55404 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices 

programmatic limitations regarding 

which ethnic groups they can serve. We 

believe that by allowing them to 

increase the number of sites, that it 

would be a cost-effective way of helping 

more refugees develop the skills that 

help their marriages succeed and give 

their children a better chance of success 

in the U.S. Without it, these sites might 

struggle to provide refugee clients with 

the programs they need in order to 

achieve self-sufficiency. 

The proposed project period is 9/30/ 

2005–9/29/2006. 

Assistance to support grantees in 

developing better approaches to the 

delivery of services provided to refugees 

is authorized by section 412(c)(1)(A) of 

the Immigration and Nationality Act (8 

U.S.C. 1522(c)(1)). 

FOR FURTHER INFORMATION CONTACT: 

Administration for Children and 

Families, Office of Refugee 

Resettlement, 370 L’Enfant Promenade, 

SW., Washington, DC 20447, Loren 

Bussert—(202) 401–4732, 

lbussert@acf.hhs.gov. 

Dated: September 15, 2005. 

Nguyen Van Hanh, 

Director, Office of Refugee Resettlement. 

[FR Doc. 05–18847 Filed 9–20–05; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0143] 

High Chemical Co. et al.; Withdrawal of 

Approval of 13 New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 13 new drug applications 

(NDAs) from multiple holders of these 

applications. The basis for the 

withdrawals is that the holders of the 

applications have repeatedly failed to 

file required annual reports for the 

applications. 

DATES: Effective September 21, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041. 

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). In the Federal 

Register of January 28, 2005 (70 FR 

4134), FDA published a notice offering 

an opportunity for a hearing (NOOH) on 

a proposal to withdraw approval of 13 

NDAs because the firms had failed to 

submit the required annual reports for 

these applications. On April 28, 2005, 

the agency withdrew that notice (70 FR 

22054) and reissued the corrected 

NOOH (70 FR 22052). FDA received two 

responses to the NOOH: 

1. The Kendall Co. (Kendall), 15 

Hampshire St., Mansfield, MA 02048, 

notified the agency that they no longer 

market the following products: NDA 10–

337, Fling Antiperspirant Foot Powder; 

NDA 10–823, BIKE Foot and Body 

Powder; and NDA 10–824, BIKE AntiFungal Aerosol Spray. Kendall informed 

FDA that their historical files show they 

sold their rights to these three products 

(including the licenses) many years ago; 

however, they did not notify the agency 

of the sale. Because Kendall sold the 

products many years ago, they have no 

record of the new application holder. 

Neither The Kendall Co. nor the new 

license holder requested a hearing. 

2. Bayer HealthCare LLC, Biological 

Products Division, 800 Dwight Way, 

Berkeley, CA 94701–1966, notified the 

agency that NDA 10–541, BY-NA-MID 

(Butylphenamide or B and Zinc Oxide 

or Stearate) Tincture, Ointment, Lotion, 

and Powder, is not a product produced 

at their Berkeley site, and that they 

would forward the NOOH to Bayer 

HealthCare LLC, Pharmaceutical 

Division, 400 Morgan Lane, West 

Haven, CT 06516–4175. Bayer 

HealthCare LLC in West Haven, CT, 

informed the agency that NDA 10–541, 

BY-NA-MID, is not their product and 

that they have no regulatory files for this 

product. Bayer HealthCare LLC did not 

request a hearing. 

No other firms responded to the 

NOOH. Failure to file a written notice 

of participation and request for hearing 

as required by § 314.200 (21 CFR 

314.200) constitutes an election by the 

applicant not to make use of the 

opportunity for a hearing concerning the 

proposal to withdraw approval of the 

applications and a waiver of any 

contentions concerning the legal status 

of the drug products. Therefore, the 

Director, Center for Drug Evaluation and 

Research, is withdrawing approval of 

the 13 applications listed in the table of 

this document. 

Application 

No. 

Drug Applicant 

NDA 0–

763 

Sterile Solution 

Procaine Injection 2% (Procaine Hydrochloride (HCl)) 

High Chemical 

Co., 1760 N. 

Howard St., 

Philadelphia, PA 

19122 

NDA 2–

959 

Nicotinic Acid 

(Niacin) Tablets 

The Blue Line 

Chemical Co., 

302 South 

Broadway, St. 

Louis, MO 

63102 

NDA 4–

236 

Sherman (thiamine HCl) Elixir Do. 

NDA 4–

368 

Ascorbic Acid 

Tablets 

Do. 

NDA 5–

159 

D.S.D. 

(diethylstilbestrol 

dipropionate) 

Do. 

NDA 9–

452 

Multifuge (piperazine citrate) 

Syrup 

Do. 

NDA 

10–

055 

Fire Gard ThreeAlarm Burn Relief 

(Methylcellulose) 

Gard Products, 

Inc., 2560 Tara 

Lane, Brunswick, GA 31520 

NDA 

10–

337 

Fling Antiperspirant Foot 

Powder 

Bauer & Black, 

A Division of 

The Kendall Co., 

One Federal St., 

Boston, MA 

02110 

NDA 

10–

541 

BY-NA-MID 

(Butylphenamide 

or B and Zinc 

Oxide or Stearate) Tincture, 

Ointment, Lotion, and Powder 

Miles Inc., Cutter 

Biological, P.O. 

Box 1986, 

Berkeley, CA 

94701 

NDA 

10–

823 

BIKE Foot and 

Body Powder 

Bauer & Black, 

A Division of 

The Kendall Co. 

NDA 

10–

824 

BIKE AntiFungal Aerosol 

Spray 

Do. 

