Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant, 34389-34390 [2012-14000]

Download as PDF Federal Register / Vol. 77, No. 112 / Monday, June 11, 2012 / Notices period by December 10, 2012. 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. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 29, 2012. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2012–14003 Filed 6–8–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–E–0399] Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for Progel Pleural Air Leak Sealant 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 medical device. ADDRESSES: Submit electronic comments to https:// 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. srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:21 Jun 08, 2012 Jkt 226001 FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6284, 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. 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 (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 medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA recently approved for marketing the medical device, Progel Pleural Air Leak Sealant. Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (≥2 mm) incurred during open resection of lung parenchyma. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for Progel Pleural Air Leak Sealant (U.S. Patent No. RE38158) from Neomend, 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 June 8, 2011, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 34389 approval of Progel Pleural Air Leak Sealant represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that the FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for Progel Pleural Air Leak Sealant is 3,854 days. Of this time, 787 days occurred during the testing phase of the regulatory review period, while 3067 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: June 29, 1999. FDA has verified the applicant’s claim that the date the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective June 29, 1999. 2. The date an application was initially submitted with respect to the device under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e): August 23, 2001. FDA has verified the applicant’s claim that the premarket approval application (PMA) for Progel Pleural Air Leak Sealant (PMA P010047) was initially submitted August 23, 2001. 3. The date the application was approved: January 14, 2010. FDA has verified the applicant’s claim that PMA P010047 was approved on January 14, 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 5 years 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 August 10, 2012. 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 10, 2012. 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\11JNN1.SGM 11JNN1 34390 Federal Register / Vol. 77, No. 112 / Monday, June 11, 2012 / Notices Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 29, 2012. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2012–14000 Filed 6–8–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0307] Draft Guidance for Industry: Amendment to ‘‘Guidance for Industry: Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products,’’ Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Amendment (revisions to labeling recommendations for potential risk of vCJD) to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant CreutzfeldtJakob Disease (vCJD) by Blood and Blood Products’ ’’ dated June 2012. The draft guidance document proposes amendments to the labeling recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in the guidance document entitled ‘‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products’’ dated May 2010 (2010 CJD/vCJD guidance). srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:21 Jun 08, 2012 Jkt 226001 When finalized, the revised labeling recommendations will be incorporated into the 2010 CJD/vCJD guidance, but FDA will otherwise continue with its recommendations in the 2010 CJD/vCJD guidance as currently provided. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 10, 2012. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit 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: Tami Belouin, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Amendment (revisions to labeling recommendations for potential risk of vCJD) to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products’ ’’ dated April 2012. The draft guidance document proposes amendments to labeling recommendations in the 2010 CJD/vCJD guidance for plasma-derived products, including albumin and products containing plasma-derived albumin, to reflect current knowledge of vCJD transmission through blood. When finalized, the revised labeling recommendations will be incorporated into the 2010 CJD/vCJD guidance. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https://www. regulations.gov. Dated: April 17, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–14034 Filed 6–8–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1984. E:\FR\FM\11JNN1.SGM 11JNN1

Agencies

[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34389-34390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14000]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0399]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Progel Pleural Air Leak Sealant

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for Progel Pleural Air Leak Sealant 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 medical device.

ADDRESSES: Submit electronic comments to https://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. 6284, 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 medical devices, the testing 
phase begins with a clinical investigation of the device and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the device and continues until 
permission to market the device is granted. 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 (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 medical device will include 
all of the testing phase and approval phase as specified in 35 U.S.C. 
156(g)(3)(B).
    FDA recently approved for marketing the medical device, Progel 
Pleural Air Leak Sealant. Progel Pleural Air Leak Sealant is indicated 
for application to visceral pleura during an open thoracotomy after 
standard visceral pleural closure with, for example, sutures or 
staples, of visible air leaks (>=2 mm) incurred during open resection 
of lung parenchyma. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
Progel Pleural Air Leak Sealant (U.S. Patent No. RE38158) from Neomend, 
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 June 8, 2011, FDA advised the Patent and Trademark Office 
that this medical device had undergone a regulatory review period and 
that the approval of Progel Pleural Air Leak Sealant represented the 
first permitted commercial marketing or use of the product. Thereafter, 
the Patent and Trademark Office requested that the FDA determine the 
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
Progel Pleural Air Leak Sealant is 3,854 days. Of this time, 787 days 
occurred during the testing phase of the regulatory review period, 
while 3067 days occurred during the approval phase. These periods of 
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving 
this device became effective: June 29, 1999. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) required under section 520(g) of the FD&C Act for human tests to 
begin became effective June 29, 1999.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e): August 23, 2001. FDA has verified the applicant's 
claim that the premarket approval application (PMA) for Progel Pleural 
Air Leak Sealant (PMA P010047) was initially submitted August 23, 2001.
    3. The date the application was approved: January 14, 2010. FDA has 
verified the applicant's claim that PMA P010047 was approved on January 
14, 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 5 years 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 August 10, 2012. 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 10, 2012. 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.

[[Page 34390]]

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is only necessary to send one set of comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document.
    Comments and petitions that have not been made publicly available 
on https://www.regulations.gov may be viewed in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 29, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-14000 Filed 6-8-12; 8:45 am]
BILLING CODE 4160-01-P

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