Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices 54343 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Nonprofit Capacity Building Program Performance Progress Report (PPR) .................................................................................... 35 4 1 140 

Government Capacity Building Program PPR ................................. 49 4 1 196 

Estimated Total Annual Burden 

Hours: 336. 

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 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: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: August 31, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–22132 Filed 9–3–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0436] 

Center for Biologics Evaluation and 

Research eSubmitter Pilot Evaluation 

Program for Blood Establishments 

That Collect Whole Blood and Blood 

Components 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for 

Biologics Evaluation and Research 

(CBER) is announcing an invitation to 

participate in a pilot evaluation program 

for CBER’s eSubmitter Program 

(eSubmitter). CBER’s eSubmitter has 

been customized as an automated 

biologics license application (BLA) and 

BLA supplement (BLS) submission 

system for blood and blood components. 

Participation in the pilot program is 

open to blood establishments that 

collect Whole Blood and blood 

components. The pilot program is 

intended to provide industry and CBER 

regulatory review staff the opportunity 

to evaluate the eSubmitter system and 

determine if it facilitates the BLA/BLS 

submission process. The purpose of this 

notice is to invite blood establishments 

that collect Whole Blood and blood 

components to submit a request to CBER 

if they are interested in participating in 

this pilot program. 

DATES: Submit a written or electronic 

request for participation in this program 

by October 7, 2010. 

ADDRESSES: If you are interested in 

participating in this program, you 

should submit a request to participate in 

the program to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic requests to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Lore 

Fields, Center for Biologics Evaluation 

and Research (HFM–375), Food and 

Drug Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 20852– 

1448, 301–827–6143, FAX: 301–827– 

3534, email: lore.fields@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CBER regulates certain biological 

products, including blood and blood 

products, and is committed to 

advancing the public health through 

innovative activities that help ensure 

the safety, effectiveness and timely 

delivery of these products to patients. 

Further, CBER seeks to continuously 

enhance and update review efficiency 

and quality, and the quality of its 

regulatory efforts and interactions, by 

providing CBER staff and industry with 

improved processes. In support of this 

goal, CBER has participated in the FDA 

development of a computer-assisted 

automated BLA/BLS submission 

program called eSubmitter to improve 

the process for providing certain 

regulatory submissions to FDA. 

eSubmitter will include programs to 

submit applications for licensure, 

supplements to an approved license, 

and amendments to pending 

applications or supplements. 

II. The eSubmitter Pilot Evaluation 

Program Expectations 

The eSubmitter pilot evaluation 

program is expected to last 

approximately 12 months. During this 

period of time, participants will 

complete BLA/BLS regulatory 

submissions using the eSubmitter 

template developed at CBER for use by 

blood establishments that collect Whole 

Blood and blood components. 

eSubmitter was developed using the 

same review criteria for applications for 

these products as currently used in the 

BLA/BLS review process at CBER. 

During the BLA/BLS submission 

process, the participants will enter the 

requested information into the 

eSubmitter tool and attach requested 

documents as an Adobe document (pdf 

format). This information will be saved 

onto a CD–ROM and mailed to CBER for 

review. Paper copies of submissions 

will not be required. CBER will review 

the information provided on the CD– 

ROM and the attachments according to 

current managed review procedures. 

During the BLA/BLS submission 

process, CBER staff will be available to 

answer any questions or concerns that 

may arise. As each submission is 

completed, the users will be asked to 

comment on the eSubmitter program. 

These discussions will assist CBER in 

the final development and release of 

this electronic tool for use by industry. 

III. Requests for Participation 

Requests to participate in the 

eSubmitter pilot are to be identified 

with the docket number found in 

brackets in the heading of this 

document. You should include the 

following information in your request: 

Contact name, contact phone number, 

email address, name of the 

establishment, address, and license 

number. Once requests for participation 

are received, FDA will contact 

interested establishments to discuss the 

pilot program. 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
54344 Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices 

Dated: August 31, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22167 Filed 9–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0048] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EFFIENT 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

EFFIENT 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 electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

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 EFFIENT 

(Prasugrel Hydrochloride). EFFIENT is a 

platelet inhibitor indicated for the 

reduction of thrombotic cardiovascular 

events (including stent thrombosis) in 

patients with acute coronary syndrome 

who are to be managed with 

percutaneous coronary intervention. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

EFFIENT (U.S. Patent No. 5,288,726) 

from Daiichi Sankyo Co. Ltd., and UBE 

Industries, Ltd., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated March 24, 2010, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of EFFIENT 

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 

EFFIENT is 2,795 days. Of this time, 

2,232 days occurred during the testing 

phase of the regulatory review period, 

while 563 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: November 16, 

2001. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on November 16, 2001. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 26, 2007. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

EFFIENT (NDA 22–307) was submitted 

on December 26, 2007. 

3. The date the application was 

approved: July 10, 2009. FDA has 

verified the applicant’s claim that NDA 

22–307 was approved on July 10, 2009. 

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 1,679 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) either 

electronic or written comments and ask 

for a redetermination by November 8, 

2010. 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 7, 2011. 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. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

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

through Friday. 

Dated: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–22234 Filed 9–3–10; 8:45 am] 

BILLING CODE 4160–01–S 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1