Vaccines and Related Biological Products Advisory Committee; Amendment of Notice, 52668-52669 [2011-21535]

Download as PDF 52668 Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices 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: Regarding the guidance: Ellis F. Unger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4208, Silver Spring, MD 20993–0002, 301–796–2270; or Peter F. Bross, Center for Biologics Evaluation and Research (HFM–755), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–5102. Regarding the ICH: Michelle Limoli, Office of International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 3506, Silver Spring, MD 20993, 301–796– 8377. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International VerDate Mar<15>2010 16:33 Aug 22, 2011 Jkt 223001 Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In the Federal Register of August 5, 2008 (73 FR 45462), FDA published a notice announcing the availability of a draft guidance entitled ‘‘E2F Development Safety Update Report.’’ The notice gave interested persons an opportunity to submit comments by November 3, 2008. After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in August 2010. The guidance describes the format, content, and timing of a DSUR for an investigational drug. The DSUR will serve as a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The DSUR is patterned after the periodic safety update report (used for safety reporting in the postmarketing environment) and can be submitted in the United States in place of an annual report for an IND. The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’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 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. It is no longer necessary to send two copies of mailed 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. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 III. Electronic Access Persons with access to the Internet may obtain the document at https://www. regulations.gov, https://www.fda.gov/ Drugs/GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm. Dated: August 16, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–21447 Filed 8–22–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Vaccines and Related Biological Products Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee. This meeting was announced in the Federal Register of July 22, 2011 (76 FR 44016). The amendment is being made to reflect a change in the Date and Time, Location, Agenda, Procedure, and Closed Committee Deliberations portions of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Donald W. Jehn or Denise Royster, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, 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. SUPPLEMENTARY INFORMATION: In the Federal Register of July 22, 2011, FDA announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held on September 20, 2011. On page 44016, in the 2nd and 3rd column and on page 44017, in the 1st column, the Date and Time, Location, Agenda, Procedure, and Closed Committee Deliberations portions of the document are changed to read as follows: E:\FR\FM\23AUN1.SGM 23AUN1 Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices Date and Time: The meeting will be held on September 20, 2011, from 1 p.m. to approximately 4 p.m. Location: National Institutes of Health (NIH), 9000 Rockville Pike, Building 29B, Conference Room C, Bethesda, MD 20892. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at https://www.nih.gov/ about/visitor/index.htm. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Visitors must show two forms of identification, one of which must be a government-issued photo identification such as a Federal employee badge, driver’s license, passport, green card, etc. Detailed information about security procedures is located at https://www.nih.gov/about/ visitorsecurity.htm. Due to the limited available parking visitors are encouraged to use public transportation. Agenda: On September 20, 2011, the committee will meet in open session to hear updates of the research programs in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. Procedure: On September 20, 2011, from 1 p.m. to approximately 3:30 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be 52669 made to the contact person on or before September 13, 2011. Oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 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 requested to make their presentation on or before September 9, 2011. 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 September 10, 2011. Closed Committee Deliberations: On September 20, 2011, from approximately 3:30 p.m. to approximately 4 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the report of the intramural research programs and make recommendations regarding personnel staffing decisions. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: August 18, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. SUPPLEMENTARY INFORMATION: [FR Doc. 2011–21535 Filed 8–22–11; 8:45 am] BILLING CODE 4160–01–P Food and Drug Administration [Docket No. FDA–2011–N–0332] Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability; Correction AGENCY: Food and Drug Administration, HHS. Notice of availability; correction. ACTION: The Food and Drug Administration (FDA) is correcting a notice of availability that appeared in the Federal Register of August 4, 2011 (76 FR 47211). The Agency is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. The August 4, 2011, notice is the Agency’s report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. The document was published with an error. This document corrects that error. SUMMARY: FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3208, Silver Spring, MD 20993–0002, 301–796–9148. In FR Doc. 2011–19806, appearing on page 47211 in the Federal Register of August 4, 2011, the following correction is made: On page 47214, table 1 is corrected to read as follows: TABLE 1—SUMMARY OF POSTMARKETING REQUIREMENTS AND COMMITMENTS [Numbers as of September 30, 2010] NDA/ANDA (% of Total PMR or % of total PMC) mstockstill on DSK4VPTVN1PROD with NOTICES Number of open PMRs ............................................................................. On-schedule open PMRs (see table 2 of this document) ................. Off-schedule open PMRs (see table 3 of this document) ................. Number of open PMCs 2 ........................................................................... On-schedule open PMCs (see table 4 of this document) ................. Off-schedule open PMCs (see table 5 of this document) ................. 526 477 (91%) 49 (9%) 473 399 (84%) 74 (16%) BLA (% of Total PMR or % of total PMC) 1 149. 131 (88%). 18 (12%). 307. 236 (77%). 71 (23%). 1 On October 1, 2003, FDA completed a consolidation of certain therapeutic products formerly regulated by CBER into CDER. Consequently, CDER now reviews many BLAs. Fiscal year statistics for postmarketing requirements and commitments for BLAs reviewed by CDER are included in BLA totals in this table. 2 The number of PMCs reported as open as of September 30, 2009, in the ‘‘Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments’’ notice published in the Federal Register on November 9, 2010 (75 FR 68802), inadvertently also included open PMRs. That error has been corrected for the current reporting period. VerDate Mar<15>2010 16:33 Aug 22, 2011 Jkt 223001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\23AUN1.SGM 23AUN1

