Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices 42675 

U.S.C. 375(b)) authorizes FDA to 

disseminate information concerning 

imminent danger to public health by 

any regulated product. The Center for 

Devices and Radiological Health 

(CDRH), communicates these risks to 

user communities through two 

publications: (1) The Public Health 

Notification (PHN) and (2) the 

Preliminary Public Health Notification 

(PPHN). The PHN is published when 

CDRH has information or a message to 

convey to health care practitioners that 

they would want to know in order to 

make informed clinical decisions about 

the use of a device or device type, and 

that information may not be readily 

available to the affected target audience 

in the health care community. CDRH 

can make recommendations that will 

help the health care practitioner 

mitigate or avoid the risk. 

The PPHN is also published when 

CDRH has information to convey to 

health care practitioners that they 

would want to know in order to make 

informed clinical decisions about the 

use of a device or device type. However, 

two additional conditions exist that 

make the use of this type of notification 

preferable: (1) CDRH’s understanding of 

the problem, its cause(s), and the scope 

of the risk that is still evolving, so that 

in order to minimize the risk, the center 

believes that health care practitioners 

needs the information they can provide, 

however incomplete, as soon as possible 

and (2) the problem is actively being 

investigated by the center, private 

industry, another agency or some other 

reliable entity, so that the center expects 

to be able to update the PPHN when 

definitive new information becomes 

available. Notifications are sent to 

organizations affected by risks discussed 

in the notification, such as hospitals, 

nursing homes, hospices, home health 

care agencies, retail pharmacies, and 

other health care providers. Through a 

process for identifying and addressing 

postmarket safety issues related to 

regulated products, CDRH determines 

when to publish notifications. 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)), authorizes FDA to conduct 

research relating to health information. 

FDA seeks to evaluate the clarity, 

timeliness and impact of safety alerts 

and public health advisories by 

surveying a sample of recipients. 

Subjects will receive a questionnaire to 

be completed and returned to FDA. The 

information to be collected will address 

how clearly notifications for reducing 

risks are explained, the timeliness of the 

information and whether the reader has 

taken any action to eliminate or reduce 

risk as a result of the information in the 

alert. Subjects will also be asked 

whether they wish to receive future 

notifications electronically, as well as 

how the PHN program might be 

improved. 

The information collected will be 

used to shape FDA’s editorial policy for 

the PHN and PPHN. Understanding how 

target audiences view these publications 

will aid in deciding what changes 

should be considered in their content 

and format, and method of 

dissemination. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

PHS Act No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Section 1701(a)(4) 308 3 924 .17 157 

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

Based on the history of the PHN 

program, it is estimated that an average 

of three collections will be conducted a 

year. The total burden of response time 

is estimated at 10 minutes per survey. 

This was derived by CDRH staff 

completing the survey and through 

discussions with the contacts in trade 

organizations. 

Dated: August 17, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20247 Filed 8–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Refugee Unaccompanied Minor 

Placement Report & Minor Progress 

Reports; ORR–3 and ORR–4. 

OMB No.: 0970–0034. 

Description: The two reports collect 

information necessary to administer the 

Unaccompanied Refugee Minor (URM) 

program. The ORR–3 (Placement 

Report) is submitted to the Office of 

Refugee Resettlement (ORR) by the State 

agency at initial placement and 

whenever there is a change in the 

child’s status, including termination 

from the program. The ORR–4 (Progress 

Report) is submitted annually and 

records the child’s progress toward the 

goals listed in the child’s case plan. 

Respondents: State governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

ORR–3 ............................................................................................................................. 15 63 0.25 236.25 

ORR–4 ............................................................................................................................. 15 63 0.30 283.50 

Estimated Total Annual Burden 

Hours: 519.75 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 


erowe on DSK5CLS3C1PROD with NOTICES
42676 Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments 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 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

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 automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: August 18, 2009. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. E9–20175 Filed 8–21–09; 8:45 am] 

BILLING CODE 4184–01–P 

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: 

Proposed Project: HRSA/Bureau of 

Primary Health Care Capital 

Improvement Program Application 

Electronic Health Records (EHR) 

Readiness Checklist (OMB No. 0915– 

0325)—Extension 

The American Recovery and 

Reinvestment Act (ARRA) provides $1.5 

billion in grants to support 

‘‘construction, renovation and 

equipment’’, and ‘‘the acquisition of 

health information technology systems, 

for health centers including health 

center controlled networks receiving 

operating grants under section 330’’ of 

the Public Health Service (PHS) Act, as 

amended (42 U.S.C. 254b). HRSA is 

requesting extension of the approval of 

the Electronic Health Records (EHR) 

Readiness Checklist portion of the 

application where applicants must 

provide information to demonstrate 

readiness for electronic health records if 

they propose to use funds for electronic 

health record (EHR) related purchases. 

Of the $1.5 billion, HRSA will award 

approximately $850 million, through 

limited competition grants, for one-time 

Capital Improvement Program (CIP) 

grant funding in fiscal year (FY) 2009 to 

support existing section 330 funded 

health centers. Funding under this 

opportunity will address pressing 

capital improvement needs in health 

centers, such as construction, repair, 

renovation, and equipment purchases, 

including health information technology 

systems. Applicants must provide 

information using the EHR Readiness 

Checklist that demonstrates 

comprehensive planning and readiness 

for implementing EHRs. 

The estimated annual burden is as 

follows: 

Form Number of 

respondents 

Responses per 

respondent Total responses Hours per response 

Total burden 

hours 

EHR Readiness Checklist ................................ 568 1 568 .25 142 

Total .......................................................... 568 ............................ 568 ............................ 142 

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: August 18, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–20306 Filed 8–21–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0345] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Internet Survey on 

Barriers to Food Label Use 

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, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the Internet Survey on Barriers to Food 

Label Use. 

DATES: Submit written or electronic 

comments on the collection of 

information by October 23, 2009. 

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 (HFA–710), Food and Drug 


erowe on DSK5CLS3C1PROD with NOTICES