NDA 

11–

233 

TKO with Entrin 

Roll-On Liquid 

Modern-Labs, 

Inc., Maple Rd., 

Gambrills, MD 

21504 

NDA 

19–

432 

Spectamine 

(Iofetamine Hydrochloride I–

123) Injection 

IMP Inc., 8050 

El Rio, Houston, 

TX 77054 

The Director, Center for Drug 

Evaluation and Research, under section 

505(e) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(e)), and 

under authority delegated by the 

Commissioner of Food and Drugs, finds 

that the holders of the applications 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices 55405 

listed in this document have repeatedly 

failed to submit reports required by 

§ 314.81. In addition, under § 314.200, 

we find that the holders of the 

applications have waived any 

contentions concerning the legal status 

of the drug products. Therefore, under 

these findings, approval of the 

applications listed in this document, 

and all amendments and supplements 

thereto, is hereby withdrawn, effective 

September 21, 2005. 

Dated: August 29, 2005. 

Steven Galson, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 05–18873 Filed 9–20–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Industry Exchange Workshop on Food 

and Drug Administration Clinical Trial 

Requirements; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Dallas District, in 

cooperation with the Society of Clinical 

Research Associates (SoCRA), is 

announcing a workshop on FDA clinical 

trial statutory and regulatory 

requirements. This 2-day workshop for 

the clinical research community targets 

sponsors, monitors, clinical 

investigators, institutional review 

boards, and those who interact with 

them for the purpose of conducting 

FDA-regulated clinical research. The 

workshop will include both industry 

and FDA perspectives on proper 

conduct of clinical trials regulated by 

FDA. 

Date and Time: The public workshop 

is scheduled for Wednesday, February 

8, 2006, from 8:15 a.m. to 5 p.m. and 

Thursday, February 9, 2006, from 8:15 

a.m. to 4 p.m. 

Location: The public workshop will 

be held at the Crowne Plaza Hotel 

Houston Medical Center, 6701 South 

Main, Houston, TX 77030, 713–797–

1110, FAX: 713–796–8291. 

Contact: David Arvelo, Food and Drug 

Administration, 4040 North Central 

Expressway, suite 900, Dallas, TX 

75204, 214–253–4952, FAX: 214–253–

4970, e-mail: oraswrsbr@ora.fda.gov. 

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) and the registration fee of $485 

(member), $560 (nonmember), or $460 

(government employee nonmember). 

(Registration fee for nonmembers 

includes a 1-year membership.) The 

registration fee for FDA employees is 

waived. Make the registration fee 

payable to SoCRA, P.O. Box 101, 

Furlong, PA 18925. To register via the 

Internet go to http://www.socra.org/ 

html/FDA_Conference.htm (FDA has 

verified the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register). The 

registrar will also accept payment by 

major credit cards. For more 

information on the meeting, or for 

questions on registration, contact 800–

SoCRA92 (800–762–7292), or 215–345–

7369, or via e-mail: socramail@aol.com. 

Attendees are responsible for their own 

accommodations. To make reservations 

at the Crowne Plaza Hotel Houston 

Medical Center at the reduced 

conference rate, contact the Crowne 

Plaza Hotel Houston Medical Center 

(see Location) before January 17, 2005. 

The registration fee will be used to 

offset the expenses of hosting the 

conference, including meals, 

refreshments, meeting rooms, and 

materials. 

Space is limited, therefore interested 

parties are encouraged to register early. 

Limited onsite registration may be 

available. Please arrive early to ensure 

prompt registration. If you need special 

accommodations due to a disability, 

please contact David Arvelo (see 

Contact) at least 7 days in advance of 

the workshop. 

SUPPLEMENTARY INFORMATION: The 

workshop on FDA clinical trials 

statutory and regulatory requirements, 

helps fulfill the Department of Health 

and Human Services and FDA’s 

important mission to protect the public 

health by educating researchers on 

proper conduct of clinical trials. Topics 

for discussion include the following: (1) 

FDA regulation of the conduct of 

clinical research; (2) medical device, 

drug, and biological product aspects of 

clinical research; (3) investigator 

initiated research; (4) pre-investigational 

new drug application meetings and FDA 

meeting process; (5) informed consent 

requirements; (6) ethics in subject 

enrollment; (7) FDA regulation of 

institutional review boards; (8) 

electronic records requirements; (9) 

adverse event reporting; (10) how FDA 

conducts bioresearch inspections; and 

(11) what happens after the FDA 

inspection. FDA has made education of 

the research community a high priority 

to ensure the quality of clinical data and 

protect research subjects. The workshop 

helps to implement the objectives of 

section 406 of the FDA Modernization 

Act (21 U.S.C. 393) and the FDA Plan 

for Statutory Compliance, which 

includes working more closely with 

stakeholders and ensuring access to 

needed scientific and technical 

expertise. The workshop also furthers 

the goals of the Small Business 

Regulatory Enforcement Fairness Act 

(Public Law 104–121) by providing 

outreach activities by Government 

agencies directed to small businesses. 

Dated: September 15, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18871 Filed 9–20–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Psychopharmacologic 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: 

Psychopharmacologic 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 October 25, 2005, from 8 a.m. 

to 5 p.m. and on October 26, 2005, from 

8 a.m. to 3 p.m. 

Location: Hilton, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD. The 

hotel phone number is 301–977–8900. 

Contact Person: Karen TempletonSomers, 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: 

somersk@cder.fda.gov, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512544. Please call the Information 

Line for up-to-date information on this 

meeting. The background material will 

become available no later than the day 

before the meeting and will be posted 

on FDA’s Web site at http://