Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 32479 

additional information regarding the 

device necessary for FDA to file the 

PMA or to complete its review and 

make a final decision. The PMA 

applicant may, also on their own 

initiative, submit additional information 

to FDA during the review process. 

These amendments contain information 

ranging from additional test results, reanalysis of the original data set to 

revised device labeling. Almost all 

PMAs received by the Agency have 

amendments submitted during the 

review process. FDA estimates that 

6,012 burden hours are necessary to 

satisfy this requirement. 

• PMA Supplements in § 814.39(a) 

FDA believes that the amendments 

mandated by FDAMA for § 814.39(f), 

permitting the submission of the 30-day 

notices in lieu of regular PMA 

supplements, will result in an 

approximate 20 percent reduction in the 

total number of hours as compared to 

regular PMA supplements. As a result, 

FDA estimates that 40,200 hours of 

burden are needed to complete the 

requirements for regular PMA 

supplements. 

• Special PMA Supplements— 

Changes Being Affected in § 814.39(d) 

These types of supplements are 

intended to enhance the safety of the 

device or the safe use of the device. The 

number of PMA supplements received 

that fit this category averaged 68 per 

year based on the numbers received 

from FY 2005 through FY 2009. Because 

of the minimal data required to be 

included in this type of supplement, 

FDA estimates that the burden hours 

necessary to satisfy this requirement are 

408 hours. 

• 30–Day Notice in § 814.39(f) 

Under section 515(d) of the act, 

modifications to manufacturing 

procedures or methods of manufacture 

that affect the safety and effectiveness of 

a device subject to an approved PMA do 

not require submission of a PMA 

supplement under § 814.39(a) and are 

eligible to be the subject of a 30-day 

notice. A 30-day notice shall describe in 

detail the change, summarize the data or 

information supporting the change, and 

state that the change has been made in 

accordance with the requirements of 

part 820 (21 CFR part 820). The 

manufacturer may distribute the device 

30 days after the date on which FDA 

receives the 30-day notice, unless FDA 

notifies the applicant within 30 days 

from receipt of the notice, that it is not 

adequate. FDA estimates the burden to 

satisfy this requirement is 8,080 hours. 

• Post-Approval Requirements in 

§ 814.82(a)(9) 

Post-approval requirements concern 

approved PMAs that were not 

reclassified and require a periodic 

report. After approval, all PMAs require 

a submission of an annual report. On 

average, approximately half of the 

submitted PMAs (18), require associated 

post-approval studies, i.e., followup of 

patients used in clinical trials to support 

the PMA or additional preclinical 

information, that is labor-intensive to 

compile and complete; the remaining 

PMAs require minimal information. 

Based on experience and consultation 

with industry, FDA has estimated that 

preparation of reports and information 

required by this section requires 2,430 

hours. 

• Reports in § 814.84(b) 

Post-approval requirements described 

in § 814.82(a)(7) require submission of 

an annual report for each approved 

PMA. FDA estimates that respondents 

will average about 10 hours in preparing 

their reports to meet this requirement. 

This estimate is based on FDA’s 

experience and consultation with 

industry. Thus, FDA estimates that the 

periodic reporting burden required by 

this section will take 6,480 hours. 

Statutory Reporting Burden Estimate 

(FDAMA) 

The total statutory reporting burden 

under the requirements of sections 201, 

202, 205, 208, and 209 of FDAMA is 

estimated to be 1,230 hours. This 

burden estimate was based on actual 

real and estimated FDA data tracked 

from FY 2005 through FY 2009, and an 

estimate was also derived to forecast 

future expectations with regard to this 

statutory data. 

Recordkeeping in § 814.82(a)(5) and 

(a)(6) 

The recordkeeping burden under this 

section requires the maintenance of 

records, used to trace patients and the 

organization and the indexing of records 

into identifiable files to ensure the 

device’s continued safety and 

effectiveness. These records are required 

only of those manufacturers who have 

an approved PMA and who had original 

clinical research in support of that 

PMA. For a typical year’s submissions, 

70 percent of the PMAs are eventually 

approved with 90 percent of these 

having original clinical trial data. 

Therefore, approximately 25 PMAs a 

year would be subject to these 

requirements. Also, because the 

requirements apply to all active PMAs, 

all holders of an active PMA application 

must maintain these records. 

