Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 75176-75177 [2012-30517]

Download as PDF 75176 Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices the draft guidance. We estimate that the submission of each summary level clinical site dataset will take approximately 26 hours to prepare. Initial preparation of the summary level clinical site dataset would involve the development of new SOPs for the preparation of the summary level clinical site dataset. We estimate that 75 applicants would take approximately 12 hours to develop and subsequently 1 hour annually to maintain and update the SOP(s). The summary level clinical site dataset submitted with each application would likely involve additional quality assurance procedures, which would add approximately 1 hour for each submission. This draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in part 312 have been approved under OMB control number 0910–0014; the collections of information in part 314 have been approved under OMB control number 0910–0001. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED REPORTING BURDEN 1 Number of respondents (i.e. applicants) Activity Number of responses per respondent (i.e., applications) Total responses Hours per response Total hours Summary Level Clinical Site Dataset Submissions ............. Dataset Quality Assurance .................................................. 75 75 1.3 1.3 96 96 26 1 2,496 96 Total .............................................................................. ........................ ........................ ........................ ........................ 2,592 1 There are no capital costs or operating and maintenance costs associated with this information collection. TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1 Number of recordkeepers Activity Number of records per recordkeeper Total records Hours per recordkeeper Total hours Develop Initial SOP(s) ......................................................... Maintain and Update SOP(s) ............................................... 75 75 1 1 75 75 12 1 900 75 Total .............................................................................. ........................ ........................ ........................ ........................ 975 1 There are no capital costs or operating and maintenance costs associated with this information collection. IV. Electronic Access Persons with access to the Internet may obtain the document at either http: //www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https://www. regulations.gov. Dated: December 13, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–30510 Filed 12–18–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0548] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. sroberts on DSK5SPTVN1PROD with 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. This meeting is being VerDate Mar<15>2010 18:26 Dec 18, 2012 Jkt 229001 rescheduled due to the postponement of the October 29–30, 2012, Drug Safety and Risk Management Advisory Committee meeting due to unanticipated weather conditions caused by Hurricane Sandy. Name of Committee: Drug Safety and Risk Management 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 January 24, 2013, from 8 a.m. to 6 p.m., and January 25, 2013, from 8 a.m. to 5 p.m. This meeting is a reschedule of a postponed meeting announced in the Federal Register of June 8, 2012 (77 FR 34051–34052), originally scheduled for October 29–30, 2012. ADDRESSES: FDA has opened a docket for public comment on this meeting. The docket number is FDA–2012–N– 0548. The docket opened for public comment on June 8, 2012. The docket will close on February 1, 2013. Interested persons may submit either electronic or written comments regarding this meeting. Submit electronic comments to https:// www.regulations.gov. Submit written PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments received will be posted without change, including any personal information provided. 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. Comments received on or before January 9, 2013, will be provided to the committee before the meeting. Any comments received for the originally scheduled October 29 and 30, 2012, Drug Safety and Risk Management Advisory Committee meeting will be provided to the committee. It is not necessary to resubmit any comments previously submitted to the docket. If a comment originally submitted to the docket is resubmitted prior to January 9, 2013, both comments will be provided to the committee. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD, 20993– E:\FR\FM\19DEN1.SGM 19DEN1 sroberts on DSK5SPTVN1PROD with Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Kristina Toliver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, Fax: 301–847–8533, email: DSaRM@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 https:// 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 January 24 and 25, 2013, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products. The committee will also discuss the impact of rescheduling these hydrocodone products from Schedule III to Schedule II. Background materials for the originally scheduled October 29–30, 2012, Drug Safety and Risk Management Advisory Committee meeting are currently available at https:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ DrugSafety andRiskManagementAdvisory Committee/ucm307385.htm. FDA intends to make background material available to the public no later than 2 business days before the January 24 and 25, 2013, Drug Safety and Risk Management Advisory Committee meeting at: https://www.fda.gov/ VerDate Mar<15>2010 16:35 Dec 18, 2012 Jkt 229001 AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. If FDA is unable to post 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 background material will be posted on FDA’s Web site after the meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the docket (see the ADDRESSES section of this document) on or before January 9, 2013, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 10:15 a.m. on January 25, 2013. Those individuals interested in making formal oral presentations, including those who have previously requested time to speak at the originally scheduled October 29–30, 2012, Drug Safety and Risk Management Advisory Committee meeting, 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 January 3, 2013. Any individuals who requested time to speak at the originally scheduled October 29– 30, 2012, Drug Safety and Risk Management Advisory Committee meeting, will need to follow the above instructions to request time to speak at the January 24–25, 2013, Drug Safety and Risk Management Advisory Committee meeting, as any previous requests to speak at the originally scheduled meeting do not convey to this new January 24–25, 2013, Drug Safety and Risk Management Advisory Committee meeting. 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 January 4, 2013. 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 75177 disabilities or special needs. If you require special accommodations due to a disability, please contact Kristina Toliver 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/ AdvisoryCommittees/About AdvisoryCommittees/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: December 10, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–30517 Filed 12–18–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1172] Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public hearing; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public hearing to obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain. DATES: The public hearing will be held on February 7 and 8, 2013, from 9 a.m. to 4 p.m. Submit electronic or written requests to make oral presentations and comments by January 18, 2013. Electronic or written comments will be accepted after the hearing until April 8, 2013. ADDRESSES: The public hearing will be held at the Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814, 301–897–9400, Fax 1–301–897–0192. Submit electronic comments 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. All comments should be identified with the docket number found in brackets in the heading of this document. Transcripts of the hearing will be available for review at the Division of SUMMARY: E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75176-75177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30517]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0548]


