28706 Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Notices 

general campus climate around mental 

health and wellness. Faculty and staff 

will also describe their knowledge of 

prevention activities on campus and 

their perceived effectiveness of these 

efforts. Local campus staff will recruit 

appropriate respondents for the faculty 

and staff focus groups to include a 

maximum of 9 respondents per group. 

The total number of participants will 

not exceed 162 and groups will last 

approximately 90 minutes. 

• Case Study Key Informant 

Interviews (7 versions). The Case Study 

Key Informant Interviews (CSIs) include 

7 qualitative interview versions: (1) 

Administrator, (2) Counseling Staff, (3) 

Coalition Member—Faculty, (4) 

Prevention Staff, (5) Case Finder, (6) 

Campus Police, and (7) Student Leader. 

Local project staff will be responsible 

for identifying appropriate respondents 

for each CSI version and scheduling the 

interview to occur during site visits by 

the case study team. A total of 14 

interviews will be conducted during 

each campus site visit (a total of up to 

192 interviews). The case study team 

from Macro International Inc. will be 

responsible for administering the 

interviews and is trained in qualitative 

interviewing. Fourteen individuals from 

each of the campus sites will be selected 

as key informants to participate in the 

CSIs in the first and third stages of the 

GLS Campus Case Studies, for a total of 

64 respondents. Questions on the CSIs 

include whether respondents are aware 

of suicide prevention activities, what 

the campus culture is, related to suicide 

prevention, and what specific efforts are 

in place to prevent suicide among the 

campus population. Items are formatted 

as open-ended and semi-structured 

questions. The CSIs include 16 to 21 

items and will take approximately 60 

minutes to complete. On the second site 

visit, the case study team will 

incorporate preliminary findings from 

the case studies in the interviews, 

which may be modified to some extent 

to collect more comprehensive 

information and gather feedback from 

local key informants surrounding the 

context of the preliminary findings. The 

CSIs for the second site visit will last 60 

minutes. 

The average annual respondent 

burden is estimated below. This project 

is scheduled to be completed in 12 

months; thus, the table reflects the total 

burden for one year, the project length. 

The estimate reflects the total annual 

respondents for the project (at which 

time the CCS would conclude), the 

average annual number of respondents, 

the average annual number of responses, 

the time it will take for each response, 

and the average burden. 

TOTAL AND ANNUAL AVERAGES: RESPONDENTS, RESPONSES AND HOURS

Measure name Number of 

respondents 

Number of 

responses per 

respondent 

Hours/ 

response 

Response 

burden 

Enhanced Module ............................................................................................ 1,200 1 0.17 204 

Focus Group—Student Version ....................................................................... 324 1 1.5 486 

Focus Group—Faculty Version ....................................................................... 108 1 1.5 162 

Focus Group—Staff Version ............................................................................ 54 1 1.5 81 

Interview—Student Leader Version ................................................................. 12 1 1 12 

Interview—Case Finder Version ...................................................................... 6 1 1 6 

Interview—Faculty Version .............................................................................. 12 1 1 12 

Interview—Campus Police Version ................................................................. 12 1 1 12 

Interview—Counseling Staff Version ............................................................... 12 1 1 12 

Interview—Prevention Staff Version ................................................................ 18 1 1 18 

Interview—Administrator Version ..................................................................... 12 1 1 12 

Total .......................................................................................................... 1,770 1,017 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by July 17, 2009 to: SAMHSA 

Desk Officer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–6974. 

Dated: June 8, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–14218 Filed 6–16–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0648] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; PDUFA Pilot 

Project Proprietary Name Review 

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 July 17, 

2009. 

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: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

the title ‘‘PDUFA Pilot Project 

Proprietary Name Review.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 


dwashington3 on PROD1PC60 with NOTICES
Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Notices 28707 

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. 

PDUFA Pilot Project Proprietary Name 

Review 

In the Federal Register of October 7, 

2008 (73 FR 58604), FDA announced the 

availability of a concept paper entitled 

‘‘PDUFA Pilot Project Proprietary Name 

Review.’’ The concept paper describes 

how pharmaceutical firms may evaluate 

proposed proprietary names and submit 

the data generated from those 

evaluations to FDA for review under a 

pilot program to begin by the end of 

fiscal year (FY) 2009. 

