Federal Register / Vol. 74, No. 93 / Friday, May 15, 2009 / Notices 22941 

Subcommittee topics. The first panel will 

focus on Primary Care Workforce. The 

confirmed speakers are Dr. Bruce Vogt, Chair 

of Family Medicine, University of South 

Dakota; Dr. Charles Hart, CEO of Regional 

Health System; and Josie Peterson, South 

Dakota PCO Director. The second panel is 

Home-Based Care Options for Seniors. The 

confirmed speakers are Deb Bowman, 

Committee Member and Secretary of the 

South Dakota Department of Social Services; 

and Senator Jean Hunhoff, head of home care 

services at Yankton, South Dakota, and 

member of the task force on Meeting the 

Continuum of Care Needs of the Elderly in 

South Dakota. The final panel of the day is 

Health Care Provider Integration. The 

confirmed speakers are Tom Dean, MedPAC 

Member; Scot Graff, Community Healthcare 

Association of the Dakotas; and Matt 

Michaels, Health Care Attorney. After the 

panel discussions, the Committee Chair will 

give an overview of the site visits. The 

Tuesday meeting will close at 4:45 p.m. 

Wednesday morning, at 8:45 a.m., the 

Committee will break into Subcommittees 

and depart to the site visits. The Primary 

Care Workforce Subcommittee will visit 

Phillip Health Services in Philip, South 

Dakota. The Home-Based Care Options for 

Seniors Subcommittee will visit Regional 

Health Hospice Center in Rapid City, South 

Dakota. The Health Care Provider Integration 

Subcommittee will visit Custer Regional 

Hospital in Custer, South Dakota. 

Transportation to the site visits will not be 

provided to the public. The Subcommittees 

will return to Rapid City, South Dakota at 3 

p.m. The Wednesday meeting will close at 3 

p.m. 

The final session will be convened on 

Thursday morning at 8:45 a.m. The meeting 

will open with a review of the Subcommittee 

site visits. The staff of the Office of Rural 

Health Policy will provide an update on the 

Department of Health and Human Services. 

The Committee will draft a letter to the 

Secretary or Designee and discuss the 

September meeting. 

For Further Information Contact: Anyone 

requiring information regarding the 

Committee should contact Jennifer Chang, 

MPH, Executive Secretary, National Advisory 

Committee on Rural Health and Human 

Services, Health Resources and Services 

Administration, Parklawn Building, Room 

9A–55, 5600 Fishers Lane, Rockville, MD 

20857, Telephone (301) 443–0835, Fax (301) 

443–2803. 

Persons interested in attending any portion 

of the meeting should contact Michele Pray 

Gibson, Office of Rural Health Policy 

(ORHP), Telephone (301) 443–0835. The 

Committee meeting agenda will be posted on 

ORHP’s Web site http:// 

www.ruralhealth.hrsa.gov. 

Dated: April 11, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–11441 Filed 5–14–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Pediatric 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: Pediatric 

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 Tuesday, June 23, 2009, from 

8:30 a.m. to 5 p.m. 

Location: Hilton Washington DC/ 

Rockville Executive Meeting Center, 

Plaza Ballroom, 1750 Rockville Pike, 

Rockville, MD 20852. 

Contact Person: Carlos Pen ̃ a, Office of 

Science and Health Coordination, Office 

of the Commissioner (HF–33), Food and 

Drug Administration, 5600 Fishers Lane 

(for express delivery, rm. 14B–08), 

Rockville, MD 20857, 301–827–3340, or 

by e-mail: carlos.pen ̃ a@fda.hhs.gov or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

8732310001. 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: On June 23, 2009, the 

Pediatric Advisory Committee will 

review and discuss reports by the 

agency, as mandated by the Best 

Pharmaceuticals for Children Act and 

the Pediatric Research Equity Act, for 

ALVESCO (ciclesonide), ANDROGEL 

(testosterone), ASMANEX (mometasone 

furoate), COMBIGAN (brimonidine/ 

timolol), DEPAKOTE (divalproex 

sodium), DERMA–SMOOTHE F/S 

(fluocinolone acetate), DIOVAN 

(valsartan), HEPSERA (adefovir 

dipivoxil), INSPRA (eplerenone), 

MOXATAG (amoxicillin), OMNARIS 

(ciclesonide), and ZOMETA (zoledronic 

acid). 

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 is 

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

dockets/ac/acmenu.htm, click on the 

year 2009 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 June 9, 2009. 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 June 1, 2009. Time allotted for 

each presentation may be limited. If the 

number of registrants 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 June 2, 2009. 

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 Carlos Pen ̃ a 

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). 

