Federal Register / Vol. 72, No. 205 / Wednesday, October 24, 2007 / Notices 60377 

Secretary of Health and Human Services 

will be released for public comment in 

early November. The Committee will 

provide an extended period of time 

during the November meeting for 

members of the public to provide their 

perspectives on the oversight issues and 

comments on the Committee’s draft 

report and recommendations. The 

Committee will also be briefed about an 

international analysis of oversight 

systems for genetic testing with a focus 

on the U.S. system. 

As always, the Committee welcomes 

hearing from anyone wishing to provide 

public comment on any issue related to 

genetics, health and society. Individuals 

who would like to provide public 

comment should notify the SACGHS 

Executive Secretary, Ms. Sarah Carr, by 

telephone at 301–496–9838 or e-mail at 

carrs@od.nih.gov. The SACGHS office is 

located at 6705 Rockledge Drive, Suite 

750, Bethesda, MD 20892. Anyone 

planning to attend the meeting who is 

in need of special assistance, such as 

sign language interpretation or other 

reasonable accommodations, is also 

asked to contact the Executive 

Secretary. 

Under authority of 42 U.S.C. 217a, 

Section 222 of the Public Health Service 

Act, as amended, the Department of 

Health and Human Services established 

SACGHS to serve as a public forum for 

deliberations on the broad range of 

human health and societal issues raised 

by the development and use of genetic 

and genomic technologies and, as 

warranted, to provide advice on these 

issues. The draft meeting agenda and 

other information about SACGHS, 

including information about access to 

the Web cast, will be available at the 

following Web site: http:// 

www4.od.nih.gov/oba/sacghs.htm 

Dated: October 17, 2007. 

Jennifer Spaeth, 

Director, NIH Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–5239 Filed 10–23–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007P–0047] 

Nonprescription Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Nonprescription 

Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on December 14, 2007, from 8 a.m. 

to 5 p.m. 

Addresses: Electronic comments 

should be submitted to http:// 

www.fda.gov/dockets/ecomments. 

Select ‘‘2007P–0047—Amend the 

Dosage of Oral Phenylephrine Listed in 

the Final Monograph on Oral 

Decongestants,’’ and follow the prompts 

to submit your statement. Written 

comments should be submitted to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852, by close of business on 

December 30, 2007. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589–

5200. 

Contact Person; Diem-Kieu Ngo, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093), Rockville, MD 20857, 301–827–

7001, FAX: 301–827–6776, e-mail: 

Diem.Ngo@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301) 443–0572 in the 

Washington, DC area), code 

3014512541. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The committee will discuss 

the safety and effectiveness of 

phenylephrine hydrochloride and 

phenylephrine bitartrate as over-thecounter (OTC) oral nasal decongestants. 

The discussion at the meeting will 

address a citizen petition submitted to 

FDA on February 1, 2007 (Docket No. 

2007P–0047/CP1), which asserts that 

the available data do not support the 

adult and pediatric doses of 

phenylephrine hydrochloride and 

phenylephrine bitartrate that are 

generally recognized as safe and 

effective in the OTC drug monograph for 

Cold, Cough, Allergy, Bronchodilator, 

and Antiasthmatic Drug Products 

(CCABADP) in 21 CFR part 341. The 

meeting will focus on the review of 

existing safety and efficacy data and the 

petitioner’s request that the CCABADP 

monograph be amended to increase the 

adult dose of phenylephrine 

hydrochloride from 10 to 25 milligrams 

(mg) and that of phenylephrine 

bitartrate from 15.6 to 40 mg. 

Additional information was submitted 

to the docket for OTC Nasal 

Decongestants (Docket No. 1976N–

0052N; submissions EMC140, C251, 

C253 and Supplement 13) and is related 

to the petition or the petitioner’s 

publications. These submissions were 

submitted to the OTC Nasal 

Decongestant docket and have been 

cross-referenced and linked to Docket 

No. 2007P–0047. The petition and other 

relevant submissions can be found at 

the following Web site: http:// 

www.fda.gov/ohrms/dockets/dockets/ 

07p0047/07p0047.htm. 

Other information in Docket No. 

1976N–0052N may be considered. For 

example, see comments 10 and 11 of the 

Tentative Final Monograph for OTC 

Nasal Decongestants, published in the 

Federal Register of January 15, 1985 (50 

FR 2220 at 2226). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material will 

be available at http://www.fda.gov/ 

ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before November 30, 2007. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before November 22, 2007. Time 

allotted for each presentation may be 

limited. If the number of registrants 


yshivers on PROD1PC62 with NOTICES
60378 Federal Register / Vol. 72, No. 205 / Wednesday, October 24, 2007 / Notices 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

November 23, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Diem-Kieu 

Ngo at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 18, 2007. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. 07–5249 Filed 10–23–07; 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, 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: Office of Health 

Information Technology, Health Center 

Controlled Networks Progress 

Reports—New 

The Office of Health Information 

Technology (OHIT), Division of State 

and Community Assistance (DSCA), 

plans to collect network outcome 

measures, conduct evaluation of those 

measures, and create an electronic 

reporting system for the following new 

2007 grant opportunities: Health 

Information Technology Planning 

Grants, Electronic Health Record 

Implementation Health Center 

Controlled Networks (HCCN), Health 

Information Technology Innovations for 

Health Center Controlled Networks, and 

High Impact Electronic Health Records 

Implementation for Health Center 

Controlled Networks and Large Multi 

Site Health Centers. In order to help 

carry out its mission, DSCA has created 

a set of performance measures that 

grantees will use to evaluate the 

effectiveness of their service programs 

and monitor their progress through the 

use of performance reporting data. 

OHIT has developed an electronic 

performance measurement reporting 

instrument with HRSA’s Office of 

Information Technology. The 

instrument will accomplish the 

following goals: monitor improved 

access to needed services, evaluate the 

productivity and efficiency of the 

networks, and monitor patient outcome 

measures. Grantees will submit their 

Progress Reports in a mid-year report 

and an accumulative annual progress 

report each fiscal year of the grant. 

The estimates of burden are as 

follows: 

Form 

Estimated 

number of 

respondents 

Responses per 

respondent 

Total 

responses 

Hours 

per response 

Total burden 

hours 

HCCN Progress Reports ................................. 46 2 92 6 hrs 552 

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: October 18, 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–20939 Filed 10–23–07; 8:45 am] 

BILLING CODE 4165–15–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, call the HRSA Reports 

Clearance Office on 301–443–1129. 

The following request has been 

submitted to the OMB for review under 

the Paperwork Reduction Act of 1995: 

Proposed Project: The Nursing 

Education Loan Repayment Program 

Application (OMB No. 0915–0140)—

Revision 

This is a request for revision of the 

Nursing Education Loan Repayment 

Program (NELRP) application and 

participant monitoring forms. The 

NELRP was originally authorized by 42 

U.S.C. 297b(h) (section 836(h) of the 

Public Health Service Act) as amended 

by Public Law 100–607, November 4, 

1988. The NELRP is currently 

authorized by 42 U.S.C. 297n (section 

846 of the Public Health Service Act) as 

amended by Public Law 107–205, 

August 1, 2002. 

Under the NELRP, registered nurses 

are offered the opportunity to enter into 

a contractual agreement with the 

Secretary to receive loan repayment for 

up to 85 percent of their qualifying 

educational loan balance as follows: 30 


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