products, and other factors that, in 

association with the name, can 

contribute to medication errors. In 

addition, FDA intends to use this 

information in the assessment of 

promotional aspects of proposed 

proprietary names. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. Submit 

written comments on the guidance to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Carol Holquist, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4416, 

Silver Spring, MD 20993–0002, 301– 

796–2360; or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448, 301–827– 

6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Contents of a Complete Submission for 

the Evaluation of Proprietary Names.’’ In 

performance goals under the September 

27, 2007, reauthorization of the 

Prescription Drug User Fee Act (PDUFA 

IV), FDA agreed to implement various 

measures to reduce medication errors 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES