Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 9227 

donors. Section 1270.33(f) requires 

records to be retained regarding the 

determination of the suitability of the 

donors and such records required under 

§ 1270.21. Section 1270.33(h) requires 

all records to be retained at least 10 

years beyond the date of transplantation 

if known, distribution, disposition, or 

expiration of the tissue, whichever is 

the latest. Section 1270.35(a) through (d) 

requires specific records to be 

maintained to document the following: 

(1) The results and interpretation of all 

required infectious disease tests, (2) 

information on the identity and relevant 

medical records of the donor, (3) the 

receipt and/or distribution of human 

tissue, and (4) the destruction or other 

disposition of human tissue. 

Respondents to this collection of 

information are manufacturers of human 

tissue intended for transplantation. 

Based on information from the Center 

for Biologics Evaluation and Research’s 

(CBER’s) database system, FDA 

estimates that there are approximately 

257 tissue establishments of which 145 

are conventional tissue banks and 112 

are eye tissue banks. Based on 

information provided by industry, there 

are an estimated total of 1,959,270 

conventional tissue products and 82,741 

eye tissue products recovered per year 

with an average of 25 percent of the 

tissue discarded due to unsuitability for 

transplant. In addition, there are an 

estimated 57,275 donors of conventional 

tissue and 54,115 donors of eye tissue 

each year. 

Accredited members of the American 

Association of Tissue Banks (AATB) 

and Eye Bank Association of America 

(EBAA) adhere to standards of those 

organizations that are comparable to the 

recordkeeping requirements in part 

1270. Based on information provided by 

CBER’s database system, 90 percent of 

the conventional tissue banks are 

members of AATB (145 x 90% = 130), 

and 77 percent of eye tissue banks are 

members of EBAA (112 x 77% = 86). 

Therefore, recordkeeping by these 216 

establishments (130 + 86 = 216) is 

excluded from the burden estimates as 

usual and customary business activities 

(5 CFR 1320.3(b)(2)). The recordkeeping 

burden, thus, is estimated for the 

remaining 41 establishments, which is 

16 percent of all establishments (257 - 

216 = 41, or 41/257 = 16%). 

FDA assumes that all current tissue 

establishments have developed written 

procedures in compliance with part 

1270. Therefore, their information 

collection burden is for the general 

review and update of written 

procedures estimated to take an annual 

average of 24 hours, and for the 

recording and justifying of any 

deviations from the written procedures 

for § 1270.31(a) and (b), estimated to 

take an annual average of 1 hour. The 

information collection burden for 

maintaining records concurrently with 

the performance of each significant 

screening and testing step and for 

retaining records for 10 years under 

§ 1270.33(a), (f), and (h), include 

documenting the results and 

interpretation of all required infectious 

disease tests and results and the identity 

and relevant medical records of the 

donor required under § 1270.35(a) and 

(b). Therefore, the burden under these 

provisions is calculated together in table 

1 of this document. The recordkeeping 

estimates for the number of total annual 

records and hours per record are based 

on information provided by industry 

and FDA experience. 

FDA estimates the burden of this 

information collection as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Response Total Hours 

1270.31(a), (b), (c), and (d)2 41 1 41 24 984 

1270.31(a) and (b)3 41 2 82 1 82 

1270.33(a), (f), and (h) and 

1270.35(a) and (b) 41 8,404 344,564 1 344,564 

1270.35(c) 41 15,938 653,458 1 653,458 

1270.35(d) 41 1,992 81,672 1 81,672 

Total 1,080,760 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Review and update of SOPs. 

3 Documentation of deviations from SOPs. 

Dated: February 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4066 Filed 2–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0206] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; FIRMAGON 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

FIRMAGON 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

9228 Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 

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 FIRMAGON 

(degarelix acetate). FIRMAGON is 

indicated for treatment of patients with 

advanced prostate cancer. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for FIRMAGON (U.S. Patent 

No. 5,925,730) from Ferring BV, and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated September 

29, 2009, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

FIRMAGON 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 

FIRMAGON is 2,695 days. Of this time, 

2,394 days occurred during the testing 

phase of the regulatory review period, 

while 301 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: August 10, 

2001. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on August 10, 2001. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: February 28, 2008. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) 

22–201 was submitted on February 28, 

2008. 

3. The date the application was 

approved: December 24, 2008. FDA has 

verified the applicant’s claim that NDA 

22–201 was approved on December 24, 

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 1,498 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 April 30, 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 

August 30, 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 

document. 

Comments and petitions may be seen 

in the Division of Dockets Management 

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

through Friday. 

Dated: February 9, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–4159 Filed 2–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0075] 

Draft Guidance for Industry on NonInferiority Clinical Trials; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Non-Inferiority 

Clinical Trials.’’ This draft guidance 

provides sponsors and review staff in 

the Center for Drug Evaluation and 

Research (CDER) and the Center for 

Biologics Evaluation and Research 

(CBER) with the agency’s interpretation 

of the underlying principles involved in 

the use of non-inferiority (NI) study 

designs to provide evidence of the 

effectiveness of a drug or therapeutic 

biologic product. The draft guidance 

offers advice on when NI studies can be 

interpretable, how to choose the NI 

margin, and how to analyze the results. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by June 1, 2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002, or to the 

Office of Communication, Outreach and 

Development, 1401 Rockville Pike, suite 

200N, Rockville, MD 20852–1448. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

mstockstill on DSKH9S0YB1PROD with NOTICES