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should not be withdrawn and an 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
48762 Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 

in the Selection Process for a Nonvoting 

Industry Representative on the Tobacco 

Products Scientific Advisory Committee 

and Request for Nominations for a 

Nonvoting Industry Representatives on 

the Tobacco Products Scientific 

Advisory Committee of the Tobacco 

Products Scientific Advisory 

Committee. 

On page 43140, in the third column, 

the DATES portion of the document is 

changed to read as follows: 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating the interest to 

FDA by October 26, 2009, for vacancies 

listed in the notice. Concurrently, 

nomination material for prospective 

candidates should be sent to the FDA by 

October 26, 2009. 

On page 43140, in the first column, 

the ADDRESSES portion of the document 

is changed to read as follows: 

ADDRESSES: All nominations for 

membership should be sent to Teresa L. 

Hays, Food and Drug Administration, 

Center for Tobacco Products, 9200 

Corporate Blvd., Rockville, MD 20850– 

3229, 301–796–3699, FAX: 301–595– 

7946, e-mail: Teresa.Hays@fda.hhs.gov. 

On page 43141, beginning in the first 

column, the text in the II. Selection 

Procedure portion of the document is 

changed to read as follows: 

Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see ADDRESSES) within 30 days 

of publication of this document. Within 

the subsequent 30 days, FDA will send 

a letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for the Tobacco Products 

Scientific Advisory Committee. The 

interested organizations are not bound 

by the list of nominees in selecting a 

candidate. However, if no individual is 

selected within 60 days, the 

Commissioner of Food and Drugs will 

select the nonvoting member to 

represent industry interests. 

This notice is issued under the 

Federal Advisory Committee Act (5 

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

relating to the advisory committees. 

Dated: September 18, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23009 Filed 9–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

National Protection and Programs 

Directorate; Infrastructure Protection 

Data Call Survey 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: 60-Day Notice and request for 

comments; New Information Collection 

Request: 1670—NEW. 

SUMMARY: The Department of Homeland 

Security, National Protection and 

Programs Directorate, has submitted the 

following Information Collection 

Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995 (Pub. L. 104–13, 44 U.S.C. Chapter 

35). 

DATES: Comments are encouraged and 

will be accepted until November 23, 

2009. This process is conducted in 

accordance with 5 CFR 1320.1. 

ADDRESSES: Written comments and 

questions about this Information 

Collection Request should be forwarded 

to NPPD/IP/IICD, Attn.: Mary MathenyRushdan, mary.mathenyrushdan@dhs.gov. 

SUPPLEMENTARY INFORMATION: The U.S. 

Department of Homeland Security 

(DHS) is the lead coordinator in the 

national effort to identify and prioritize 

the country’s critical infrastructure and 

key resources (CIKR). At DHS, this 

responsibility is managed by the Office 

of Infrastructure Protection (IP) in the 

National Protection and Programs 

Directorate (NPPD). In FY2006, IP 

engaged in the annual development of a 

list of CIKR assets and systems to 

improve IP’s CIKR prioritization efforts; 

this list is called the Critical 

Infrastructure List. The Critical 

Infrastructure List includes assets and 

systems that, if destroyed, damaged or 

otherwise compromised, could result in 

significant consequences on a regional 

or national scale. 

The IP Data Call is administered out 

of the Infrastructure Information 

Collection Division (IICD) in the Office 

of Infrastructure Protection (IP). The IP 

Data Call provides opportunities for 

States and territories to collaborate with 

DHS and its Federal partners in CIKR 

protection. DHS, State and territorial 

Homeland Security Advisors (HSA), 

Sector Specific Agencies (SSA), and 

territories build their CIKR data using 

the IP Data Call application. To ensure 

that HSAs, SSAs and territories are able 

to achieve this mission, IP requests 

opinions and information in a survey 

from IP Data Call participants regarding 

the IP Data Call process and the Webbased application used to collect the 

CIKR data. The survey data collected is 

for internal IICD and IP use only. 

IICD and IP will use the results of the 

IP Data Call Survey to determine levels 

of customer satisfaction with the IP Data 

Call process and the IP Data Call 

application and prioritize future 

improvements. The results will also 

allow IP to appropriate funds costeffectively based on user need, and 

improve the process and application. 

The Office of Management and Budget 

is particularly interested in comments 

which: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. 

Analysis 

Agency: Department of Homeland 

Security, National Protection and 

Programs Directorate. 

Title: IP Data Call Survey. 

Form: Not Applicable. 

OMB Number: 1670—NEW. 

Affected Public: State, Local, or Tribal 

Government. 

Number of Respondents: 138. 

Estimated Time per Respondent: 2 

hours. 

Total Burden Hours: 276. 


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