48760 Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 

appropriate advisory committee hot line/ 

phone line to learn about possible 

modifications before coming to the meeting. 

Agenda: On November 12 and 13, 2009, 

the Committee will discuss strategies and 

programs designed to communicate with the 

public about the risks and benefits of FDAregulated products so as to facilitate optimal 

use of these products. For more specific 

agenda topics, please visit the following Web 

site and scroll down to the appropriate 

advisory committee link (http:// 

www.fda.gov/AdvisoryCommittees/Calendar/ 

default.htm), or call the FDA Advisory 

Committee Information Line as detailed 

under ‘‘Contact Person’’. FDA intends to 

provide specific agenda topics at both these 

locations no later than 15 days before the 

meeting. 

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/AdvisoryCommittees/Calendar/ 

default.htm. 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 4, 2009. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m. on 

November 12, 2009, and between 

approximately 10:30 a.m. and 11:30 a.m. on 

November 13, 2009. 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 4, 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 November 

5, 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 Lee 

Zwanziger 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/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.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: September 18, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23001 Filed 9–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel. ‘‘NIAID Science Education 

Awards.’’ 

Date: October 5, 2009. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge 6700, 6700B Rockledge Drive, 

Bethesda, MD 20817 (Telephone Conference 

Call). 

Contact Person: Jay Bruce Sundstrom, PhD, 

Scientific Review Official, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, Room 

2217, 6700B Rockledge Drvie, MSC–7616, 

Bethesda, MD 20892–7616, (301) 496–2550, 

sundstromj@niaid.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: September 18, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23121 Filed 9–23–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0444] 

Schmid Laboratories, Inc. et al.; 

Proposal To Withdraw Approval of Five 

New Drug Applications; Opportunity 

for a Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity to request a hearing on the 

agency’s proposal to withdraw approval 

of five new drug applications (NDAs) 

from multiple sponsors. The basis for 

the proposal is that the sponsors have 

repeatedly failed to file required annual 

reports for these applications. 

DATES: Submit written requests for a 

hearing by October 26, 2009; submit 

data and information in support of the 

hearing request by November 23, 2009. 

ADDRESSES: Requests for a hearing, 

supporting data, and other comments 

are to be identified with Docket No. 

FDA–2009–N–0444 and submitted to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6366, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of approved applications to 

market new drugs for human use are 

required to submit annual reports to 

FDA concerning each of their approved 

applications in accordance with 

§ 314.81 (21 CFR 314.81). The holders of 

the approved applications listed in table 

1 of this document have failed to submit 

the required annual reports and have 

not responded to the agency’s request by 

certified mail for submission of the 

reports. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 48761 

TABLE 1 

Application No. Drug Applicant 

NDA 5–766 Ramses Vaginal Jelly Schmid Laboratories, Inc., Route 46 West, Little Falls, NJ 07424 

NDA 7–220 Synthetic Vitamin A (vitamin A palmitate) Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, West Point, 

PA 19486 

NDA 8–595 Immolin Vaginal Cream Jel Schmid Laboratories, Inc. 

NDA 8–612 Silicote (simethicone) Ointment Arnar-Stone Laboratories, Inc., 601 East Kensington Rd., Mount 

Prospect, IL 60056 

NDA 10–915 Q.E.D. Hairgroom (captan) A.R. Winarick, Inc., 783 Palisade Ave., Cliffside, NJ 07010 

Therefore, notice is given to the 

holders of the approved applications 

listed in table 1 of this document and to 

all other interested persons that the 

Director of the Center for Drug 

Evaluation and Research proposes to 

issue an order under section 505(e) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 355(e)) 

withdrawing approval of the 

applications and all amendments and 

supplements thereto on the ground that 

the applicants have failed to submit 

reports required under § 314.81. 

In accordance with section 505 of the 

act and part 314 (21 CFR part 314), the 

applicants are hereby provided an 

opportunity for a hearing to show why 

the applications listed previously 

should not be withdrawn and an 

opportunity to raise, for administrative 

determination, all issues relating to the 

legal status of the drug products covered 

by these applications. 

An applicant who decides to seek a 

hearing shall file the following: (1) A 

written notice of participation and 

request for a hearing (see DATES), and (2) 

the data, information, and analyses 

relied on to demonstrate that there is a 

genuine and substantial issue of fact 

that requires a hearing (see DATES). Any 

other interested person may also submit 

comments on this notice. The 

procedures and requirements governing 

this notice of opportunity for a hearing, 

notice of participation and request for a 

hearing, information and analyses to 

justify a hearing, other comments, and 

a grant or denial of a hearing are 

contained in § 314.200 and in 21 CFR 

part 12. 

The failure of an applicant to file a 

timely written notice of participation 

and request for a hearing, as required by 

§ 314.200, constitutes an election by that 

applicant not to avail itself of the 

opportunity for a hearing concerning the 

proposal to withdraw approval of the 

applications and constitutes a waiver of 

any contentions concerning the legal 

status of the drug products. FDA will 

then withdraw approval of the 

applications and the drug products may 

not thereafter lawfully be marketed, and 

FDA will begin appropriate regulatory 

action to remove the products from the 

market. Any new drug product 

marketed without an approved new 

drug application is subject to regulatory 

action at any time. 

A request for a hearing may not rest 

upon mere allegations or denials, but 

must present specific facts showing that 

there is a genuine and substantial issue 

of fact that requires a hearing. Reports 

submitted to remedy the deficiencies 

must be complete in all respects in 

accordance with § 314.81. If the 

submission is not complete or if a 

request for a hearing is not made in the 

required format or with the required 

reports, the Commissioner of Food and 

Drugs will enter summary judgment 

against the person who requests the 

hearing, making findings and 

conclusions, and denying a hearing. 

All submissions under this notice of 

opportunity for a hearing must be filed 

in four copies. Except for data and 

information prohibited from public 

disclosure under 21 U.S.C. 331(j) or 18 

U.S.C. 1905, the submissions may be 

seen in the Division of Dockets 

Management (see ADDRESSES) between 9 

a.m. and 4 p.m., Monday through 

Friday, or on the Internet at http:// 

www.regulations.gov. 

This notice is issued under the 

Federal Food, Drug, and Cosmetic Act 

(sec. 505 (21 U.S.C. 355)) and under 

authority delegated to the Director, 

Center for Drug Evaluation and 

Research, by the Commissioner of Food 

and Drugs. 

Dated: September 9, 2009. 

Douglas C. Throckmorton, 

Deputy Director, Center for Drug Evaluation 

and Research. 

[FR Doc. E9–23005 Filed 9–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0383] 

Request for Notification From Industry 

Organizations Interested in 

Participating in the Selection Process 

for a Nonvoting Industry 

Representative on the Tobacco 

Products Scientific Advisory 

Committee and Request for 

Nominations for Nonvoting Industry 

Representatives on the Tobacco 

Products Scientific Advisory 

Committee; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of the Request for Notification 

From Industry Organizations Interested 

in Participating in the Selection Process 

for a Nonvoting Industry Representative 

on the Tobacco Products Scientific 

Advisory Committee and Request for 

Nominations for Nonvoting Industry 

Representatives on the Tobacco 

Products Scientific Advisory 

Committee. This meeting was 

announced in the Federal Register of 

August 26, 2009 (74 FR 43140). The 

amendment is being made to reflect 

changes in the DATES, ADDRESSES, and 

Selection Procedure portions of the 

document. There are no other changes. 

FOR FURTHER INFORMATION CONTACT: 

Teresa L. Hays, Food and Drug 

Administration, Center for Tobacco 

Products, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 301–796– 

3369, FAX: 301–595–7946, e-mail: 

Teresa.Hays@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 26, 2009, 

FDA announced a Request for 

Notification From Industry 

Organizations Interested in Participating 


srobinson on DSKHWCL6B1PROD with NOTICES