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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