Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices 22749 

Dated: May 6, 2009. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. E9–11150 Filed 5–13–09; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; The Impact of Continuing 

Medical Education on Physician 

Practice 

SUMMARY: In compliance with the 

requirement of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

Clinical Center, the National Institutes 

of Health will publish periodic 

summaries of proposed projects to be 

submitted to the Office of Management 

and Budget for review and approval. 

Proposed Collection: Title: The impact 

of Continuing Medical Education on 

physician practice: Type of Information 

Collection Request: NEW. Need and Use 

of Information Collection: This study 

will assess the value of the Continuing 

Medical Education conferences held at 

the NIH. The primary objective of the 

survey is to determine if conferences 

have had an impact on whether the 

physician has changed their practice as 

a result of the information presented in 

the conference. Frequency of response: 

On occasion. Affected Public: 

Physicians, dentists, nurses, and other 

health care providers. The annual 

reporting burden is as follows: 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

requested 

Doctoral Level .................................................................................................. 7,500 2 0.017 255 

Other Health Care Provider ............................................................................. 2,500 2 0.017 85 

Total .......................................................................................................... ........................ ........................ ........................ 340 

There are no Capital Costs, Operating 

Costs, and/or Maintenance Costs to 

report. 

Request For Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of 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 used; (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. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Linda Wisniewski, 

Nurse Consultant, Office of Clinical 

Research Training and Medical 

Education, CC, NIH, Building 10, Room 

1N252B, 9000 Rockville Pike, Bethesda, 

MD 20892 or 301–496–9425 or e-mail 

your request, including your address to: 

wisniewskil@cc.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Laura Lee, 

Project Clearance Liaison, Warren Grant 

Magnuson Clinical Center, National Institutes 

of Health. 

[FR Doc. E9–11308 Filed 5–13–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Title IV–E Programs Quarterly 

Financial Report. 

OMB No.: 0970–0205. 

Description: Historically, State 

agencies have administered programs 

under title IV–E of the Social Security 

Act for the Foster Care and Adoption 

Assistance Programs. The 

Administration for Children and 

Families provides Federal funding at the 

rate of 50 percent for most of the 

administrative costs of these programs 

and at other rates for other specific 

categories of costs as detailed in Federal 

statute and regulations. 

The enactment of Public Law 110– 

351, the ‘‘Fostering Connections to 

Success and Increasing Adoptions Act 

of 2008’’ introduced two major changes 

to the title IV–E programs: (1) The 

inception of the Guardianship 

Assistance Program for all grantees, 

effective October 1, 2008 and, (2) the 

availability of these programs to Tribes 

and Tribal Organizations, effective 

October 1, 2009. 

We anticipate that this form will be 

revised and redesigned to be applicable 

to both State and Tribal grantees. 

This form is submitted quarterly by 

each State or Tribe to estimate its 

funding needs for the upcoming fiscal 

quarter and to report expenditures for 

the fiscal quarter just ended. The 

information collected in this report is 

used by this agency to calculate 

quarterly Federal grant awards and to 

enable oversight of the financial 

management of the programs. 

Respondents: State agencies 

(including the District of Columbia and 

Puerto Rico) and Tribal agencies 

(starting in FY 2010) administering the 

Foster Care, Adoption Assistance and 

Guardianship Assistance programs 

under Title IV–E of the Social Security 

Act. 


pwalker on PROD1PC71 with NOTICES
22750 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Title IV–E Programs Quarterly Financial Report ............................................. 70 4 20 5,600 

Estimated Total Annual Burden 

Hours: 5,600. 

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: 

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: May 6, 2009. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. E9–11149 Filed 5–13–09; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2004–E–0266 (formerly 

2004E–0446), FDA–2004–E–0270 (formerly 

2004E–0391), and FDA–2004–E–0332 

(formerly 2004E–0399)] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; SENSIPAR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

SENSIPAR 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 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 SENSIPAR 

(cinacalcet hydrochloride). SENSIPAR 

is indicated for the treatment of 

secondary hyperparathyroidism in 

patients with chronic kidney disease on 

dialysis and for the treatment of 

hypercalcemia in patients with 

parathyroid carcinoma. Subsequent to 

this approval, the Patent and Trademark 

Office received patent term restoration 

applications for SENSIPAR (U.S. Patent 

Nos. 6,011,068; 6,211,244; and 

6,313,146) from NPS Pharmaceuticals, 

Inc., and the Patent and Trademark 

Office requested FDA’s assistance in 

determining the patents’ eligibilities for 

patent term restoration. In a letter dated 

October 19, 2004, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of SENSIPAR 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 

SENSIPAR is 2,089 days. Of this time, 

1,906 days occurred during the testing 

phase of the regulatory review period, 

while 183 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 


pwalker on PROD1PC71 with NOTICES