Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices 55403 

families. Families that apply (or 

reapply) for subsidies and are 

determined to be eligible under current 

rules will be randomly assigned to the 

experimental co-payment schedule or 

the existing schedule. (Families with copayments from the experimental 

schedule will either pay the same 

amount, or less, than families whose copayments are calculated using the 

existing schedule.) Families will retain 

the same co-payment schedule for two 

years, provided they continue to be 

eligible for subsidies. Outcomes will be 

measured through analysis of 

administrative data and periodic 

interviews with parents. 

Massachusetts. In Massachusetts, the 

study is an experimental test of the 

effectiveness of a developmental 

curriculum implemented in family child 

care homes. Family child care providers 

who serve subsidized and other lowincome children and are linked to 

family child care networks will be 

randomly assigned to a treatment or 

control group. Providers in the 

treatment group will use the 

developmental curriculum and be 

trained through regular visits to the 

home by specially trained mentors. 

These providers will receive materials 

to use with children from 0 to 5 years 

of age. Providers in the control group 

will receive the more general technical 

assistance and support visits that they 

currently receive. Impacts on provider 

behavior and the home environment 

will be measured through direct 

observations in the homes. Child 

assessments will be conducted through 

provider reports for the younger 

children and through standardized tests 

for children 30 months and older. 

Respondents: Illinois. Parents who 

apply (or reapply) for subsidies and are 

eligible and agree to be in the study will 

be interviewed by telephone up to three 

times in the 24 months after they enter 

the study. 

Washington State. Parents who apply 

(or reapply) for subsidies and are 

eligible and agree to be in the study will 

be interviewed by telephone up to three 

times over the 24 months of the study. 

Approximately 30 state employees 

working at the Department of Health 

and Human Services in the Division of 

Child Care and Early Learning or the 

Division of Community Service will be 

interviewed as part of the 

implementation study. 

Massachusetts. Children will be 

assessed 7 months after implementing 

the curriculum, after 11 months, and 

after 23 months. Providers will be asked 

to respond to a brief survey 7 and 23 

months after the study begins. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

Illinois parent survey .................................................................................... 5,000 1 .5 .58 4,350 

Washington parent survey ........................................................................... 2,000 1 .5 .58 1,740 

Washington process study interview ........................................................... 30 .5 .5 8 

Massachusetts child assessments .............................................................. 700 1 .5 .5 525 

Massachusetts provider questionnaire ........................................................ 350 1 .16 56 

Estimated Total Annual Burden 

Hours: 6,679. 

In compliance with the requirements 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information colleciton described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

grjohnson@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: September 15, 2005. 

Robert Sargis, 

Reports Clearance, Officer. 

[FR Doc. 05–18771 Filed 9–20–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Refugee Resettlement 

Grant to United States Conference of 

Catholic Bishops 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families (ACF), Department of Health 

and Human Services (DHHS). 

ACTION: Award announcement. 

CFDA#: The Catalog of Federal Domestic 

Assistance (CFDA) number for this program 

is 93.576. The title is the Refugee Family 

Enrichment Program. 

Amount of Award: $194,000. 

SUMMARY: Notice is hereby given that a 

noncompetitive single source program 

expansion supplement to an ongoing 

competitive award is being made to the 

United States Conference of Catholic 

Bishops (USCCB) in response to an 

unsolicited application. The application 

is not within the scope of any existing 

or expected to be issued program 

announcement for the Fiscal Year 2006. 

USCCB’s application is expected to 

address issues critical to the 

development and implementation of 

marriage education programs for 

refugees by opening three new program 

sites. 

In September of 2003, ORR awarded 

USCCB a grant of $1,000,000,000 to 

develop a Refugee Family Enrichment 

program which included technical 

assistance to subgrantees. Over the past 

two years, USCCB has established an 

effective program in sites that have 

successfully prepared thousands of 

refugee families for the challenges they 

will face during resettlement. Because 

other Refugee Marriage Enrichment 

grantees are primarily regional in scope, 

we believe USCCB is uniquely suited to 

effectively implement this supplemental 

award. USCCB has affiliates across the 

country and has no physical or 

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