Pediatric Advisory Committee; Notice of Meeting, 18034-18035 [2014-07112]

Download as PDF 18034 Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices community a high priority to help ensure the quality of FDA-regulated ADFO Member ..................... $475.00 products. The public workshop helps to Non-ADFO Member .............. 575.00 achieve objectives set forth in section 406 of the Food and Drug * A $100 registration fee will be added if Administration Modernization Act of payment is postmarked after June 1, 2014. 1997 (21 U.S.C. 393) which includes If you need special accommodations working closely with stakeholders and due to a disability, please contact Randy maximizing the availability and clarity Young (see AFDO Contact information) of information to stakeholders and the at least 21 days in advance of the public. The workshop also is consistent workshop. with the Small Business Regulatory Registration instructions: To register, Enforcement Fairness Act of 1996 (Pub. please complete and submit an AFDO L. 104–121), as outreach activities by Conference Registration Form, along government agencies to small with a check or money order payable to businesses. ‘‘AFDO.’’ Please mail your completed Dated: March 25, 2014. registration form and payment to: AFDO, 2550 Kingston Rd., Suite 311, Leslie Kux, York, PA 17402. To register online, Assistant Commissioner for Policy. please visit http://www.afdo.org/ [FR Doc. 2014–07059 Filed 3–28–14; 8:45 am] conference. (FDA has verified the Web BILLING CODE 4160–01–P site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal DEPARTMENT OF HEALTH AND Register.) HUMAN SERVICES The registrar will also accept payment through Visa and MasterCard credit Food and Drug Administration cards. For more information on the public workshop, or for questions about [Docket No. FDA–2014–N–0001] registration, please contact AFDO at 1– Pediatric Advisory Committee; Notice 717–757–2888, FAX: 717–650–3650, or of Meeting email: afdo@afdo.org. SUPPLEMENTARY INFORMATION: The AGENCY: Food and Drug Administration, public workshop helps fulfill the HHS. Department of Health and Human ACTION: Notice. Services’ and FDA’s important mission This notice announces a forthcoming to protect the public health. The meeting of a public advisory committee workshop will provide FDA-regulated drug and device entities with of the Food and Drug Administration information on a number of topics (FDA). The meeting will be open to the concerning FDA requirements related to public. the production and marketing of drugs Name of Committee: Pediatric and/or devices. Topics for discussion Advisory Committee. include, but are not limited to the General Function of the Committee: following: To provide advice and • Medical Device Single Audit recommendations to the Agency on Program; FDA’s regulatory issues. • Contract Manufacturing Date and Time: The meeting will be Arrangements for Drugs: Quality held on April 21, 2014, from 8 a.m. to Agreements; 5 p.m. This is a reschedule of a • Compliance Question and Answer postponed meeting announced in the Panel; Federal Register of January 14, 2014 (79 • Draft Guidance: Distinguishing FR 2452), originally scheduled for Medical Device Recalls from Product March 3, 2014. Enhancements and Associated Location: Bethesda Marriott, 5151 Reporting Requirements; Pooks Hill Rd., Bethesda, MD 20814, • Compounding Pharmacies; 301–897–9400 or visit the hotel’s Web • Overview of Global Device/Drug site at http://www.marriott.com/hotels/ Requirements vs. U.S. System; travel/wasbt-bethesda-marriott/. • Case for Quality Initiative Update; Contact Person: Walter Ellenberg, • Unique Device Identifier Office of the Commissioner, Food and Implementation Update; Drug Administration, 10903 New • Metric, Data, and Analysis; Hampshire Ave., Bldg. 32, rm. 5154, Biometrics; Silver Spring, MD 20993, 301–796– • Pharmaceutical Inspection 0885, email: walter.ellenberg@ Cooperation Scheme; and fda.hhs.gov, or FDA Advisory • Biosimilar Regulations. FDA has made education of the food, Committee Information Line, 1–800– feed, drug, and device manufacturing 741–8138 (301–443–0572 in the tkelley on DSK3SPTVN1PROD with NOTICES COST OF REGISTRATION * VerDate Mar<15>2010 18:10 Mar 28, 2014 Jkt 232001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 Washington, DC area). 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 at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On April 21, 2014, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107–109) and the Pediatric Research Equity Act (Pub. L. 108–155). The PAC will meet to discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor (recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA (levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA (estradiol valerate and estradiol valerate/dienogest), PERTZYE (pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE (ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA (pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), and VIREAD (tenofovir disoproxil fumarate). 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 http://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 April 14, 2014. Oral presentations from the public will be scheduled on April 21, 2014, between approximately 11:30 a.m. and 12:30 p.m. 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 E:\FR\FM\31MRN1.SGM 31MRN1 Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices requested to make their presentation on or before April 4, 2014. 