Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 12975 

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 http://

www.regulations.gov may be viewed in 

the Division of Dockets Management 

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

through Friday. 

Dated: February 14, 2011. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2011–5312 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0332] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CERVARIX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

CERVARIX 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 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 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 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 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 biological product 

CERVARIX (human papillomavirus 

bivalent (types 16 and 18) vaccine). 

CERVARIX is indicated for prevention 

of the following diseases caused by 

oncogenic human papillomavirus types 

16 and 18: cervical cancer; cervical 

intraepithelial neoplasia grade 2 or sores 

and adenocarcinoma in situ; and 

cervical intraepithelial neoplasia grade 

1. Subsequent to this approval, the 

Patent and Trademark Office received a 

patent term restoration application for 

CERVARIX (U.S. Patent No. 7,351,533) 

from MedImmune, LLC., and the Patent 

and Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated October 26, 2010, FDA 

advised the Patent and Trademark 

Office that this human biological 

product had undergone a regulatory 

review period and that the approval of 

CERVARIX 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 

CERVARIX is 4,027 days. Of this time, 

3,094 days occurred during the testing 

phase of the regulatory review period, 

while 933 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: October 9, 1998. The 

applicant claims September 8, 1998, as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was October 9, 1998, 

which was 30 days after FDA receipt of 

the IND. 

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): March 29, 2007. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

CERVARIX (BLA 125259/0) was 

submitted on March 29, 2007. 

3. The date the application was 

approved: October 16, 2009. FDA has 

verified the applicant’s claim that BLA 

125259/0 was approved on October 16, 

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 562 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 May 9, 2011. 

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 

September 5, 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 


Emcdonald on DSK2BSOYB1PROD with NOTICES
12976 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 

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 

http://www.regulations.gov may be 

viewed in the Division of Dockets 

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

Monday through Friday. 

Dated: February 14, 2011. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2011–5310 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance 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. 

Proposed Project: Supplemental 

Information Request for the Submission 

of the Updated State Plan for the Home 

Visiting Program (OMB No. 0915– 

0336)—[Extension] 

On March 23, 2010, the President 

signed into law the Patient Protection 

and Affordable Care Act of 2010 (Pub. 

L. 111–148), historic and transformative 

legislation designed to make quality, 

affordable health care available to all 

Americans, reduce costs, improve 

health care quality, enhance disease 

prevention, and strengthen the health 

care workforce. Through a provision 

authorizing the creation of the Maternal, 

Infant, and Early Childhood Home 

Visiting Program, (http://frwebgate.

access.gpo.gov/cgi-bin/

getdoc.cgi?dbname=111_cong_bills&

docid=f:h3590enr.txt.pdf, pages 216– 

225), the Act responds to the diverse 

needs of children and families in 

communities at risk and provides an 

unprecedented opportunity for 

collaboration and partnership at the 

Federal, State, and community levels to 

improve health and development 

outcomes for at-risk children through 

evidence-based home visiting programs. 

The Maternal, Infant, and Early 

Childhood Home Visiting (MIECHV) 

Program is designed: (1) To strengthen 

and improve the programs and activities 

carried out under Title V; (2) to improve 

coordination of services for at-risk 

communities; and (3) to identify and 

provide comprehensive services to 

improve outcomes for families who 

reside in at-risk communities. 

To achieve the legislative 

requirements of the MIECHV program, 

the following application steps were 

required: 

The first step was submission of an 

application for funding: the Funding 

Opportunity Announcement (FOA) 

HRSA–10–275 was issued on June 10, 

2010, and State applications were due 

July 9, 2010. These applications were to 

include plans for completing the 

statewide needs assessment and initial 

State plans for developing the program 

in order to meet the criteria identified 

in the legislation. Submission of the 

needs assessments in the form and 

manner required by the Secretary is also 

a required condition for States to receive 

FY 2011 Title V Block Grant allotments. 

On September 20, 2010, all 50 States, 

the District of Columbia, and five U.S. 

territories submitted needs assessments 

that identified communities at risk. The 

needs assessments submitted were 

approved, and all 56 applicants have 

received FY 2011 Title V Block Grant 

funds. 

As a condition of receiving the 

remaining grant award made to States in 

July 2010, each of the 56 applicants is 

also required to develop an Updated 

State Plan for a State Home Visiting 

Program. The Secretary of Health and 

Human Services must approve the 

Updated State Plan before the release of 

the remaining grant funds. 

The information requested for the 

Updated State Plan is intended to help 

States view their proposed State Home 

Visiting Program as a service strategy 

aimed at developing a comprehensive, 

high-quality early childhood system that 

promotes maternal, infant, and early 

childhood health, safety and 

development, and strong parent-child 

relationships in the targeted 

community(ies) at risk. Ultimately, the 

information provided will help States 

develop a comprehensive plan that 

addresses community risk factors, 

builds on strengths identified in the 

targeted community(ies), and responds 

to the specific characteristics and needs 

of families in each of these 

communities. 

The annual estimate of burden is as 

follows: 

Instrument Number of 

respondents 

Responses 

per respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Section 1: Identification of the State’s Targeted At-Risk 

Community(ies) ................................................................ 56 1 56 30 1,680 

Section 2: State Home Visiting Program Goals and Objectives .................................................................................. 56 1 56 30 1,680 

Section 3: Selection of Proposed Home Visiting Model(s) 

and Explanation of How the Model(s) Meet the Needs of 

Targeted Community(ies) ................................................. 56 1 56 30 1,680 

Section 4: Implementation Plan for Proposed State Home 

Visiting Program ............................................................... 56 1 56 60 3,360 


Emcdonald on DSK2BSOYB1PROD with NOTICES