Federal Register / Vol. 75, No. 14 / Friday, January 22, 2010 / Notices 3739 

www.cfsan.fda.gov/~comm/ 

expcllst.html, which identifies U.S. 

dairy product manufacturers/processors 

that have expressed interest to FDA in 

exporting dairy products to Chile, are 

subject to FDA jurisdiction, and are not 

the subject of a pending judicial 

enforcement action (i.e., an injunction 

or seizure) or a pending warning letter. 

The term ‘‘dairy products,’’ for purposes 

of this list, is not intended to cover the 

raw agricultural commodity raw milk. 

Application for inclusion on the list is 

voluntary. However, Chile has advised 

that dairy products from firms not on 

this list could be delayed or prevented 

by Chilean authorities from entering 

commerce in Chile. The guidance 

explains what information firms should 

submit to FDA in order to be considered 

for inclusion on the list and what 

criteria FDA intends to use to determine 

eligibility for placement on the list. The 

document also explains how FDA 

intends to update the list and how FDA 

intends to communicate any new 

information to Chile. Finally, the 

guidance notes that FDA considers the 

information on this list, which is 

provided voluntarily with the 

understanding that it will be posted on 

FDA’s Web site and communicated to, 

and possibly further disseminated by, 

Chile, to be information that is not 

protected from disclosure under 5 

U.S.C. 552(b)(4). Under the guidance, 

FDA recommends that U.S. firms that 

want to be placed on the list send the 

following information to FDA: (1) Name 

and address of the firm and the 

manufacturing plant; (2) name, 

telephone number, and e-mail address 

(if available) of the contact person; (3) 

a list of products presently shipped and 

expected to be shipped in the next 3 

years; (4) identities of agencies that 

inspect the plant and the date of last 

inspection; (5) plant number and copy 

of last inspection notice; and (6) if other 

than an FDA inspection, copy of last 

inspection report. FDA requests that this 

information be updated every 2 years. 

In the Federal Register of June 4, 2009 

(74 FR 26867), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

FDA received two letters in response, 

each containing one or more comments. 

The comments were outside the scope 

of the comment request in the notice. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

New written requests to be 

placed on the list 15 1 15 1 .5 23 

Biannual update 88 1 88 1 .0 88 

Occasional updates 25 1 25 0 .5 13 

Total 124 

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

The estimate of the number of firms 

that will submit new written requests to 

be placed on the list, biannual updates 

and occasional updates is based on the 

FDA’s experience maintaining the list 

over the past 4 years. The estimate of 

the number of hours that it will take a 

firm to gather the information needed to 

be placed on the list or update its 

information is based on FDA’s 

experience with firms submitting 

similar requests. FDA believes that the 

information to be submitted will be 

readily available to the firms. 

To date, over 175 producers have 

sought to be included on the list. FDA 

estimates that, each year, approximately 

15 new firms will apply to be added to 

the list. We estimate that a firm will 

require 1.5 hours to read the guidance, 

gather the information needed, and to 

prepare a communication to FDA that 

contains the information and requests 

that the firm be placed on the list for a 

total of 22.5 hours, rounded to 23. 

Under the guidance, every 2 years each 

producer on the list must provide 

updated information in order to remain 

on the list. FDA estimates that each year 

approximately half of the firms on the 

list, 88 firms (175 x 0.5 = 87.5, rounded 

to 88), will resubmit the information to 

remain on the list. We estimate that a 

firm already on the list will require 1.0 

hours to biannually update and 

resubmit the information to FDA, 

including time reviewing the 

information and corresponding with 

FDA, for a total of 88 hours. In addition, 

FDA expects that, each year, 

approximately 25 firms will need to 

submit an occasional update and each 

firm will require 0.5 hours to prepare a 

communication to FDA reporting the 

change, for a total of 12.5 hours, 

rounded to 13. 

Dated: January 15, 2010. 