On September 27, 2007, the President 

signed into law the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85, 121 Stat. 823), 

which includes the reauthorization and 

expansion of the Prescription Drug User 

Fee Act (PDUFA IV). As part of the 

reauthorization of PDUFA IV, FDA 

committed to certain performance goals, 

including the goal of using user fees to 

implement various measures to reduce, 

among other things, medication errors 

related to look-alike and sound-alike 

product proprietary names. FDA also 

agreed to develop and implement a 

voluntary pilot program to enable 

pharmaceutical firms participating in 

the pilot to evaluate proposed 

proprietary names and to submit the 

data generated from those evaluations to 

the FDA for review. The concept paper 

is intended to help pharmaceutical 

firms choose appropriate proprietary 

names for their drug and biological 

products before submitting marketing 

applications to FDA and describes how 

pharmaceutical firms may use ‘‘best 

practices’’ to carry out their own 

proprietary name reviews and provide 

FDA with the data that result from those 

reviews. The goals of the concept paper 

and the voluntary pilot program are to 

minimize the use of names that are 

misleading or that are likely to lead to 

medication errors, to make FDA’s 

marketing application review more 

efficient, and to make regulatory 

decisions more transparent. The concept 

paper explains how an applicant who 

chooses to participate in the pilot 

program could assess a proposed 

proprietary name for safety (i.e., 

potential for medication errors) and, at 

the applicant’s option, for promotional 

implications, before marketing 

application approval and subsequent 

marketing of a drug or biological 

product in the United States, and how 

to submit the results of the assessment 

for review under the pilot program. 

The information described in the 

concept paper and the data collected 

may not be submitted to FDA until OMB 

has approved the information collection 

associated with the pilot program. After 

OMB approval, FDA will accept 

requests to register for the pilot 

program. FDA will announce OMB’s 

approval and other details on 

participating in the pilot program in the 

Federal Register. FDA expects that the 

pilot program will begin by the end of 

FY 2009. 

The information collection that will 

result from the voluntary pilot program, 

as described in the concept paper, 

consists of the following: 

1. Applicants should contact FDA to 

register and indicate the approximate 

date of their proprietary name 

submission, as described in the concept 

paper and as will be described in more 

detail when FDA announces OMB’s 

approval and the specific information 

on participating in the pilot program. 

2. Applicants should contact the 

appropriate FDA center 120 days prior 

to the intended date of the proposed 

proprietary name submission to discuss 

the specific details of the planned 

submission. Applicants should 

communicate with the Director in the 

Division of Medication Error Prevention 

and Analysis in the Office of 

Surveillance and Epidemiology in the 

Center for Drug Evaluation and 

Research, or the Branch Chief at the 

Advertising and Promotion Labeling 

Branch of the Division of Case 

Management in the Office of 

Compliance and Biologics Quality in the 

Center for Biologics Evaluation and 

Research, concerning any questions 

about their proposed submissions. For 

prescription products, applicants 

should inform the appropriate center at 

the 120-day pre-submission discussion 

if they plan to use alternative or 

additional methods to evaluate the 

safety of their proposed proprietary 

name. For nonprescription products, 

sponsors should discuss with FDA 

different protocols that could be used 

for their specific drug products prior to 

the submission of the proprietary name. 

3. Applicants should submit two 

separate sets of product name-related 

information to enable parallel reviews 

by FDA as follows: (a) A comprehensive 

evaluation of the proposed proprietary 

name including the information and 

data listed in Appendix B (‘‘Proposed 

Template For A Pilot Program 

Submission’’) of the concept paper; and 

(b) the proprietary name information 

that they would ordinarily submit under 

FDA’s current practice. (Note: The 

proprietary name information ordinarily 

submitted under FDA’s current practice 

is not included in the estimates in table 

1 of this document because this 

information collection is already 

approved under OMB Control Numbers 

0910–0001 and 0910–0338). 

4. After review of the proprietary 

name submissions, and if FDA informs 

the applicant that the proposed firstchoice proprietary name is 

unacceptable, the applicant should 

confirm in writing that it would like its 

originally submitted second-choice 

name reviewed, or the applicant should 

submit an alternative second-choice 

name along with the information 

described in the concept paper. At that 

time, FDA will begin review of the 

second-choice name. If an applicant has 

submitted a complete proprietary name 

analysis for the second-choice name, the 

responsible center will use discretion to 

determine whether to review the 

applicant’s analysis in addition to 

conducting its own analysis using the 

traditional approach. Although FDA 

would ideally review the applicant’s 

completed proprietary name analysis for 

the second-choice name, factors such as 

staffing and timelines will be used in 

making this determination. 

