SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition for Review of FDA's Denial of Premarket Approval, 15321-15322 [2011-6520]

Download as PDF Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices 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. 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 mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:50 Mar 18, 2011 Jkt 223001 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 15321 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 1 Communications regarding procedural matters between the Office of the Commissioner and the advisory committee will not be treated as ex parte communications. E:\FR\FM\21MRN1.SGM 21MRN1 15322 Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices documents in the docket at https:// 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, https://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, https://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. 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 https:// mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:50 Mar 18, 2011 Jkt 223001 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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. E:\FR\FM\21MRN1.SGM 21MRN1

Agencies

[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Notices]
[Pages 15321-15322]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6520]



[[Page 15321]]

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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 Endo-
Surgery 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 minimal-to-moderate sedation in healthy 
patients undergoing a colonoscopy or esophagogastroduodenoscopy. CDRH 
determined the PMA for the SEDASYS system not to be approvable under 
Sec.  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 Sec.  814.44(f)(2)), EES's 
request stated that, in accordance with Sec.  814.44(f), EES considered 
the not approvable letter to be a denial of approval of PMA P080009 
under Sec.  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 Sec.  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.
---------------------------------------------------------------------------

    \1\ Communications regarding procedural matters between the 
Office of the Commissioner and the advisory committee will not be 
treated as ex parte communications.
---------------------------------------------------------------------------

    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

[[Page 15322]]

documents in the docket at https://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 
Endo-Surgery, 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, https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/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, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/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

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