Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 76007 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–6162. Written comments and 

recommendations for the proposed 

information collections must be directed 

to the OS Paperwork Clearance Officer 

at the above e-mail address within 30 

days. 

Proposed Project: Evaluation of 

SAMHSA Primary Care Behavioral 

Health Integration Grant Program. 

Emergency Information Collection 

Clearance Request—OMB No. 0990– 

NEW-Assistant Secretary for Planning 

and Evaluation . 

Abstract: The Assistant Secretary for 

Planning and Evaluation (ASPE) and the 

Substance Abuse and Mental Health 

Administration are funding an 

independent evaluation of the 

Substance Abuse and Mental Health 

Administration/Center for Mental 

Health Services’ (SAMHSA/CMHS) 

Primary Care Behavioral Health 

Integration (PBHCI) grant program. 

Four-year PBHCI grants were awarded 

to thirteen grantees on October 1, 2009. 

A second group of nine grants and a 

third group of up to 38 additional grants 

will be awarded prior to October 1, 

2010. The purpose of the PBHCI grants 

is to improve the overall wellness and 

physical health status of people with 

serious mental illnesses (SMI), 

including individuals with co-occurring 

substance use disorders, by supporting 

communities to coordinate and integrate 

primary care services into publicly 

funded community mental health and 

other community-based behavioral 

health settings. The information 

collected through the evaluation will 

assist SAMHSA in assessing whether 

integrated primary care services 

produce improvements in the physical 

and mental health of the SMI 

population receiving services from 

community-based behavioral health 

agencies. 

ESTIMATED ANNUALIZED BURDEN TABLE

Form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Total annual 

burden 

(hours) 

Client exam/survey (control group, 1st cohort) ............................................. 900 1 45/60 675 

Client service report ....................................................................................... 63 4 8 .00 2,016 

Quarterly reports ............................................................................................ 60 4 2 .00 480 

New TRAC indicators .................................................................................... 60 200 0 .08 960 

Leadership .............................................................................................. 9 1 2 .00 18 

PH Providers .......................................................................................... 9 1 1 .50 14 

MH Providers .......................................................................................... 9 1 1 .00 9 

Care Coordinators .................................................................................. 6 1 1 .50 9 

Site visit interview (1st cohort, control sites) ................................................. 15 1 2 .00 30 

Total ........................................................................................................ 1,131 ........................ .......................... 4,211 

Seleda M. Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2010–30516 Filed 12–6–10; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–11–0263] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. 

Alternatively, to obtain a copy of the 

data collection plans and instrument, 

call 404–639–5960 and send comments 

to Carol Walker, Acting CDC Reports 

Clearance Officer, 1600 Clifton Road 

NE., MS–D74, Atlanta, Georgia 30333; 

comments may also be sent by e-mail to 

omb@cdc.gov. 

Comments are invited on (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have a 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of information technology. Written 

comments should be received within 60 

days of this notice. 

Proposed Project 

Requirements for a Special Permit to 

Import Cynomolgus, African Green, or 

Rhesus Monkeys into the United States 

(OMB Control No. 0920–0263 exp. 

6/30/2011)—Extension—National 

Center for Emerging and Zoonotic 

Infectious Diseases, (NCEZID), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

CDC is requesting OMB approval to 

continue its data collection, 

‘‘Requirements for a Special Permit to 

Import Cynomolgus, African Green, or 

Rhesus Monkeys into the United States’’, 

for another three years. This data 

collection is currently approved under 

OMB Control No. 0920–0263. There are 

no revisions proposed to the currently 

approved information collection 

request. 

A registered importer must request a 

special permit to import Cynomolgus, 

African Green, or Rhesus monkeys. To 

receive a special permit to import 

nonhuman primates, the importer must 

submit a written plan to the Director of 

CDC which specifies steps that will be 

taken to prevent exposure of persons 

and animals during the entire 

importation and quarantine process for 

the arriving nonhuman primates. 

Under the special permit 

arrangement, registered importers must 

submit a plan to CDC for importation 

and quarantine if they wish to import 

the specific monkeys covered. The plan 

must address disease prevention 

procedures to be carried out in every 

step of the chain of custody of such 


emcdonald on DSK2BSOYB1PROD with NOTICES
76008 Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 

monkeys, from embarkation in the 

country of origin to release from 

quarantine. Information such as species, 

origin and intended use for monkeys, 

transit information, isolation and 

quarantine procedures, and procedures 

for testing of quarantined animals is 

necessary for CDC to make public health 

decisions. This information enables 

CDC to evaluate compliance with the 

standards and to determine whether the 

measures being taken are adequate to 

prevent exposure of persons and 

animals during importation. CDC will 

monitor at least 2 shipments to be 

assured that the provisions of a special 

permit plan are being followed by a new 

permit holder. CDC will assure that 

adequate disease control practices are 

being used by new permit holders 

before the special permit is extended to 

cover the receipt of additional 

shipments under the same plan for a 

period of 180 days, and may be renewed 

upon request. This extension eliminates 

the burden on importers to repeatedly 

report identical information, requiring 

submission only of specific shipment 

itineraries and information on changes 

to the plan which require approval. 

Respondents are businesses or not-forprofit organizations that import 

nonhuman primates. The burden 

represents full disclosure of information 

and itinerary/change information, 

respectively. There are no costs to 

respondents except for their time to 

complete the requisition process. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Instrument Respondents Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

Request for Special Permit .............. Businesses (limited permit) ............. 5 2 30/60 5 

Request for Special Permit .............. Businesses (extended permit) ......... 1 3 10/60 0 .5 

Request for Special Permit .............. Organizations (limited permit) ......... 3 2 30/60 3 

Request for Special Permit .............. Organizations (extended permit) ..... 12 2 10/60 4 

Total .......................................... .......................................................... ........................ ........................ ........................ 12 .5 

Dated: November 30, 2010. 

Carol Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–30618 Filed 12–6–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0606] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Additional Listing 

Information for Medical Device 

Registration and Listing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting and recordkeeping burden 

requirements associated with additional 

listing information for medical device 

registration and listing by nonelectronic means. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 7, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Additional Listing Information for 

Medical Device Registration and Listing 

(OMB Control Number 0910–0387)— 

Extension 

The Food and Drug Administration 

Amendments Act of 2007 (FDAAA), 

enacted September 27, 2007, requires 

that device establishment registrations 

and listings under 21 U.S.C. 360(p) 

(including the submission of updated 

information) be submitted to the 

Secretary of Health and Human Services 

(the Secretary) by electronic means, 


emcdonald on DSK2BSOYB1PROD with NOTICES