Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 10055 

FDA estimates that approximately 250 

respondents will participate in this 

voluntary survey. These respondents 

will consist mostly of other Federal 

agencies, health plan data sources, 

health information exchanges, large 

multi-specialty medical groups and 

academic medical centers, large hospital 

systems, pharmacies, medical societies, 

consumer-oriented Web sites, 

commercial data sets, research 

networks, lab data, and registries. 

Each respondent will extend 

approximately 24.5 hours to complete 1 

survey for a total of 6,125 hours (250 x 

1 x 24.5 = 6,125). 

Dated: February 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4830 Filed 3–6–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–E–0164] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ALTABAX OINTMENT 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ALTABAX OINTMENT 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 ALTABAX 

OINTMENT (retapamulin). ALTABAX 

OINTMENT is indicated for the topical 

treatment of impetigo due to 

Staphylococcus aureus (methicillinsusceptible isolates only) or 

Streptococcus pyogenes in patients aged 

9 months or older. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for ALTABAX OINTMENT 

(U.S. Patent No. RE39,128E) from 

SmithKline Beecham P.L.C., and 

SmithKline Beecham Corp., and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated April 28, 

2008, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

ALTABAX OINTMENT 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 

ALTABAX OINTMENT is 1,602 days. 

Of this time, 1,297 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 (the act) (21 U.S.C. 

355(i)) became effective: November 24, 

2002. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on November 24, 2002. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: June 12, 2006. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

ALTABAX OINTMENT (NDA 22–055) 

was initially submitted on June 12, 

2006. 

3. The date the application was 

approved: April 12, 2007. FDA has 

verified the applicant’s claim that NDA 

22–055 was approved on April 12, 2007. 

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 833 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 May 8, 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 

September 8, 2009. 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 

document. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday. 


dwashington3 on PROD1PC60 with NOTICES
10056 Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 

Dated: February 17, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–4914 Filed 3–6–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Council on Blood Stem Cell 

Transplantation; Request for 

Nominations for Voting Members 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

requesting nominations to fill expected 

vacancies on the Advisory Council on 

Blood Stem Cell Transplantation. 

The Advisory Council on Blood Stem 

Cell Transplantation was established 

pursuant to Public Law 109–129, 42 

U.S.C. 274k (section 379 of the Public 

Health Service Act, as amended). In 

accordance with Public Law 92–463, the 

Council was chartered on December 19, 

2006. 

DATES: The agency must receive 

nominations on or before April 8, 2009. 

ADDRESSES: All nominations should be 

submitted to the Executive Secretary, 

Advisory Council on Blood Stem Cell 

Transplantation, Healthcare Systems 

Bureau, HRSA, Parklawn Building, 

Room 12–105, 5600 Fishers Lane, 

Rockville, Maryland 20857. Federal 

Express, Airborne, or UPS, mail delivery 

should be addressed to Executive 

Secretary, Advisory Council on Blood 

Stem Cell Transplantation, Healthcare 

Systems Bureau, HRSA, at the above 

address. 

FOR FURTHER INFORMATION CONTACT: 

Remy Aronoff, Executive Secretary, 

Advisory Council on Blood Stem Cell 

Transplantation, at (301) 443–3264 or email Remy.Aronoff@hrsa.hhs.gov or 

Robert Baitty, Director, Blood Stem Cell 

Transplantation Program, Division of 

Transplantation, at (301) 443–2612 or email Robert.Baitty@hrsa.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Council was established to implement a 

statutory requirement of the Stem Cell 

Therapeutic and Research Act of 2005 

(Pub. L. 109–129). The Council is 

governed by the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

Appendix 2), which sets forth standards 

for the formation and use of advisory 

committees. 

The Advisory Council advises the 

Secretary and the Administrator, HRSA, 

on matters related to the activities of the 

C.W. Bill Young Cell Transplantation 

Program and the National Cord Blood 

Inventory Program. 

The Council shall, as requested by the 

Secretary, discuss and make 

recommendations regarding the C.W. 

