Federal Register / Vol. 72, No. 203 / Monday, October 22, 2007 / Notices 59535 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: October 15, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention (CDC). 

[FR Doc. E7–20696 Filed 10–19–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel: Centers for Disease 

Control and Prevention (CDC) Grants 

for Public Health Research 

Dissertation, Program Announcement 

(PA) PAR 07–231, Panel A 

Correction: This notice was published 

in the Federal Register on October 10, 

2007, Volume 72, Number 195, page 

57582. The time and date should read 

as follows: 

Time and Date: 8:30 a.m.–5 p.m., 

November 15, 2007 (Closed). 

Contact Person for More Information: 

Juliana Cyril, PhD, MPH, Scientific 

Review Administrator, Office of the 

Chief Science Officer, CDC, 1600 Clifton 

Road, NE., Mailstop D 72, Atlanta, GA 

30333. Telephone (404) 639–4896. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: October 15, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–20688 Filed 10–19–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Healthcare Infection Control Practices 

Advisory Committee (HICPAC) 

Correction: This notice was published 

in the Federal Register on October 11, 

2007, Volume 72, Number 196, page 

57947–57948. The Place should read as 

follows: 

Place: Department of Health and 

Human Services Building, 395 E Street, 

SW., Suite 9100, Washington, DC 20201. 

Contact Person for More Information: 

Angela B. Scott, Committee 

Management Specialist, HICPAC, 

Division of Healthcare Quality 

Promotion, NCPDCID, CDC, 1600 

Clifton Road, N.E., Mailstop A 45, 

Atlanta, GA 30333. Telephone (404) 

639–1526. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: October 15, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–20699 Filed 10–19–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request; Proposed 

Project 

Title: Compassion Capital Fund 

Impact Evaluation Process Study. 

OMB No.: New Collection. 

Description: The information 

collection activity proposed under this 

notice will obtain information about 

intermediary grantee agencies providing 

capacity building assistance to faithbased and community organizations 

under the Compassion Capital Fund 

(CCF) Demonstration program. The 

information gathered under this data 

collection activity will be used to 

describe the approach and methods 

used by intermediaries to provide the 

services that are being evaluated in the 

CCF impact evaluation. Information 

collection will be through informal 

discussions and observations on-site at 

the organizations, using uniform 

protocols. 

Respondents: Directors and staff 

providing technical assistance and 

related services to faith-based and 

community organizations and directors 

and staff in faith-based and community 

organizations that have received 

capacity building assistance. 

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Intermediary Protocol for Executive Director ................................................... 10 1 3 30 

Intermediary Protocol for Key Staff ................................................................. 30 1 1 30 

Faith-based or Community Organization Protocol for Executive Director ...... 30 1 2 60 

Faith-based or Community Organization Protocol for Key Staff ..................... 60 1 1 60 

Estimated Total Annual Burden 

Hours: 180. 

In compliance with the requirements 

of Section 3506(c)(1)(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 

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 


ebenthall on PRODPC61 with NOTICES
59536 Federal Register / Vol. 72, No. 203 / Monday, October 22, 2007 / Notices 

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. Consideration will be 

given to comments and suggestions 

submitted within 60 days of this 

publication. 

Dated: October 10, 2007. 

Brendan C. Kelly, 

Reports Clearance Officer. 

[FR Doc. 07–5176 Filed 10–19–07; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0133] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Experimental Evaluation of Variations 

in Content and Format of the Brief 

Summary in Direct-to-Consumer Print 

Advertisements for Prescription Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Experimental Evaluation of Variations 

in Content and Format of the Brief 

Summary in Direct-to-Consumer (DTC) 

Print Advertisements for Prescription 

Drugs’’ has been approved by the Office 

of Management and Budget (OMB) 

under the Paperwork Reduction Act of 

1995. 

FOR FURTHER INFORMATION CONTACT: 

Karen L. Nelson, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4816. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 14, 2007 (72 

FR 11889), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0611. The 

approval expires on October 31, 2010. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.fda.gov/ 

ohrms/dockets. 

Dated: October 12, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–20756 Filed 10–19–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0114] 

Electronic Distribution of Prescribing 

Information for Prescription Drug 

Products; Reopening of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening to 

December 6, 2007 the comment period 

for the notice that published in the 

Federal Register of April 2, 2007 (72 FR 

15701); this notice was related to the 

public hearing of April 27, 2007, 

concerning the electronic distribution of 

FDA-approved prescribing information 

currently contained in the package 

insert (PI) for prescription drug and 

biological products. FDA is reopening 

the comment period for the sole purpose 

of inviting interested persons to submit 

comments on the concept of electronic 

distribution of FDA-approved 

prescribing information currently 

contained in the PI for prescription 

animal drug products. 

DATES: Submit written or electronic 

comments by December 6, 2007. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to either http:// 

www.fda.gov/dockets/ecomments or 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Erik 

Mettler, Office of Policy (HF–11), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3360, Erik.Mettler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register notice of April 

2, 2007 (72 FR 15701), FDA published 

a notice of public hearing concerning 

the concept of the electronic 

distribution of PIs for human 

prescription drugs and biological 

products and solicited relevant 

information and comments on this 

concept. The purpose was to garner 

views and information on the feasibility 

of establishing an efficient process for 

industry to electronically distribute 

prescribing information to dispensers. 

The PIs with prescribing information 

accompany prescription human drugs to 

meet the requirement that ‘‘labeling on 

or within the package from which the 

drug is to be dispensed bears adequate 

information for its use * * *’’ (21 CFR 

201.100(c)(1)). For additional 

information, see the April 2, 2007, 

notice ( 72 FR 15701). 

Currently, the PI contains the 

prescribing information for the safe and 

effective use of the product in the form 

of a paper leaflet. Although the 

information in the PI is a valuable 

resource, it is often not readily 

accessible when a healthcare provider 

who has not physically received the 

drug makes a treatment decision or 

discusses treatments with a patient. 

Additionally, the PI may not contain the 

most current information, because the PI 

accompanying the drug’s distribution 

may have been printed and distributed 

prior to more recent labeling changes. 

Accordingly, with technological 

advances in the electronic transmission 

of information, we are considering how 

prescribing information could be more 

effectively disseminated. 

FDA is reopening the comment period 

for the sole purpose of inviting 

interested persons to submit comments 

addressing a number of questions 

regarding the current use of package 

inserts for animal drug products and 

those logistical issues associated with 

electronic distribution of such 

prescribing information for animal drug 

products. The previous request for 

comments was limited to human drugs 

and biologics. As with prescription 

human drugs, the PIs with prescribing 

information accompany prescription 

animal drugs to meet the requirement 

that ‘‘labeling on or within the package 

from which the drug is to be dispensed 

bears adequate information for its use 

***’’ (21 CFR 201.105(c)(1)). FDA 

approves the prescribing information as 

part of both human and animal drug 

labeling in the drug application. The 

request for comment is to gain a better 

understanding of how PIs for animal 

drugs are currently used by healthcare 

entities as we consider new approaches 

for the dissemination of labeling 

information. 

II. Issues for Discussion 

FDA is specifically interested in 

receiving comments on the following 

questions and any other pertinent 


ebenthall on PRODPC61 with NOTICES