David Dorsey 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–1153 Filed 1–21–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 


erowe on DSK5CLS3C1PROD with NOTICES
3740 Federal Register / Vol. 75, No. 14 / Friday, January 22, 2010 / Notices 

Proposed Project: Advanced Education 

Nursing Traineeship (AENT) and Nurse 

Anesthetist Traineeship (NAT) (OMB 

No. 0915–0305) [Extension] 

The Health Resources and Services 

Administration (HRSA) provides 

training grants to educational 

institutions to increase the number of 

advanced education nurses through the 

Advanced Education Nursing 

Traineeship (AENT) Program and the 

Nurse Anesthetist Traineeship (NAT) 

Program. 

HRSA developed the AENT and NAT 

tables for the application guidances and 

the Nurse Traineeship Database for the 

two nursing traineeship programs. The 

AENT and NAT tables are used 

annually by grant applicants that are 

applying for AENT and NAT funding. 

The funds appropriated for the AENT 

and NAT programs are distributed 

among eligible institutions based on a 

formula. Award amounts are based on 

enrollment and graduate data reported 

on the tables and two funding factors 

(Statutory Funding Preference and 

Statutory Special Consideration). 

The AENT and NAT tables include 

information on program participants 

such as the number of enrollees, 

projected data on enrollees and 

graduates for the following academic 

year, number of trainees supported, 

number of graduates, number of 

graduates supported and the types of 

programs they are enrolling into and/or 

from which they are graduating. AENT 

and NAT applicants will have a single 

access point to submit their grant 

applications including the tables. 

Applications are submitted in two 

phases: Grants.gov (Phase 1) and the 

HRSA Electronic Handbooks (Phase 2). 

These tables will be available 

electronically through the HRSA 

Electronic Handbooks (Phase 2) for 

applicants to submit their AENT and/or 

NAT grant application(s). The tables are 

also used in the Nurse Traineeship 

Database which is used by Division of 

Nursing staff and not the applicants. 

Data from the tables will be used in 

the award determination and validation 

process. Additionally, the data will be 

used to ensure programmatic 

compliance, report to Congress and 

policymakers on the program 

accomplishments, and formulate and 

justify future budgets for these activities 

submitted to OMB and Congress. 

The burden estimate for this project is 

as follows: AENT increased from 1 hour 

to 1.5 hours due to the revisions of 

AENT Tables 1, 2, 3 and 4 to capture 

comprehensive data to provide for more 

detailed data analysis of the AENT 

Program. NAT burden estimate is 

increased from 1 hour to 1.5 hours in 

fiscal year 2011 due to the additional 

data collection. 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

AENT .................................................................................... 500 1 500 1.5 750 

NAT ...................................................................................... 100 1 100 1.5 150 

Total .............................................................................. 600 ........................ 600 ........................ 900 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’ 

Dated: January 14, 2010. 

Sahira Rafiullah, 

Deputy Director, Division of Policy Review 

and Coordination. 

[FR Doc. 2010–1173 Filed 1–21–10; 8:45 am] 

BILLING CODE 4165–15–P 

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 the following meetings. 

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 Institute of 

Mental Health Special Emphasis Panel, 

Translational Research Center in Behavioral 

Science. 

Date: February 19, 2010. 

Time: 12 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. (Telephone 

Conference Call.) 

Contact Person: Serena P. Chu, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd., Room 6154, MSC 9609, 

Rockville, MD 20892–9609. 301–443–0004. 

sechu@mail.nih.gov. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel, 

Identification and Characterization of 

Sensitive Periods for Neurodevelopment in 

Studies of Mental Illness. Date: February 22– 

23, 2010. Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Four Seasons Hotel DTRS 

Washington, LLC, 2800 Pennsylvania 

Avenue, NW., Washington, DC 20007. 

Contact Person: Megan Libbey, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd., Room 6148, MSC 9609, 

Rockville, MD 20852–9609. 301–402–6807. 

libbeym@mail.nih.gov. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel, 

Eating Disorders. 

Date: February 23, 2010. 

Time: 1:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. (Telephone 

Conference Call.) 

Contact Person: Serena P. Chu, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd., Room 6154, MSC 9609, 

Rockville, MD 20892–9609. 301–443–0004. 

sechu@mail.nih.gov. 

(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, 

National Institutes of Health, HHS) 


erowe on DSK5CLS3C1PROD with NOTICES