40204 Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices 

PHASE VI ESTIMATE OF RESPONDENT BURDEN—Continued 

[Note: Total burden is annualized over a 5-year period] 

Instrument Respondent Number of 

respondents 

Total average 

number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

5-Year average annual 

burden hours 

Total Summary ............ 13,274 ................................ ........................ 271,439 ........................ 28,156 

1An average of 23 stakeholders in up to 26 grant communities will complete the System of Care Assessment interview. These stakeholders 

will include site administrative staff, providers, agency representatives, family representatives, and youth. 2 Number of respondents across 26 grantees (5223), in addition to 318 children/families from the comparison sample. Average based on a 5 

percent attrition rate at each data collection point. 3 Number of responses per respondent is five over the course of the study (once every 6 months for 24 months, with one baseline/intake response, and 4 follow-up responses). 4Approximate number of caregivers with children over age 5, based on Phase IV data submitted as of 12/08. Also includes 318 children/families from the comparison sample. 5Approximate number of caregivers with children 3 and older, based on Phase IV data submitted as of 12/08. Also includes 318 children/families from the comparison sample. 6Approximate number of caregivers with either: (1) Children served at the roughly 7 early childhood-focused communities, for whom the instrument is required; or (2) children aged 0 to 12 at other communities, where the instrument is optional (we estimate that 1⁄3 of caregivers will be 

administered the instrument when it is optional). Estimates are based on Phase IV data submitted as of 12/08. 7Approximate number of caregivers with either: (1) Children served at the roughly 7 early childhood-focused communities, for whom the instrument is required; or (2) children aged 0 to 5 at other communities, where the instrument is optional (we estimate that 1⁄3 of caregivers will be administered the instrument when it is optional). Estimates are based on Phase IV data submitted as of 12/08. 8Based on Phase IV finding that approximately 63 percent of the children in the evaluation were 11 years old or older. Also includes 318 children/families from the comparison sample. 9With the exception of the MSSC–R, respondents only complete Service Experience Study measures at follow-up points. See Footnote #3 for 

the explanation about the average number of responses per respondent. 10Approximate number of children/families in each sector, for the Sector and Comparison Study. This includes cases within the communities, 

as well as within the comparison sample. 11For each community, 1 respondent will be a caregiver and 3 respondents will be administrators/providers. 12Assumes that each community will use flexible funds expenditures on average for approximately one quarter of the children/youth enrolled. 13Assumes that three expenditures, on average, will be spent on each child/youth receiving flexible fund benefits. 14Assumes that each child/youth in system of care communities and in the comparison sample will have 100 service episodes, on average. 15Total Annual Burden (hours) is the product of Number of Distinct Respondents × Average Annual Number of Responses per Respondent × 

Average 5-Year Burden per Response (hours). 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by September 10, 2009 to: 

SAMHSA Desk Officer, Human 

Resources and Housing Branch, Office 

of Management and Budget, New 

Executive Office Building, Room 10235, 

Washington, DC 20503; due to potential 

delays in OMB’s receipt and processing 

of mail sent through the U.S. Postal 

Service, respondents are encouraged to 

submit comments by fax to: 202–395– 

5806. 

Dated: August 5, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–19228 Filed 8–10–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: ACF Uniform Project 

Description. 

OMB No.: 0970–0139. 

Description: The Administration for 

Children and Families (ACF) has more 

than 50 discretionary grant programs. 

The proposed information collection 

form would be a uniform discretionary 

application form eligible for use by 

grant applicants to submit project 

information in response to ACF program 

announcements. ACF would use this 

information, along with other OMBapproved information collections, to 

evaluate and rank applicants and 

protect the integrity of the grantee 

selection process. All ACF discretionary 

grant programs would be eligible but not 

required to use this application form. 

The application consists of general 

information and instructions; the 

Standard Form 424 series that requests 

basic information, budget information 

and assurances; the Project Description 

requesting the applicant to describe how 

these objectives will be achieved; along 

with assurances and certifications. 

Guidance for the content of information 

requested in the Project Description is 

found in OMB Circular A–102 and 45 

CFR Part 74. 

Respondents: Applicants for ACF 

Discretionary Grant Programs. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

UPD ............................................................................................................... 6,752 1 40 270,080 

Estimated Total Annual Burden 

Hours: 270,080 

Additional Information: Copies of the 

proposed collection may be obtained 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. All requests 

should be identified by the title of the 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices 40205 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7245, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: August 6, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–19170 Filed 8–10–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0053] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; NPLATE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

NPLATE 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 biological 

product. 

ADDRESSES: Submit written or electronic 

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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological 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 biological product 

and continues until FDA grants 

permission to market the biological 

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 biological 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 biologic product NPLATE 

(romiplostim). NPLATE is indicated for 

the treatment of thrombocytopenia in 

patients with chronic immune 

(idiopathic) thrombocytopenic purpura 

(ITP) who have had an insufficient 

response to corticosteroids, 

immunoglobulins, or splenectomy. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

NPLATE (U.S. Patent No. 6,835,809) 

from Amgen Inc., 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 26, 2009, FDA 

advised the Patent and Trademark 

Office that this human biological 

product had undergone a regulatory 

review period and that the approval of 

NPLATE 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 

NPLATE is 2,319 days. Of this time, 

2,014 days occurred during the testing 

phase of the regulatory review period, 

while 305 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 (21 U.S.C. 355(i)) 

became effective: April 19, 2002. The 

applicant claims April 23, 2002, as the 

date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was April 19, 2002, 

the date of the FDA correspondence 

removing the clinical hold on the 

application. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): October 23, 2007. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

NPLATE (BLA 125268/0) was initially 

submitted on October 23, 2007. 

3. The date the application was 

approved: August 22, 2008. FDA has 

verified the applicant’s claim that BLA 

125268/0 was approved on August 22, 

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 818 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 October 13, 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 

February 8, 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 


sroberts on DSKD5P82C1PROD with NOTICES