Comment and Related Issues 

In the Federal Register of December 

23, 2008 (73 FR 78813), FDA published 

a 60-day notice requesting comments on 

the information collection. We received 

one comment, which raised the 

following issues: 

1. The comment stated that the focus 

of the Pilot Program should be on safety 

evaluations for drug products that will 

be marketed in the United States. The 

comment said that trademark clearance 

from both the legal and regulatory 

perspectives is often conducted by 

sponsors to support the geographic 

markets for the product and therefore 

often extends beyond the United States. 

The comment said it is not uncommon 

for pharmaceutical companies to 

develop trademarks that will be granted 

registrations from trademark offices in 

connection with approvals from health 

authorities in multiple countries with 

the goal of becoming global trademarks. 

Except for product names in foreign 

markets that are identical to the 

trademark under review, the comment 

recommended that FDA limit its 

requests for search data to clearance 

activities relating to trademarks that are 

in use or appear likely from public 

sources to be in use in the near future 

in the United States. The comment said 

that data from outside the United States 

can be voluminous and are not 

necessary for the proper performance of 

FDA’s functions or for determining the 


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28708 Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Notices 

appropriateness of the name in the 

United States. 

The comment also expressed concern 

with ‘‘FDA’s proposed broad request for 

trademark search-related information 

insofar as they apply to all search 

queries.’’ (The comment referenced 

bullet points on pages 14 and 36 of the 

concept paper). The comment said that 

FDA underestimates the burden of 

collecting such information. At the early 

stages of trademark clearance, the 

comment noted that a sponsor generally 

begins with a list that could include 

hundreds of candidates, and that this 

list is typically narrowed in successive 

waves of more in-depth searches of 

candidates based on legal and regulatory 

concerns. The comment said that 

because a sponsor cannot determine in 

advance which of the candidates on the 

initial list will survive the clearance 

process, sponsors would have to 

maintain the records of the early-stage, 

en masse searches relating to possibly 

hundreds of names on the list to comply 

with a request for all search queries. The 

comment said that sponsors should not 

be expected to maintain search query 

information for en masse search 

investigations on name candidates, 

especially those which had been 

eliminated previously and well before 

submission to FDA as proposed 

trademarks. It also asserted companies’ 

entitlement to maintain applicable legal 

privileges for information and 

communications developed in the 

course of trademark availability 

assessment. 

2. The comment also said that 

medication errors can be caused by any 

number of system failures or other 

causes at any one or more stages in the 

process of prescribing, dispensing, and 

administering medications, and that 

medication errors are the result of 

multiple causes. The comment said that 

there is no scientifically valid and 

reliable method for measuring the extent 

to which pharmaceutical proprietary 

names might contribute to the risk of 

such errors or whether such methods 

could ever adequately take into account 

the subjectivity and complexity of 

human perception. It also stated that the 

agency’s proprietary name review 

process must be guided by the first 

amendment. 

3. The comment noted that the burden 

of the collection of information should 

be minimized by using various 

automated collection techniques and 

other forms of information technology, 

and referred to the computerized 

databases listed in Attachment A of the 

concept paper. The comment said that 

some of the databases listed have 

limited value because they are 

substantially redundant with the 

collective content of the remaining 

databases, are not amenable to 

automated searching, or have more 

limited automated searching capabilities 

than others. The comment also noted 

that some sponsors may not have the 

resources to subscribe to many 

databases and will have to rely on the 

search capabilities of vendors, and 

questioned whether vendors that offer 

search services include all of the 

sources listed on Attachment A of the 

concept paper. 

FDA Response 

To evaluate the proposed information 

collection, FDA believes it is important 

to recall that the information collection 

not only supports the agency’s statutory 

mandates to ensure that drugs are safe 

and effective and are not misbranded, 

but also that it is part of a voluntary 

pilot program intended to make FDA’s 

regulatory decisions more transparent 

and to explore ways to make FDA’s 

application review more efficient. As 

indicated in the concept paper, FDA 

committed to this program in 

conjunction with the reauthorization of 

PDUFA IV, after extensive discussion 

with industry, to support the goals of 

reducing medication errors related to 

look-alike and sound-alike proprietary 

names, unclear label abbreviations, 

acronyms, dose designations, and errorprone label and packaging designs. 