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 April 7, 2014. 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 Walter Ellenberg 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 http://www.fda.gov/ AdvisoryCommittees/ 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 26, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–07112 Filed 3–28–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–E–0388] Determination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR–13 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for PREVNAR–13 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 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:10 Mar 28, 2014 Jkt 232001 extension of a patent which claims that human biological product. ADDRESSES: Submit electronic comments to http:// www.regulations.gov. Submit written petitions (two copies are required) and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit petitions electronically to http:// www.regulations.gov at Docket No. FDA 2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, 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 biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological 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 biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human biologic product PREVNAR–13 (Pneumococcal 13-valent conjugate vaccine (diphtheria CRM–197 protein)). PREVNAR–13 is indicated for (1) Active PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 18035 immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, in patients aged 6 weeks through 17 years of age and in adults 50 years of age and older; and (2) active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in patients aged 6 weeks through 5 years. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for PREVNAR–13 (U.S. Patent No. 5,614,382) from Wyeth Holdings Corp., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated July 9, 2012, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of PREVNAR–13 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 PREVNAR–13 is 2,102 days. Of this time, 1,771 days occurred during the testing phase of the regulatory review period, while 331 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 (21 U.S.C. 355(i)) became effective: May 26, 2004. The applicant claims April 23, 2004, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was May 26, 2004, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): March 31, 2009. The applicant claims October 24, 2008, as the date the biologics license application (BLA) for PREVNAR–13 (BLA 125324) was initially submitted. However, FDA records indicate that BLA 125324 was a rolling submission and the final module was received by FDA on March 31, 2009. 3. The date the application was approved: February 24, 2010. FDA has verified the applicant’s claim that BLA 125324 was approved on February 24, 2010. E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18034-18035]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07112]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Pediatric 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: Pediatric 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 April 21, 2014, from 8 
a.m. to 5 p.m. This is a reschedule of a postponed meeting announced in 
the Federal Register of January 14, 2014 (79 FR 2452), originally 
scheduled for March 3, 2014.
    Location: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD 
20814, 301-897-9400 or visit the hotel's Web site at http://www.marriott.com/hotels/travel/wasbt-bethesda-marriott/.
    Contact Person: Walter Ellenberg, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154, 
Silver Spring, MD 20993, 301-796-0885, email: 
walter.ellenberg@fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: On April 21, 2014, the Pediatric Advisory Committee (PAC) 
will meet to discuss pediatric-focused safety reviews, as mandated by 
the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the 
Pediatric Research Equity Act (Pub. L. 108-155). The PAC will meet to 
discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor 
(recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA 
(levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA 
(estradiol valerate and estradiol valerate/dienogest), PERTZYE 
(pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE 
(ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA 
(pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), 
and VIREAD (tenofovir disoproxil fumarate).
    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 http://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 
April 14, 2014. Oral presentations from the public will be scheduled on 
April 21, 2014, between approximately 11:30 a.m. and 12:30 p.m. 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

[[Page 18035]]

requested to make their presentation on or before April 4, 2014. 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 April 7, 2014.
    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 Walter Ellenberg 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 http://www.fda.gov/AdvisoryCommittees/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 26, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-07112 Filed 3-28-14; 8:45 am]
BILLING CODE 4160-01-P