45862 Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 

Assessment of Fall Prevention 

Programs. This approval expires on 

7/31/10. At this time we are requesting 

a two year extension to collect data. 

NCIPC seeks to examine cost of 

implementing each of the three AoAfunded fall prevention programs for 

older adults (Stepping On, Moving for 

Better Balance and Matter of Balance) 

and to assess the maintenance of fall 

prevention behaviors among 

participants six months after completing 

the Matter of Balance program. 

To assess the maintenance of fall 

prevention behaviors, CDC’s contractor, 

Booz Allen Hamilton, will conduct 

telephone interviews of 300 Matter of 

Balance program participants six 

months after they have completed the 

program. The interview will assess their 

knowledge and self-efficacy related to 

falls as taught in the course, their 

activity and exercise levels, and their 

reported falls both before and after the 

program. The results of the follow-up 

assessment will determine the extent to 

which preventive behaviors learned 

during the Matter of Balance program 

are maintained and can continue to 

reduce fall risk. 

The cost assessment will calculate the 

lifecycle cost of the Stepping On, 

Moving for Better Balance, and Matter of 

Balance programs. The cost analysis 

will include calculating the investment 

costs required to implement each 

program, as well as the ongoing 

operational costs associated with each 

program. These costs will be allocated 

over a defined period of time, 

depending on the average or standard 

amount of time these programs continue 

to operate (standard lifecycle analysis 

ranges from five to 10 years). The data 

obtained from the lifecycle cost 

calculation will allow us to compare 

program costs and to identify specific 

cost drivers, cost risks, and unique 

financial attributes of each program. 

Local program coordinators for the 

200 sites in each of the AoA-funded 

states will collect the cost data using 

lifecycle cost spreadsheets that will be 

returned to CDC’s contractor for 

analysis. Booz Allen Hamilton has been 

contracted by CDC to conduct the data 

collection and analysis. 

The results of these studies will 

support the replication and 

dissemination of these fall prevention 

programs and enable them to reach 

more older adults. States require data on 

impact and cost in order to obtain 

sustainable and supplemental funding 

to maintain programs after funding from 

AoA ends. 

There are no costs to respondents 

other than their time. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses 

Average 

burden 

per response 

(in hours) 

Total burden 

(in hours) 

Program Coordinators ....................... Cost Assessment ............................. 200 1 2 400 

Program Participants ........................ Impact Survey .................................. 300 1 1 300 

Total ........................................... ........................................................... ........................ ........................ ........................ 700 

Dated: August 28, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–21377 Filed 9–3–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; NCCAM Customer Service 

Data Collection 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Center for Complementary and 

Alternative Medicine (NCCAM), the 

National Institutes of Health (NIH), will 

submit to the Office of Management and 

Budget (OMB) a request for review and 

approval of the information collection 

listed below. A notice of this proposed 

information collection was previously 

published in the Federal Register on 

June 26, 2009 (Volume 74, Number 122, 

page 30577). To date, no public 

comments have been received. The 

purpose of this notice is to announce a 

final 30 days for public comment. NIH 

may not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

Proposed Collection 

Title: NCCAM Customer Service Data 

Collection. 

Type of Information Collection 

Request: Revision. 

Need and Use of Information 

Collection: NCCAM provides the public, 

patients, families, health care providers, 

complementary and alternative 

medicine (CAM) practitioners, and 

others with the latest scientifically 

based information on CAM and 

information about NCCAM’s programs 

through a variety of channels, including 

its toll-free telephone information 

service. NCCAM wishes to continue to 

measure customer satisfaction with 

NCCAM telephone interactions and to 

assess which audiences are being 

reached through these channels. This 

effort involves a telephone survey 

consisting of 10 questions, which 25 

percent of all callers are asked to 

answer, for an annual total of 

approximately 983 respondents. 

NCCAM uses the data collected from the 

survey to help program staff measure 

the impact of their communication 

efforts, tailor services to the public and 

health care providers, measure service 

use among special populations, and 

assess the most effective media and 

messages to reach these audiences. 

Frequency of Response: Once. 

Affected Public: Individuals and 

households. 

Type of Respondents: Patients, 

spouses/family/friends of patients, 

health care providers, physicians, CAM 

practitioners, or other individuals 

contacting the NCCAM Clearinghouse. 

The annual reporting burden is as 

follows: 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 45863 

A.12–1—ESTIMATES OF HOUR BURDEN

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

requested 

Telephone survey 

Individuals or households ................................................................................ 919 1 0.075 69 

Physicians ........................................................................................................ 44 1 0.075 3 

CAM/health practitioners ................................................................................. 20 1 0.075 1 

The annualized cost to respondents is 

estimated at $1,479 for the telephone 

survey. There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on the following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions; (3) Ways 

to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Christy 

Thomsen, Director, Office of 

Communications and Public Liaison, 

NCCAM, 31 Center Drive, Room 2B–11, 

Bethesda, MD 20892–2182; or fax your 

request to 301–402–4741; or e-mail 

thomsenc@mail.nih.gov. Ms. Thomsen 

can be contacted by telephone at 301– 

451–8876. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: August 27, 2009. 

Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health. 

[FR Doc. E9–21479 Filed 9–3–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–E–0266] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; DORIBAX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

DORIBAX 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 DORIBAX 

(doripenem monohydrate). DORIBAX is 

indicated in the treatment of the 

following infections caused by 

designated susceptible bacteria: 

complicated intra-abdominal infections, 

and complicated urinary tract 

infections, including pyelonephritis. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

DORIBAX (U.S. Patent No. 5,317,016) 

from Shionogi Seiyaku Kabushiki 

Kaisha, 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 18, 2009, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 


srobinson on DSKHWCL6B1PROD with NOTICES