22942 Federal Register / Vol. 74, No. 93 / Friday, May 15, 2009 / Notices 

Dated: May 8, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–11317 Filed 5–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0191] 

Request for Nominations for Voting 

Consumer Representative Members on 

Public Advisory Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting consumer 

representatives to serve on the Food 

Advisory Committee. This advisory 

committee is under the purview of the 

Center for Food Safety and Applied 

Nutrition (CFSAN). 

FDA has a special interest in ensuring 

that women, minority groups, and 

individuals with disabilities are 

adequately represented on its advisory 

committees and, therefore, encourages 

nominations of qualified candidates 

from these groups. 

DATES: Nominations will be accepted for 

those voting consumer representative 

vacancies that will occur on June 30, 

2010. Nominations received before July 

14, 2009, will be considered for June 30, 

2010, vacancies. Nominations received 

after July 14, 2009, will be accepted for 

vacancies occurring after June 30, 2010. 

ADDRESSES: All nominations for 

membership should be sent 

electronically to CV@OC.FDA.GOV, or 

by mail to Advisory Committee 

Oversight and Management Staff (HF– 

4), 5600 Fishers Lane, rm. 15A–12, 

Rockville, MD 20857. Information about 

becoming a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s Web site at http:// 

www.fda.gov/oc/advisory/default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Carolyn Jeletic, Center for Food Safety 

and Applied Nutrition (HFS–024), 5100 

Paint Branch Pkwy., College Park, MD 

20740, 301–436–1913, FAX: 301–436– 

2637, e-mail: 

Carolyn.Jeletic@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

consumer members on the following 

CFSAN committee: 

I. Function 

Food Advisory Committee 

The Committee provides advice 

primarily to Commissioner of Food and 

Drugs and other appropriate officials, on 

emerging food safety, food science, 

nutrition, and other food-related health 

issues that FDA considers of primary 

importance for its food and cosmetics 

programs. The Committee may be 

charged with reviewing and evaluating 

available data and making 

recommendations on matters such as 

those relating to the following topics: (1) 

Broad scientific and technical food or 

cosmetic related issues, (2) the safety of 

new foods and food ingredients, (3) 

labeling of foods and cosmetics, (4) 

nutrient needs and nutritional 

adequacy, and (5) safe exposure limits 

for food contaminants. The Committee 

may also be asked to provide advice and 

make recommendations on ways of 

communicating to the public the 

potential risks associated with these 

issues and on approaches that might be 

considered for addressing the issues. 

II. Criteria for Members 

Persons who are nominated for 

membership on the committees as 

consumer representatives must meet the 

following criteria: (1) Demonstrate ties 

to consumer and community-based 

organizations, (2) be able to analyze 

scientific and technical data, (3) 

understand research design, and (4) 

discuss benefits and risks. The 

consumer representative must be able to 

represent the consumer perspective on 

issues and actions before the advisory 

committee; serve as a liaison between 

the committee and interested 

consumers, associations, coalitions, and 

consumer organizations; and facilitate 

dialogue with the advisory committees 

on scientific issues that affect 

consumers. 

III. Selection Procedures 

The selection of members 

representing consumer interests is 

conducted through procedures that 

include the use of organizations 

representing the public interest and 

consumer advocacy groups. The 

organizations have the responsibility of 

recommending candidates of the 

agency’s selection. 

IV. Nomination Procedures 

All nominations must include a cover 

letter, a curriculum vitae or resume (that 

includes the nominee’s office address, 

telephone number, and e-mail address), 

and a list of consumer or communitybased organizations for which the 

candidate can demonstrate active 

participation. Nominations will specify 

the advisory committee for which the 

nominee is recommended. Nominations 

will include confirmation that the 

nominee is aware of the nomination. 

Any interested person or organization 

may nominate one or more qualified 

persons for membership on one or more 

of the advisory committees to represent 

consumer interests. Self-nominations 

are also accepted. FDA will ask the 

potential candidates to provide detailed 

information concerning such matters as 

financial holdings, employment, and 

research grants and/or contracts to 

permit evaluation of possible sources of 

a conflict of interest. The nomination 

should specify the committee of 

interest. The term of office is up to 4 

years, depending on the appointment 

date. This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: May 7, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–11319 Filed 5–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0209] 

Small Entity Compliance Guide: Health 

Claims; Calcium and Osteoporosis, 

and Calcium, Vitamin D, and 

Osteoporosis; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Food Labeling: Health Claims; 

Calcium and Osteoporosis, and 

Calcium, Vitamin D, and Osteoporosis— 

Small Entity Compliance Guide.’’ The 

small entity compliance guide (SECG) is 

being issued for a final rule published 

in the Federal Register of September 29, 

2008, as corrected on November 12, 

2008, and it is intended to set forth in 

plain language the legal requirements of 

the regulation and to help small 

businesses understand the regulation. 

DATES: Submit written or electronic 

comments on the SECG at any time. 

ADDRESSES: Submit written comments 

on the SECG to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the SECG to