The pilot program is intended not 

only to minimize the use of names that 

are misleading or that are likely to lead 

to medication errors, but also to provide 

a basis for FDA to determine whether in 

the future, it would be feasible and 

preferable for FDA to achieve these 

goals through review of analyses of 

proprietary names conducted and 

submitted by applicants, as many 

applicants have suggested, rather than 

conducting its own analyses, as is the 

current practice. To this end, the 

proposed information collection 

recommended in the pilot program is 

largely modeled on the information that 

FDA itself currently generates and 

analyzes in evaluating proposed 

proprietary names, in accordance with 

its statutory authorities and the first 

amendment. FDA requests that these 

elements be submitted by pilot program 

participants because of its own direct 

experience supporting the utility of 

such information, but as the pilot 

program concept paper makes clear, 

applicants can still participate in the 

pilot program if they plan to deviate 

from the proposed proprietary name 

safety evaluation methods 

recommended in the concept paper and 

instead use alternative or additional 

methods. Also, to the extent that the 

comment also suggests that the 

information collection for the pilot 

program should also be limited to 

information related to safety concerns, 

we note that applicants can participate 

in the pilot program without submitting 

any information to evaluate the 

promotional implications of their 

proposed proprietary names. 

With Regard to the Specific Elements of 

the Comment 

1. FDA does not seek to expand the 

burden of collecting trademark searchrelated information, and is not 

requesting that sponsors submit broad 

trademark search queries or other 

search-related screening information 

about any preliminary or early-stage 

proprietary name candidates which the 

sponsor eliminated from consideration 

and therefore did not submit to FDA for 

review as part of the proprietary name 

pilot program. 

FDA is interested in collecting all 

search queries that are specific to the 

proposed proprietary name a sponsor 

submits to the pilot program for review, 

including all existing, publicly available 

drug names initially identified as a 

potential source of confusion with 

respect to the proposed name. 

Specifically, FDA requests that a 

sponsor submit all of the search queries 

that were generated only for the specific 

proposed proprietary name submitted to 

FDA. For each query, the results are 

dependent upon how each data source 

was searched. 

Thus, in order for FDA to evaluate the 

strength of the results, information 

pertaining to each query, such as—the 

system parameters that were used for 

each search; the precise databases that 

were searched; any thresholds imposed 

on the output; the date the search was 

conducted or the last update of the 

database searched; the pooled results 

with source citation and full product 

characteristics of each name identified 

as a possible source of confusion with 

the proposed name—should be 

provided on the proposed name 

submitted to FDA for evaluation. 

Providing FDA with all of the search 

queries relevant to the proposed name 

and associated tests, including the 

Failure Mode and Effects Analysis, will 

permit FDA to understand and evaluate 

the basis for the sponsor’s conclusions 

that existing drug names that are 

identical or potentially similar to the 

proposed proprietary name would not 

be likely to cause confusion and 

medication errors. By submitting this 

information, the sponsor would be 

supporting the goals of the concept 

paper and the voluntary pilot program. 


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Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Notices 28709 

Such goals include not only minimizing 

the use of names that are misleading or 

that are likely to lead to medication 

errors in the clinical setting (due to 

look-alike and sound-alike proprietary 

names), but also include allowing FDA 

to evaluate whether to have applicants 

perform their own name analysis and 

submit resulting data to FDA for review. 

At the conclusion of the pilot 

program, FDA will be evaluating what 

information would be most useful as the 

basis of those industry-conducted 

proprietary name reviews. These 

evaluations will be largely qualitative. 

The results of the pilot program and 

recommended additions and changes to 

methods based on the reported results 

will be discussed in a future public 

meeting. With regard to the comment 

addressing legal privilege related to 

trademark evaluations, as noted 

previously, applicants can participate in 

the voluntary pilot program even if they 

deviate from the proposed proprietary 

name safety evaluation methods 

recommended in the concept paper, and 

therefore may determine for themselves 

how to submit useful information 

without compromising legal privileges 

related to trademark. 

FDA also acknowledges that ‘‘search 

data’’ for trademark clearance activities 

collected from outside the United States 

can be voluminous, particularly if 

sponsors are seeking to register a single 

global trademark for their drug in 

multiple countries. As already indicated 

FDA is not seeking broad trademark 

clearance search data but is interested in 

information specifically relevant to 

assessing the potential for medication 

error related to the specific proprietary 

name proposed for the United States. 