Drug Safety and Risk Management 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. This meeting is being rescheduled due to the 
postponement of the October 29-30, 2012, Drug Safety and Risk 
Management Advisory Committee meeting due to unanticipated weather 
conditions caused by Hurricane Sandy.
    Name of Committee: Drug Safety and Risk Management 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 January 24, 2013, from 8 
a.m. to 6 p.m., and January 25, 2013, from 8 a.m. to 5 p.m. This 
meeting is a reschedule of a postponed meeting announced in the Federal 
Register of June 8, 2012 (77 FR 34051-34052), originally scheduled for 
October 29-30, 2012.

ADDRESSES: FDA has opened a docket for public comment on this meeting. 
The docket number is FDA-2012-N-0548. The docket opened for public 
comment on June 8, 2012. The docket will close on February 1, 2013. 
Interested persons may submit either electronic or written comments 
regarding this meeting. Submit electronic comments 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. All comments received will be posted 
without change, including any personal information provided. 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. Comments received on 
or before January 9, 2013, will be provided to the committee before the 
meeting. Any comments received for the originally scheduled October 29 
and 30, 2012, Drug Safety and Risk Management Advisory Committee 
meeting will be provided to the committee. It is not necessary to 
resubmit any comments previously submitted to the docket. If a comment 
originally submitted to the docket is resubmitted prior to January 9, 
2013, both comments will be provided to the committee.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD, 
20993-

[[Page 75177]]

0002. Information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Contact Person: Kristina Toliver, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-
8533, email: DSaRM@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 https://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 January 24 and 25, 2013, the committee will discuss the 
public health benefits and risks, including the potential for abuse, of 
drugs containing hydrocodone either combined with other analgesics or 
as an antitussive. The Department of Health and Human Services received 
a request from the Drug Enforcement Administration for a scientific and 
medical evaluation and scheduling recommendation for these products in 
response to continued reports of misuse, abuse, and addiction related 
to these products. The committee will also discuss the impact of 
rescheduling these hydrocodone products from Schedule III to Schedule 
II.
    Background materials for the originally scheduled October 29-30, 
2012, Drug Safety and Risk Management Advisory Committee meeting are 
currently available at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm307385.htm. FDA intends 
to make background material available to the public no later than 2 
business days before the January 24 and 25, 2013, Drug Safety and Risk 
Management Advisory Committee meeting at: https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate 
advisory committee meeting link. If FDA is unable to post 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 background material will be posted on FDA's Web 
site after the meeting.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
All electronic and written submissions submitted to the docket (see the 
ADDRESSES section of this document) on or before January 9, 2013, will 
be provided to the committee. Oral presentations from the public will 
be scheduled between approximately 8:15 a.m. and 10:15 a.m. on January 
25, 2013. Those individuals interested in making formal oral 
presentations, including those who have previously requested time to 
speak at the originally scheduled October 29-30, 2012, Drug Safety and 
Risk Management Advisory Committee meeting, 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 January 3, 2013. Any 
individuals who requested time to speak at the originally scheduled 
October 29-30, 2012, Drug Safety and Risk Management Advisory Committee 
meeting, will need to follow the above instructions to request time to 
speak at the January 24-25, 2013, Drug Safety and Risk Management 
Advisory Committee meeting, as any previous requests to speak at the 
originally scheduled meeting do not convey to this new January 24-25, 
2013, Drug Safety and Risk Management Advisory Committee meeting. 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 January 4, 2013.
    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 Kristina Toliver 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/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: December 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30517 Filed 12-18-12; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.