50800 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices 

11,919. (For policy questions regarding 

this collection contact Marla Rothouse 

at 410–786–8063. For all other issues 

call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

E-mail your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on November 2, 2009. 

OMB, Office of Information and 

Regulatory Affairs, 

Attention: CMS Desk Officer. 

Fax Number: (202) 395–6974. 

E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: September 24, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–23707 Filed 9–30–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–08AU] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Assessing Problem Areas in Referrals 

for Chronic Hematologic Malignancies 

and Developing Interventions to 

Address Them—New—Division of 

Cancer Prevention and Control (DCPC), 

National Center for Chronic Disease 

Prevention and Health Promotion 

(NCCDPHP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Despite the advent of new diagnostics 

and therapeutics for patients with 

chronic hematological malignancies, 

data from the United States, Europe and 

Canada allude to a problem of timely 

referral and diagnosis for patients with 

cancer. Improving the timeliness of care 

and referral to appropriate specialists 

are key health care quality objectives. 

CDC proposes to conduct a one-time 

study to collect qualitative and 

quantitative information on optimal and 

suboptimal referral patterns for patients 

with confirmed or suspected chronic 

hematologic malignancies. Information 

will be collected to identify specific 

factors related to delays in diagnosis 

and/or referral to appropriate medical 

specialists. Information will be collected 

through in-depth interviews with 

hematologic cancer patients, in-depth 

interviews and focus groups with 

primary care providers, interviews with 

specialists in hematology and oncology, 

and a one-time postal survey to a 

sample of primary care providers (PCP). 

The PCP survey may be completed in 

paper form or via the Web. 

The ultimate goal is to develop tools 

that will improve the awareness, 

diagnosis, and referral of persons with 

chronic hematological cancers by 

primary care providers. 

There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

198. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name No. of 

respondents 

No. of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Community Hematologists/Oncologists .......... Community Hematologists and Oncologists 

Interview Phone Recruitment Script.

100 1 2/60 

Community Hematologists and Oncologists 

Interview Guide.

18 1 1.5 

Patients ........................................................... Patient Interview Phone Recruitment Script .. 50 1 2/60 

Patient Interview Guide .................................. 18 1 1.5 

Primary Care Providers (PCP) ....................... PCP Survey Cover Letter ............................... 250 1 2/60 

PCP Survey .................................................... 150 1 20/60 

PCP Opt-Out Card ......................................... 100 1 2/60 

PCP Survey Reminder Letter ......................... 200 1 2/60 

PCP Interview Phone Recruitment Script ...... 100 1 3/60 

PCP Interview Guide ...................................... 18 1 1.5 

PCP Focus Group Phone Recruitment Script 50 1 3/60 

PCP Focus Group Guide ............................... 18 1 2 


PWALKER on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices 50801 

Dated: September 20, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–23681 Filed 9–30–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–E–0017 and FDA– 

2009–E–0019] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CLEVIPREX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

CLEVIPREX 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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

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 drug 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 CLEVIPREX 

(clevidipine butyrate). CLEVIPREX is 

indicated for the reduction of blood 

pressure when oral therapy is not 

feasible or not desirable. Subsequent to 

this approval, the Patent and Trademark 

Office received patent term restoration 

applications for CLEVIPREX (U.S. 

Patent Nos. 5,739,152 and 5,856,346) 

from AstraZeneca AB, and the Patent 

and Trademark Office requested FDA’s 

assistance in determining the patents’ 

eligibilities for patent term restoration. 

In a letter dated February 18, 2009, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of CLEVIPREX 

represented the first permitted 

commercial marketing or use of the 

product. 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 

CLEVIPREX is 4,475 days. Of this time, 

4,078 days occurred during the testing 

phase of the regulatory review period, 

while 397 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 CosmeticAct (the act) (21 U.S.C. 

355(i)) became effective: May 3, 1996. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on May 3, 1996. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: July 2, 2007. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) 22–156 

was submitted on July 2, 2007. 

3. The date the application was 

approved: August 1, 2008. FDA has 

verified the applicant’s claim that NDA 

22–156 was approved on August 1, 

2008. 

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 1,314 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 30, 2009. 

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 30, 2010. 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: June 23, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–23650 Filed 9–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0461] 

Draft Guidance for Industry on Format 

and Content of Proposed Risk 

Evaluation and Mitigation Strategies 

(REMS), REMS Assessments, and 

Proposed REMS Modifications; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 


PWALKER on DSK8KYBLC1PROD with NOTICES