Blood Products Advisory Committee; Notice of Meeting, 20643-20644 [2012-8167]

Download as PDF Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices June 1, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 4, 2012. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Ann Marie Williams, at AnnMarie.Williams@fda.hhs.gov or 301–796–5966, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 30, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–8166 Filed 4–4–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. Tkelley on DSK3SPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. VerDate Mar<15>2010 16:20 Apr 04, 2012 Jkt 226001 Date and Time: The meeting will be held on May 15, 2012, from 8:30 a.m. to 5 p.m. and May 16, 2012 from 8 a.m. to 4 p.m. Location: Hilton Washington DC/ North Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877, 301–977–8900. For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following links. Blood Products Advisory Committee Web Cast Link May 15 https://fda.yorkcast.com/webcast/ Viewer/?peid=ba104b31fe4c4c0995 68bacda9a4e5401d. May 16 https://fda.yorkcast.com/webcast/ Viewer/?peid=19caf3c8c1624acdaab 205ddde9c48581d. Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–1297, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On May 15, 2012, the committee will discuss as a device panel the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test. On May 16, 2012, the committee will discuss the evaluation of possible new plasma products frozen following in-process storage at room temperature for up to 24 hours, namely plasma for transfusion prepared from Whole Blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing. In the afternoon, the committee will hear update presentations on the following topics: HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men; a summary of the November 8–9, 2011, public workshop on hemoglobin standards and maintaining an adequate PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 20643 blood supply; and a summary of the November 29, 2011, public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/default .htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 8, 2012. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 3:15 p.m. on May 15, 2012, and between approximately 11:30 a.m. and 12:45 p.m. on May 16, 2012. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 30, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 1, 2012. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Bryan Emery, 301–827–1277, or Rosanna Harvey, 301– 827–1297, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory E:\FR\FM\05APN1.SGM 05APN1 20644 Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 30, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–8167 Filed 4–4–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–E–0482] Determination of Regulatory Review Period for Purposes of Patent Extension; FLECTOR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for FLECTOR 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:// 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 Tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:20 Apr 04, 2012 Jkt 226001 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 approved for marketing the human drug product FLECTOR (diclofenac epolamine). FLECTOR is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for FLECTOR (U.S. Patent No. 5,607,690) from Altergon S.A., and Teikoku Seiyaku Co., Ltd., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration and that FDA determine the product’s regulatory review period. In a letter dated March 20, 2012, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of FLECTOR represented the first permitted commercial marketing or use of the product. FDA has determined that the applicable regulatory review period for FLECTOR is 4,031 days. Of this time, 1,796 days occurred during the testing phase of the regulatory review period, while 2,235 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 20, 1996. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on January 20, 1996. PO 00000 Frm 00035 Fmt 4703 Sfmt 9990 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 19, 2000. The applicant claims December 18, 2000, as the date the new drug application (NDA) for FLECTOR (NDA 21–344) was initially submitted. However, FDA records indicate that NDA 21–234 is the correct application number for FLECTOR, rather than NDA 21–344. NDA 21–234 for FLECTOR was submitted on December 19, 2000. 3. The date the application was approved: January 31, 2007. FDA has verified the applicant’s claim that FLECTOR (NDA 21–234) was approved on January 31, 2007. 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 1,825 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 June 4, 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 October 2, 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 regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 16, 2012. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2012–8235 Filed 4–4–12; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\05APN1.SGM 05APN1

Agencies

[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20643-20644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8167]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Blood Products Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 15, 2012, from 8:30 
a.m. to 5 p.m. and May 16, 2012 from 8 a.m. to 4 p.m.
    Location: Hilton Washington DC/North Gaithersburg, 620 Perry Pkwy., 
Gaithersburg, MD 20877, 301-977-8900. For those unable to attend in 
person, the meeting will also be Web cast. The Web cast will be 
available at the following links.

Blood Products Advisory Committee Web Cast Link

    May 15
    https://fda.yorkcast.com/webcast/Viewer/?peid=ba104b31fe4c4c099568bacda9a4e5401d.

May 16

    https://fda.yorkcast.com/webcast/Viewer/?peid=19caf3c8c1624acdaab205ddde9c48581d.
    Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics 
Evaluation and Research (HFM-71), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-1297, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), and follow the prompts to the desired center or 
product area. Please call the Information Line for up-to-date 
information on this meeting. A notice in the Federal Register about 
last minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check the Agency's Web site 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On May 15, 2012, the committee will discuss as a device 
panel the evaluation of the safety and effectiveness of the OraQuick 
In-Home HIV Test. On May 16, 2012, the committee will discuss the 
evaluation of possible new plasma products frozen following in-process 
storage at room temperature for up to 24 hours, namely plasma for 
transfusion prepared from Whole Blood held at room temperature for up 
to 24 hours prior to separation and freezing, or from apheresis plasma 
held at room temperature for up to 24 hours before freezing. In the 
afternoon, the committee will hear update presentations on the 
following topics: HHS activities related to the evaluation of the donor 
deferral policy for men who have had sex with other men; a summary of 
the November 8-9, 2011, public workshop on hemoglobin standards and 
maintaining an adequate blood supply; and a summary of the November 29, 
2011, public workshop on data and data needs to advance risk assessment 
for emerging infectious diseases for blood and blood products.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before May 
8, 2012. Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 3:15 p.m. on May 15, 2012, and between 
approximately 11:30 a.m. and 12:45 p.m. on May 16, 2012. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
April 30, 2012. Time allotted for each presentation may be limited. If 
the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by May 1, 2012.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Bryan Emery, 301-
827-1277, or Rosanna Harvey, 301-827-1297, at least 7 days in advance 
of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/Advisory

[[Page 20644]]

Committees/AboutAdvisoryCommittees/ucm111462.htm for procedures on 
public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 30, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-8167 Filed 4-4-12; 8:45 am]
BILLING CODE 4160-01-P

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