Bill Young Cell Transplantation 

Program (Program). It shall provide a 

consolidated, comprehensive source of 

expert, unbiased analysis and 

recommendations to the Secretary on 

the latest advances in the science of 

blood stem cell transplantation. The 

Council shall advise, assist, consult and 

make recommendations, at the request 

of the Secretary, on broad Program 

policy in areas such as the necessary 

size and composition of the adult donor 

pool available through the Program and 

the composition of the National Cord 

Blood Inventory, requirements regarding 

informed consent for cord blood 

donation, accreditation requirements for 

cord blood banks, the scientific factors 

that define a cord blood unit as high 

quality, public and professional 

education to encourage the ethical 

recruitment of genetically diverse 

donors and ethical donation practices, 

criteria for selecting the appropriate 

blood stem source for transplantation, 

Program priorities, research priorities, 

and the scope and design of the Stem 

Cell Therapeutic Outcomes Database. It 

also shall, at the request of the 

Secretary, review and advise on issues 

relating more broadly to the field of 

blood stem cell transplantation, such as 

regulatory policy including 

compatibility of international 

regulations, and actions that may be 

taken by the State and Federal 

Governments and public and private 

insurers to increase donation and access 

to transplantation. The Advisory 

Council also shall make 

recommendations regarding research on 

emerging therapies using cells from 

bone marrow and cord blood. 

The Council consists of up to 25 

members, including the Chair. Members 

of the Advisory Council shall be chosen 

to ensure objectivity and balance, and 

reduce the potential for conflicts of 

interest. The Secretary shall establish 

bylaws and procedures to prohibit any 

member of the Advisory Council who 

has an employment, governance, or 

financial affiliation with a donor center, 

recruitment organization, transplant 

center, or cord blood bank from 

participating in any decision that 

materially affects the center, recruitment 

organization, transplant center, or cord 

blood bank; and to limit the number of 

members of the Advisory Council with 

any such affiliation. 

The members and Chair shall be 

selected by the Secretary from 

outstanding authorities and 

representatives of marrow donor centers 

and marrow transplant centers; 

representatives of cord blood banks and 

participating birthing hospitals; 

recipients of a bone marrow transplant; 

recipients of a cord blood transplant; 

persons who require such transplants; 

family members of such a recipient or 

family members of a patient who has 

requested the assistance of the Program 

in searching for an unrelated donor of 

bone marrow or cord blood; persons 

with expertise in bone marrow and cord 

blood transplantation; persons with 

expertise in typing, matching, and 

transplant outcome data analysis; 

persons with expertise in the social 

sciences; basic scientists with expertise 

in the biology of adult stem cells; 

ethicists, hematology and transfusion 

medicine researchers with expertise in 

adult blood stem cells; persons with 

expertise in cord blood processing; and 

members of the general public. 

In addition, representatives from the 

Division of Transplantation of the 

Health Resources and Services 

Administration, the Department of 

Defense Marrow Recruitment and 

Research Program operated by the 

Department of the Navy, the Food and 

Drug Administration, the National 

Institutes of Health, the Centers for 

Medicare & Medicaid Services, and the 

Centers for Disease Control and 

Prevention serve as non-voting ex officio 

members. 

Specifically, HRSA is requesting 

nominations for voting members of the 

Advisory Council on Blood Stem Cell 

Transplantation in these categories: 

Marrow donor centers and transplant 

centers representatives; cord blood 

banks and participating hospitals 

representatives; family members of bone 

marrow transplant and cord blood 

transplant recipients or family members 

of a patient who has requested 

assistance by the Program in searching 

for an unrelated donor; persons with 

expertise in bone marrow or cord blood 

transplantation; persons with expertise 

in typing, matching, and transplant 

outcome data analysis; basic scientists 

with expertise in the biology of adult 

stem cells; researchers in hematology 

and transfusion medicine with expertise 

in adult blood stem cells; persons with 

expertise in cord blood processing; and 

members of the general public. 

Nominees will be invited to serve a 2- 

to 6-year term beginning after January 1, 

2010. 


dwashington3 on PROD1PC60 with NOTICES