Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices 15321 

1Communications regarding procedural matters 

between the Office of the Commissioner and the 

advisory committee will not be treated as ex parte 

communications. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0176] 

SEDASYS Computer-Assisted 

Personalized Sedation System; 

Ethicon Endo-Surgery, Inc.’s, Petition 

for Review of FDA’s Denial of 

Premarket Approval 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that it intends to refer for review before 

an advisory committee Ethicon EndoSurgery Inc.’s (EES’s), petition for 

review of the Agency’s denial of 

premarket approval for its SEDASYS 

computer-assisted personalized sedation 

system (SEDASYS system). 

ADDRESSES: Submissions related to the 

petition should be filed with the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Tarita Rooths, Regulations, Policy, and 

Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–9138. 

SUPPLEMENTARY INFORMATION: On 

February 26, 2010, the Center for 

Devices and Radiological Health (CDRH) 

issued a not approvable letter in 

response to the premarket approval 

application (PMA) (PMA P080009) 

submitted by EES for the SEDASYS 

system. The SEDASYS system is 

intended for use by gastroenterologists 

as a drug-delivery system for the 

administration of propofol for minimalto-moderate sedation in healthy patients 

undergoing a colonoscopy or 

esophagogastroduodenoscopy. CDRH 

determined the PMA for the SEDASYS 

system not to be approvable under 

§ 814.44(f) (21 CFR 814.44(f)) because it 

concluded that the data and information 

offered in support of the PMA did not 

provide a reasonable assurance that the 

device is safe under the conditions of 

use prescribed, recommended, or 

suggested in the proposed labeling, as 

required by section 515(d)(2)(A) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act). 

On March 25, 2010, EES requested 

administrative review of the not 

approvable letter. Submitted in the form 

of a petition for reconsideration under 

21 CFR 10.33 (see § 814.44(f)(2)), EES’s 

request stated that, in accordance with 

§ 814.44(f), EES considered the not 

approvable letter to be a denial of 

approval of PMA P080009 under 

§ 814.45 (21 CFR 814.45). Pursuant to 

section 515(d)(4) of the FD&C Act, EES 

requested review of this denial under 

section 515(g)(2) (21 U.S.C. 360e(g)(2)) 

of the FD&C Act. 

Accordingly, as required by 

§ 814.45(e)(3), CDRH issued an order 

denying approval of the PMA for the 

SEDASYS system on October 26, 2010 

(Ref. 1). Pursuant to section 515(g)(2) of 

the FD&C Act, on November 5, 2010, 

FDA granted EES’s petition for review of 

the order denying PMA P080009. 

In accordance with section 515(g)(2) 

of the FD&C Act, the Commissioner of 

Food and Drugs (the Commissioner) or 

her designee is referring PMA P080009 

and the basis for the order denying its 

approval to an advisory committee of 

qualified experts. After independent 

study of the data and information 

furnished by the parties, and other data 

and information before it, the advisory 

committee will submit to the 

Commissioner a report and 

recommendation with respect to the 

order, together with the underlying data 

and information and a statement of the 

reasons or basis for the recommendation 

(section 515(g)(2)(A) of the FD&C Act). 

The Commissioner will provide a copy 

of that report and recommendation to 

the petitioner (id.), as well as to CDRH. 

At this time, the Commissioner also 

anticipates offering both the petitioner 

and CDRH the opportunity to submit 

comments on the report and 

recommendation before the final order 

is rendered. In keeping with section 

515(g)(2)(C) of the FD&C Act, the 

Commissioner will make the report and 

recommendation public and issue an 

order either affirming or reversing the 

denial of approval. 

In 1999, FDA established a standing 

advisory committee known as the 

Medical Devices Dispute Resolution 

Panel to provide advice to the 

Commissioner on complex or contested 

scientific issues between FDA and 

medical device sponsors, applicants, or 

manufacturers relating to specific 

products, marketing applications, 

regulatory decisions and actions by 

FDA, and Agency guidance and policies 

(see the charter for the Medical Devices 

Advisory Committee (MDAC charter)) 

(Ref. 2). In a guidance document 

entitled ‘‘Resolving Scientific Disputes 

Concerning the Regulation of Medical 

Devices, A Guide to Use of the Medical 

Devices Dispute Resolution Panel’’ (July 

2, 2001) (the Guidance), FDA clarified 

that the Medical Devices Dispute 

Resolution Panel was established, in 

part, to receive referrals of petitions for 

advisory committee review under 

section 515(g)(2) of the FD&C Act (Ref. 