For this purpose, FDA agrees that the 

most relevant information includes 

information identifying product names 

in foreign markets that are identical to 

the name proposed for the U.S. market, 

regardless of active ingredient or other 

product characteristic. 

In addition, FDA agrees that it is 

important to collect information 

regarding phonological or orthographic 

similarities between the proposed name 

and foreign drug names that are in use 

or appear likely from public sources to 

be in use in the near future in the 

United States; such names should be 

considered in the same way as the 

names of any other drug products also 

in use in the United States. 

FDA believes that in certain 

circumstances, however, it is in the 

interest of public health for sponsors to 

provide the agency with other data that 

they may possess that indicates close 

similarities in spelling and 

pronunciation between the proprietary 

name proposed for the U.S. and foreign 

drug names. For example, patients in 

the United States may experience 

medication errors related to confusion 

of the names of a drug marketed in the 

United States and one obtained from a 

foreign country, either while the patient 

was abroad or through other means, 

whether or not the foreign drug is 

intended for the U.S. market by the 

manufacturer. This potential situation 

presents a particular public health risk 

where a drug product is currently 

marketed in a foreign country under a 

proprietary name which is identical or 

very similar to the proposed proprietary 

drug name under FDA review, but the 

drugs contain a different active 

ingredient. FDA therefore believes it is 

useful and supportive of the agency’s 

drug safety mandates to encourage the 

submission of such data in the pilot 

program. 

2. Concerning the comment that there 

is no scientifically valid and reliable 

method for measuring the extent to 

which pharmaceutical proprietary 

names might contribute to the risk of 

medication errors, FDA agrees that 

medication errors can be caused by any 

number of system failures or other 

contributing factors at any one or more 

stages in the medication use system, and 

that medication errors may be the result 

of multiple causes, many of which are 

not easily controllable. However, 

proprietary product names have been 

widely recognized as one important 

contributing source of medication 

errors, and one that is amenable to 

control. In the U.S. healthcare system, 

healthcare practitioners rely on a 

product’s name as the critical identifier 

of the appropriate therapy in a market 

of thousands of products. Although 

review of proprietary names will not 

eliminate all medication errors, it can 

help reduce the risk of such errors by 

identifying and eliminating a 

contributing factor prior to drug 

approval. The Institute of Medicine 

(IOM) has repeatedly recognized that 

medication use errors may occur due to 

sound-alike or look-alike names, unclear 

labels, or poorly designed packaging 

and are pivotal causes of these systemwide problems (To Err is Human— 

Building a Safer Health System (2000) 

and Preventing Medication Errors 

(2006)). (See section II.A. of the concept 

paper for a brief summary of pertinent 

IOM conclusions). In 2007 Congress 

responded to these IOM findings, and as 

part of the reauthorization of PDUFA IV, 

mandated FDA’s collection and use of 

user fees for, among other things, the 

review of drug applications and drug 

safety activities, in support of which 

FDA committed to meet performance 

goals, several of which highlighted the 

importance of considering proprietary 

names as a potential source of 

medication errors. These PDUFA IV 

goals, communicated to Congress, 

include FDA’s commitment to 

implement this pilot program as one 

measure to help reduce medication 

errors related to look-alike and soundalike proprietary names. 

FDA has acknowledged in three 

public meetings on proprietary drug 

review (held in June 2003, December 

2003, and June 2008) that there is no 

gold standard for testing proprietary 

drug product names to assess the risk of 

medication error. At the public 

technical meeting held in June 2008, 

topics included subsequent review of 

developments in the science and 

practice of proprietary name analysis 

since the 2003 meetings, the strength of 

evidence for the current approaches to 

name review for prescription and 

nonprescription products, and in the 

absence of a gold standard, the elements 

of best practices in testing. At the June 

2008 public meeting, all of the proposed 

evaluation methods were judged by 

individual experts participating in the 

public meeting to be complementary 

and were considered to offer value in 

the name testing process. As discussed 

in section IV of the concept paper, in 

the absence of a gold standard, FDA 

emphasizes that the best approach has 

proved to be the use of a combination 

of tests to evaluate name 

appropriateness. The concept paper 

contains FDA’s current thinking on the 

logistics and name testing and 

evaluation under the pilot program. 