PMAs have been required since 1976, 

and there are 698 active PMAs that 

could be subject to these requirements, 

based on actual FDA data. Each study 

has approximately 200 subjects, and at 

an average of 5 minutes per subject, 

there is a total burden per study of 1,000 

minutes, or 17 hours. The aggregate 

burden for all 698 holders of approved 

original PMAs, therefore, is 11,866 

hours. 

The applicant determines which 

records should be maintained during 

product development to document and/ 

or substantiate the device’s safety and 

effectiveness. Records required by the 

current good manufacturing practices 

for medical devices regulation (part 820) 

may be relevant to a PMA review and 

may be submitted as part of an 

application. In individual instances, 

records may be required as conditions of 

approval to ensure the device’s 

continuing safety and effectiveness. 

Dated: June 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13763 Filed 6–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–E–0165 and FDA– 

2009–E–0169] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ABLAVAR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ABLAVAR (previously the trade name 

of the product was VASOVIST) and is 

publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of applications to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims the 

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. 


emcdonald on DSK2BSOYB1PROD with NOTICES
32480 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 

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 ABLAVAR 

(gadofosveset trisodium). ABLAVAR is 

indicated for use as a contrast agent in 

magnetic resonance angiography to 

evaluate aortoiliac occlusive disease in 

adults with known or suspected 

peripheral vascular disease. Subsequent 

to this approval, the Patent and 

Trademark Office received patent term 

restoration applications for ABLAVAR 

(U.S. Patent Nos. 6,676,929 and 

7,060,250) from Epix Pharmaceuticals, 

Inc., and the Patent and Trademark 

Office requested FDA’s assistance in 

determining the patents’ 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 ABLAVAR 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 

ABLAVAR is 4,508 days. Of this time, 

2,673 days occurred during the testing 

phase of the regulatory review period, 

while 1,835 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 21, 

1996. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on August 21, 1996. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 15, 2003. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) 

21–711 was submitted on December 15, 

2003. 

3. The date the application was 

approved: December 22, 2008. FDA has 

verified the applicant’s claim that NDA 

21–711 was approved on December 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 applications for patent extension, 

this applicant seeks 1,806 days of patent 

term extension for U.S. Patent No. 

6,676,929 and 924 days of patent term 

extension for U.S. Patent No. 7,060,250. 

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 August 9, 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 

December 6, 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: April 23, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–13655 Filed 6–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration on Aging 

Funding Opportunity: Affordable Care 

Act Medicare Beneficiary Outreach and 

Assistance Program Funding for Title 

VI Native American Programs 

Purpose of Notice: Availability of 

funding opportunity announcement. 

Funding Opportunity Title/Program 

Name: Affordable Care Act Medicare 

Beneficiary Outreach and Assistance 

Program Funding for Title VI Native 

American Programs. 

Announcement Type: Initial. 

Funding Opportunity Number: HHS– 

2010–AoA–MI–1022. 

Statutory Authority: The Medicare 

Improvements for Patients and 

Providers Act of 2008—Section 119, 

Public Law 110–275 as amended by the 

Patient Protection and Affordable Care 

Act of 2010 (Affordable Care Act). 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.071. 

Discretionary Projects 

DATES: The deadline date for the 

submission of applications is July 30, 

2010. 

I. Funding Opportunity Description 

AoA will provide a grant of $1,000 to 

each Older Americans Act Title VI 

Native American program awardee. The 

purpose of these grants will be for the 

coordination of at least one community 

announcement and at least one outreach 

event to inform and assist eligible 

Native American elders about the 

benefits available to them through 

Medicare Part D, the Low Income 

Subsidy, the Medicare Savings Program, 

or Medicare prevention benefits and 

screenings. The example of $1,000 per 

event is for illustrative purposes only. 

There is data available from the 

National Association of Area Agencies 

on Aging (n4a) and studies performed 

by the National Council on Aging 

(NCOA) that reflect these costs for 

planning and implementing a 

community event for Medicare Part D 

and LIS outreach activities. 

A detailed description of the funding 

opportunity may be found at http:// 


emcdonald on DSK2BSOYB1PROD with NOTICES