3). 

Accordingly, the Commissioner will 

refer EES’s petition for review to this 

advisory committee for a report and 

recommendation with respect to the 

order denying PMA P080009. The Office 

of the Commissioner will select the 

temporary members of, and any 

consultants to, the advisory committee, 

and otherwise ensure that the 

proceeding is conducted in accordance 

with section 515(g)(2) of the FD&C Act, 

the Federal Advisory Committee Act, 

FDA’s regulations in 21 CFR part 14 

governing its public advisory 

committees, the MDAC charter, and any 

other applicable laws or regulations. 

The Office of the Commissioner will 

also perform the other duties assigned to 

FDA under section 515(g)(2) of the 

FD&C Act. The Office of the 

Commissioner will publish a Federal 

Register notice concerning the advisory 

committee meeting at a later date. 

Although no statute or regulation 

requires that separation of functions be 

applied to this proceeding, the Agency 

is observing separation of functions as a 

matter of policy in this matter. As the 

Center responsible for the action under 

review, CDRH will be, like EES, a party 

to the advisory committee hearing and 

will be responsible for presenting its 

position at that meeting. 

In addition, as a corollary to its 

decision to observe a separation of 

functions, until the Commissioner 

issues an order either affirming or 

reversing the order denying approval of 

PMA P080009, the Office of the 

Commissioner will not engage in any ex 

parte communication (see 21 CFR 

10.3(a)) with anyone participating as a 

party to the hearing or any person 

outside the Agency with respect to the 

matter under consideration.1 Any 

written ex parte communication will be 

immediately served on the two parties 

and filed in the docket. Any oral ex 

parte communication will be 

immediately memorialized in writing, 

served on both parties to the hearing, 

and filed in the docket. 

All documents filed in this matter are 

filed under Docket No. FDA–2010–P– 

0176 and are available for public review 

in the Division of Dockets Management 

(see ADDRESSES) between 9 a.m. and 4 

p.m., Monday through Friday. Persons 

with access to the Internet may obtain 

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15322 Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices 

documents in the docket at http:// 

www.regulations.gov. 

References 

The following references are on 

display in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20857, under 

Docket No. FDA–2010–P–0176 and may 

be seen by interested persons between 9 

a.m. and 4 p.m., Monday through 

Friday. 

1. Letter from Christy Foreman, FDA, 

CDRH, to Ken Charak, Ethicon EndoSurgery, Inc., containing the order 

denying approval of the PMA for the 

SEDASYS system, October 26, 2010. 

2. Charter Medical Devices Advisory 

Committee; Charter Amendment, 

Medical Devices Advisory Committee; 

FDA; July 15, 2008, http://www.fda.gov/ 

AdvisoryCommittees/Committees

MeetingMaterials/MedicalDevices/

MedicalDevicesAdvisoryCommittee/

ucm124098.htm. 

3. ‘‘Resolving Scientific Disputes 

Concerning the Regulation of Medical 

Devices, A Guide To Use of the Medical 

Devices Dispute Resolution Panel; Final 

Guidance for Industry and FDA’’ FDA, 

CDRH; July 2, 2001, http://www.fda.gov/ 

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/

default.htm. 

Dated: March 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6520 Filed 3–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0400] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; VPRIV 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for VPRIV 

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 (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 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 VPRIV 

(velaglucerase alfa). VPRIV is indicated 

for long-term enzyme replacement 

therapy for pediatric and adult patients 

with type 1 Gaucher Disease. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for VPRIV 

(U.S. Patent No. 7,138,262) from Shire 

Human Genetic Therapies, Inc., 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 

30, 2010, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

VPRIV 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 

VPRIV is 2,221 days. Of this time, 2,041 

days occurred during the testing phase 

of the regulatory review period, while 

180 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 FD&C Act) (21 

U.S.C. 355(i)) became effective: January 

30, 2004. The applicant claims May 20, 

2004, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was January 30, 2004, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: August 31, 

2009. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for VPRIV (NDA 22–575) was 

initially submitted on August 31, 2009. 

3. The date the application was 

approved: February 26, 2010. FDA has 

verified the applicant’s claim that NDA 

22–575 was approved on February 26, 

2010. 

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 687 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 20, 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 19, 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. 

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