However, docket number FDA–2008–N– 

0281 remains open for comment during 

the pendency of the pilot program and 

FDA invites comments on human 

factors testing. In addition, after 

accruing 2 years of experience with 

pilot program submissions, including 

reviewing applicants’ name analyses 

that use alternative methodologies, FDA 

is committed to publish draft guidance 

on best test practices for proprietary 

name review following public 

consultation with industry, academia, 

and others from the general public. 

Thus, the pilot program, in which 

participants are free to propose and 

provide results of alternate 

methodologies for name assessment, is 

in part intended to help inform 

potential future program modifications 

and changes in information collected to 

help prevent medication error. 

3. Concerning the comment that some 

of the databases listed in the concept 

paper have limited value because of 

redundancy with the collective content 


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28710 Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Notices 

of the remaining databases, and because 

they are not amenable to automated 

searching or have more limited 

automated searching capabilities than 

others, FDA understands that there may 

be some overlap across some of the 

databases and/or some limitation to 

automated search capabilities. However, 

as discussed in section IV.A.3. of the 

concept paper, the majority of names 

with similarity to the proposed 

proprietary name can be identified 

through database searches, and a variety 

of publicly available databases and 

resources containing product names can 

be used to identify similar names. FDA 

itself uses databases, the Internet, and 

other printed and electronic drug 

product resources to search for 

orthographic and phonological name 

similarities. The concept paper 

recommends that applicants search a 

variety of sources and, at a minimum, 

search the publicly available databases 

listed in Appendix A of the concept 

paper ‘‘Computerized Resources’’ 

because these databases are ones that 

FDA itself uses and considers the 

information in these references useful 

screening tools if properly searched. If 

a name appears in more than one 

database, it is acceptable to list the 

name once and list the sources along 

with the identified name. In addition, in 

most cases, the computerized resources 

listed in Appendix A are publicly 

available, including the Phonetic 

Orthographic Computer Analysis 

(POCA) software (see FDA’s notice of 

availability in the Federal Register of 

February 17, 2009 (74 FR 7450). As part 

of the pilot program, FDA encourages 

sponsors to identify any new databases 

or those databases which are more 

amenable to automated searching. 

FDA estimates the burden of this 

collection of information in table 1 of 

this document. The ‘‘Hours Per 

Response’’ is for all of the submissions 

and notifications to FDA described 

previously under paragraphs 1 to 4 in 

this document, and is based on 

information provided by industry as 

well as FDA’s familiarity with the time 

required for this information collection 

as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Number of 

Respondents 

Number of Responses 

per Respondent 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

Pilot Project Proprietary 

Name Review 20 1 20 480 9,600 

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

Dated: June 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–14212 Filed 6–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of meetings of the National 

Advisory Mental Health Council. 

The meetings 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 Advisory 

Mental Health Council. 

Date: July 17, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Conference Room D, Rockville, 

MD 20852. (Telephone Conference Call). 

Contact Person: Jane A. Steinberg, PhD, 

Director, Division of Extramural Activities, 

National Institute of Mental Health, NIH, 

Neuroscience Center, 6001 Executive Blvd., 

Room 6154, MSC 9609, Bethesda, MD 20892– 

9609. 301–443–5047. 

Name of Committee: National Advisory 

Mental Health Council. 

Date: August 14, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Conference Room D, Rockville, 

MD 20852. (Telephone Conference Call). 

Contact Person: Jane A. Steinberg, PhD, 

Director, Division of Extramural Activities, 

National Institute of Mental Health, NIH, 

Neuroscience Center, 6001 Executive Blvd., 

Room 6154, MSC 9609, Bethesda, MD 20892– 

9609. 301–443–5047. 

Name of Committee: National Advisory 

Mental Health Council. 

Date: September 9, 2009. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Conference Room D, Rockville, 

MD 20852. (Telephone Conference Call). 

Contact Person: Jane A. Steinberg, PhD, 

Director, Division of Extramural Activities, 

National Institute of Mental Health, NIH, 

Neuroscience Center, 6001 Executive Blvd., 

Room 6154, MSC 9609, Bethesda, MD 20892– 

9609. 301–443–5047. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards., National 

Institutes of Health, HHS) 

Dated: June 9, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–14087 Filed 6–16–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Health Marketing 

(BSC, NCHM) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), CDC announces the 

following meeting of the 

aforementioned committee: 

Times and Dates: 

9 a.m.–5 p.m., July 14, 2009. 


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