Agencies

[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52668-52669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Vaccines and Related Biological Products Advisory Committee; 
Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the Vaccines and Related Biological 
Products Advisory Committee. This meeting was announced in the Federal 
Register of July 22, 2011 (76 FR 44016). The amendment is being made to 
reflect a change in the Date and Time, Location, Agenda, Procedure, and 
Closed Committee Deliberations portions of the document. There are no 
other changes.

FOR FURTHER INFORMATION CONTACT: Donald W. Jehn or Denise Royster, 
Center for Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, 
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.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 22, 2011, 
FDA announced that a meeting of the Vaccines and Related Biological 
Products Advisory Committee would be held on September 20, 2011. On 
page 44016, in the 2nd and 3rd column and on page 44017, in the 1st 
column, the Date and Time, Location, Agenda, Procedure, and Closed 
Committee Deliberations portions of the document are changed to read as 
follows:

[[Page 52669]]

    Date and Time: The meeting will be held on September 20, 2011, from 
1 p.m. to approximately 4 p.m.
    Location: National Institutes of Health (NIH), 9000 Rockville Pike, 
Building 29B, Conference Room C, Bethesda, MD 20892. The public is 
welcome to attend the meeting at the specified location where a 
speakerphone will be provided. Public participation in the meeting is 
limited to the use of the speakerphone in the conference room. 
Important information about transportation and directions to the NIH 
campus, parking, and security procedures is available on the Internet 
at https://www.nih.gov/about/visitor/index.htm. (FDA has verified the 
Web site address, but FDA is not responsible for any subsequent changes 
to the Web site after this document publishes in the Federal Register.) 
Visitors must show two forms of identification, one of which must be a 
government-issued photo identification such as a Federal employee 
badge, driver's license, passport, green card, etc. Detailed 
information about security procedures is located at https://www.nih.gov/about/visitorsecurity.htm. Due to the limited available parking 
visitors are encouraged to use public transportation.
    Agenda: On September 20, 2011, the committee will meet in open 
session to hear updates of the research programs in the Laboratory of 
Enteric and Sexually Transmitted Diseases, Division of Bacterial, 
Parasitic, and Allergenic Products, Office of Vaccines Research and 
Review, Center for Biologics Evaluation and Research, FDA.
    Procedure: On September 20, 2011, from 1 p.m. to approximately 3:30 
p.m., the meeting is open to the public. 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 September 13, 2011. Oral presentations from the 
public will be scheduled between approximately 2:30 p.m. and 3:30 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 requested to make their presentation on or before 
September 9, 2011. 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 September 10, 
2011.
    Closed Committee Deliberations: On September 20, 2011, from 
approximately 3:30 p.m. to approximately 4 p.m., the meeting will be 
closed to permit discussion where disclosure would constitute a clearly 
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The 
committee will discuss the report of the intramural research programs 
and make recommendations regarding personnel staffing decisions.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: August 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-21535 Filed 8-22-11; 8:45 am]
BILLING CODE 4160-01-P
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