55798 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Burden category 

Number of respondents per 

year 

Number of responses per 

respondent 

Average burden per response 

(hours) 

1. Screening interview only ......................................................................................................... 13,333 1 10/60 

2. Screener, family, and sample person interviews only ............................................................ 300 1 1.10 

3. Screener, family, and sample person interviews and MEC examination (including pilot 

studies) ..................................................................................................................................... 5,180 1 5.9 

4. Second dietary recall interview ............................................................................................... 4,300 1 30/60 

5. Telephone Interview (FCBS) ................................................................................................... 3,000 1 20/60 

6. Follow-up, special studies, and tests of procedures ............................................................... 4,000 1 5.9 

Dated: September 19, 2006. 

Joan F. Karr, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 06–8164 Filed 9–22–06; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: DHHS/ACF/ASPE/DOL 

Enhanced Services for the Hard-toEmploy Demonstration and Evaluation: 

Rhode Island 15-Month Survey 

Amendment. 

OMB No. 0970–0276. 

Description: The Enhanced Services 

for the Hard-to-Employe Demonstration 

and Evaluation Project (HtE) seeks to 

learn what works in this area to date 

and is explicitly designed to build on 

past research by rigorously testing a 

wide variety of approaches to promote 

employment and improve family 

functioning and child well-being. The 

HtE project is designed to help 

Temporary Assistance for Needy 

Families (TANF) recipients, former 

TANF recipients, or low-income parents 

who are hard-to-employ. The project is 

sponsored by the Office of Planning, 

Research and Evaluation (OPRE) of the 

Administration for Children and 

Families (ACF), the Office of the 

Assistant Secretary for Planning and 

Evaluation (ASPE) in the U.S. 

Department of Health and Human 

Services (HHS), and the U.S. 

Department of Labor (DOL). 

The evaluation involves an 

experimental, random assignment 

design in four sites, testing a diverse set 

of strategies to promote employment for 

low-income parents who face serious 

obstacles to employment. The four 

include: (1) Intensive care management 

to facilitate the use of evidence-based 

treatment for major depression among 

parents receiving Medicaid in Rhode 

Island; (2) job readiness training, 

worksite placements, job coaching, job 

development and other training 

opportunities for recent parolees in New 

York City; (3) pre-employment services 

and transitional employment for longterm TANF participants in Philadelphia; 

and (4) home- and center-based care, 

enhanced with self-sufficiency services, 

for low-income families who have 

young children or are expecting in 

Kansas and Missouri. 

Materials for follow-up surveys for 

each of these sites were previously 

submitted to OMB and were approved. 

The purpose of this submission is to add 

physiological measures to the follow-up 

effort to the Rhode Island study. 

Respondents: The respondents to this 

component of the Rhode Island followup survey will be low-income parents 

and their children from the Rhode 

Island site currently participating in the 

HtE Project. As described in the prior 

OMB submission, these parents are 

Medicaid recipients between the ages of 

18 and 45 receiving Medicaid through 

the managed care provider United 

Behavioral Health (UBH) in Rhode 

Island who meet study criteria with 

regard to their risk for depression. 

Children are the biological, adopted, 

and step-children of these parents, 

between the ages of 1 and 18 years of 

age. 

The annual burden estimates are 

detailed below, and the substantive 

content of each component will be 

detailed in the supporting statement 

attached to the forthcoming 30-day 

notice. 

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per response Total burden 

hours 

RI 15-month, parent physiological component ....................... 400 8 5 minutes or .08 hrs .............. 266.66 

RI 15-month young child physiological component ................ 160 8 5 minutes or .08 hrs .............. 106.66 

RI 15-month youth physiological component .......................... 242 8 5 minutes or .08 hrs .............. 161.33 

Estimated Total Annual Burden 

Hours: 534.65. 

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 collection 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: 

infocollection@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 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Notices 55799 

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 19, 2006. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 06–8110 Filed 9–22–06; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0031] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CLOLAR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

CLOLAR and is publishing this notice of 

that determination as required by law. 

FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–007), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the drug product. Although only a 

portion of a regulatory review period 

may count toward the actual amount of 

extension that the Director of Patents 

and Trademarks may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product CLOLAR 

(clofarabine). CLOLAR is indicated for 

the treatment of pediatric patients 1 to 

21 years old with relapsed or refractory 

acute lymphoblastic leukemia after at 

least two prior regimens. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for CLOLAR (U.S. Patent 

No. 5,661,136) from Southern Research 

Institute, and the Patent and Trademark 

Office requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

February 24, 2006, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of CLOLAR represented the 

first permitted commercial marketing or 

use of the product. Shortly thereafter, 

the Patent and Trademark Office 

requested that FDA determine the 

product’s regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

CLOLAR is 2,200 days. Of this time, 

1,926 days occurred during the testing 

phase of the regulatory review period, 

while 274 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: December 22, 

1998. The applicant claims February 10, 

1999, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was December 22, 

1998, the date FDA removed the clinical 

hold on the application. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: March 30, 2004. The 

applicant claims September 26, 2003, as 

the date the new drug application 

(NDA) for CLOLAR (NDA 21–673) was 

initially submitted. However, FDA 

records indicate that NDA 21–673 was 

submitted in its entirety on March 30, 

2004. 

3. The date the application was 

approved: December 28, 2004. FDA has 

verified the applicant’s claim that NDA 

21–673 was approved on December 28, 

2004. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,303 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by November 24, 2006. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

March 26, 2007. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: September 1, 2006. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 06–8115 Filed 9–22–06; 8:45 am] 

BILLING CODE 4160–01–S 


rwilkins on PROD1PC63 with NOTICES