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

Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 6211 

1Available on the Internet at http://www.fda.gov/ 

downloads/Drugs/GuidanceComplianceRegulatory

Information/Guidances/ucm072229.pdf. 

related to look-alike and sound-alike 

proprietary names, unclear label 

abbreviations, acronyms, dose 

designations, and error-prone label and 

packaging designs. Among these 

measures, FDA agreed to publish 

guidance on the contents of a complete 

submission package for a proposed 

proprietary name for a drug/biological 

product. FDA also agreed to 

performance goals for review of 

proprietary names submitted during the 

investigational new drug application 

(IND) phase or with a new drug 

application (NDA) or biologics license 

application (BLA); the goals stipulate 

that a complete submission is required 

to begin the review clock. (See section 

IX.A of the goals letter at http:// 

www.fda.gov/ForIndustry/UserFees/ 

PrescriptionDrugUserFee/ 

ucm119243.htm). 

This proprietary names submission 

guidance is intended to promote 

prevention of medication errors by 

assisting industry in the submission of 

complete product information that will 

help FDA to evaluate the safety of 

proposed proprietary drug and 

biological product names, taking into 

account 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. 

This proprietary names submission 

guidance applies to prescription drug 

products, including biologics, that are 

the subject of an IND, NDA, abbreviated 

new drug application (ANDA), or BLA; 

and nonprescription drug products that 

are the subject of an IND, NDA, or 

ANDA. 

The proprietary names submission 

guidance does not address other 

performance goals under PDUFA IV, 

including developing FDA internal 

policies and procedures to ensure that 

proprietary name review goals are met; 

developing guidance on best practices 

for naming, labeling, and packaging 

drugs and biologics to reduce 

medication errors; developing guidance 

on proprietary name evaluation best 

practices; and developing and 

implementing a pilot program for 

evaluating proposed proprietary names. 

These performance goals are or will be 

addressed elsewhere. 

In the Federal Register of November 

24, 2008 (73 FR 71009), FDA announced 

the availability of a draft guidance for 

industry entitled ‘‘Contents of a 

Complete Submission for the Evaluation 

of Proprietary Names’’ and invited 

comments. Many comments discussed 

topics that were beyond the scope of the 

proprietary names submission guidance, 

including other performance goals 

under PDUFA IV that are addressed in 

other public dockets. These comments 

concerned the contents of any industrysponsored reviews and data for 

submission to FDA under the pilot 

program described in the FDA concept 

paper entitled ‘‘PDUFA Pilot Project 

Proprietary Name Review’’ (concept 

paper) (73 FR 58604, October 7, 2008). 

FDA acknowledges that information in 

the proprietary names submission 

guidance could be useful to participants 

in the voluntary pilot program for 

proprietary name review. However, the 

proprietary names submission guidance 

does not describe the information 

needed by FDA to evaluate proposed 

proprietary names under the pilot 

program. Rather, the purpose is limited 

to informing industry about what 

information is needed by FDA to 

evaluate proposed proprietary names 

within PDUFA IV goal dates under the 

traditional review process. We welcome 

submission of comments about the tools 

and methods FDA uses for its analysis 

of proposed proprietary names under 

the pilot program to docket number 

FDA–2008–N–0281. 

After considering comments on the 

draft guidance, FDA has issued the 

proprietary names submission guidance. 

Changes made to the guidance were 

editorial and primarily clarifying in 

response to comments. The revisions 

included: (1) Clarifying that the purpose 

of this guidance is to provide industry 

with a complete listing of the 

information FDA needs to evaluate a 

proposed proprietary name under the 

traditional review process; (2) adding 

the respective PDUFA IV review 

performance timeframes for complete 

submissions of a proposed proprietary 

name submitted during the IND phase 

or with an NDA, BLA, or supplement; 

and (3) referencing the concept paper1

for a complete discussion of the tools 

and methods used for FDA’s safety 

evaluation that are mentioned in the 

proprietary names submission 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 the contents of a 

complete submission for the evaluation 

of proprietary names. 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 statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

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. 

III. 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 312 and FDA Form 1571 

have been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information in 21 CFR part 601 and 

FDA Form 356h have been approved 

under OMB control number 0910–0338. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: February 3, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–2660 Filed 2–5–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Purified Inactivated Dengue 

Tetravalent Vaccine Containing a 

Common 30 Nucleotide Deletion in the 

3′-UTR of Dengue Types 1,2,3, and 4 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES