80_FR_26368 80 FR 26280 - Joint Meeting of the Bone, Reproductive, and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

80 FR 26280 - Joint Meeting of the Bone, Reproductive, and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

Page Range26280-26281
FR Document2015-11013

Federal Register, Volume 80 Issue 88 (Thursday, May 7, 2015) 
[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26280-26281]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11013]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Joint Meeting of the Bone, Reproductive, and Urologic Drugs 
Advisory Committee, and the Drug Safety and Risk Management Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of two public advisory 
committees of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committees: Bone, Reproductive, and Urologic Drugs Advisory 
Committee, and the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 4, 2015, from 8 
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions

[[Page 26281]]

including information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Kalyani Bhatt, 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: [email protected], 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: The committees will discuss new drug application (NDA) 
022526, flibanserin 100 milligram (mg) tablets, submitted by Sprout 
Pharmaceuticals Inc., proposed for the treatment of hypoactive sexual 
desire disorder (HSDD) in premenopausal women.
    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 meeting 
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 
20, 2015. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 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 May 12, 2015. 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 13, 2015.
    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 Kalyani Bhatt 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: May 4, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-11013 Filed 5-6-15; 8:45 am]
 BILLING CODE 4164-01-P

26280 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices each respondent 1.5 hours annually to provision. We estimate that it will take Importers report malfunctions only to maintain the records. each respondent 10 hours annually to the manufacturers, unless they are The Agency has estimated that on establish new procedures, or revise unknown, then the reports are sent to average, 220 user facilities, importers, existing procedures. FDA. We estimate that it will take and manufacturers would annually be Third-Party Disclosure Burden respondents 1 hour annually to report required, under § 803.17, to establish the information. Under §§ 803.40 and 803.42, device new procedures, or revise existing importers report deaths and serious FDA estimates the burden of this procedures, in order to comply with this injuries to the manufacturers and FDA. collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual CFR section FDA form No. responses per burden per Total hours respondents responses respondent response Exemptions—803.19 ................................ ........................ 57 4 228 3 684 User Facility Reporting—803.30 and 803.32 ................................................... ........................ 544 9 4,896 1 4,896 User Facility Annual Reporting—803.33 3419 195 1 195 1 195 Importer Reporting, Death and Serious Injury—803.40 and 803.42 ................... ........................ 1 1 1 1 1 Manufacturer Reporting—803.50, through 803.53 ..................................... ........................ 1,239 243 301,077 1 301,077 Supplemental Reports—803.56 ............... ........................ 124 302 37,448 1 37,448 Total .................................................. ........................ ........................ ........................ ........................ ........................ 344,301 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Average Number of Total annual 21 CFR section records per burden per Total hours recordkeepers records recordkeeper record MDR Procedures—803.17 ................................................. 220 1 220 10 2,200 MDR Files—803.18 ............................................................ 30,000 1 30,000 1.5 45,000 Total ............................................................................ ........................ ........................ ........................ .......................... 47,200 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual 21 CFR section burden per Total hours respondents per disclosures disclosure respondent Importer Reporting, Malfunctions—803.40 and 803.42 ....... 1 25 25 1 25 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 4, 2015. DEPARTMENT OF HEALTH AND Administration (FDA). The meeting will Leslie Kux, HUMAN SERVICES be open to the public. Associate Commissioner for Policy. Name of Committees: Bone, Food and Drug Administration Reproductive, and Urologic Drugs [FR Doc. 2015–10995 Filed 5–6–15; 8:45 am] Advisory Committee, and the Drug BILLING CODE 4164–01–P [Docket No. FDA–2015–N–0001] Safety and Risk Management Advisory Committee. Joint Meeting of the Bone, General Function of the Committees: Reproductive, and Urologic Drugs To provide advice and Advisory Committee, and the Drug recommendations to the Agency on Safety and Risk Management Advisory FDA’s regulatory issues. Committee; Notice of Meeting Date and Time: The meeting will be mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, held on June 4, 2015, from 8 a.m. to 5 HHS. p.m. ACTION: Notice. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 This notice announces a forthcoming Conference Center, the Great Room (Rm. meeting of two public advisory 1503), Silver Spring, MD 20993–0002. committees of the Food and Drug Answers to commonly asked questions VerDate Sep<11>2014 18:57 May 06, 2015 Jkt 235001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1

Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 26281 including information regarding special approximate time requested to make Office of Management and Budget accommodations due to a disability, their presentation on or before May 12, (OMB). Prior to submitting that ICR to visitor parking, and transportation may 2015. Time allotted for each OMB, OS seeks comments from the be accessed at: http://www.fda.gov/ presentation may be limited. If the public regarding the burden estimate, AdvisoryCommittees/AboutAdvisory number of registrants requesting to below, or any other aspect of the ICR. Committees/ucm408555.htm. speak is greater than can be reasonably DATES: Comments on the ICR must be Contact Person: Kalyani Bhatt, Center accommodated during the scheduled received on or before July 6, 2015. for Drug Evaluation and Research, Food open public hearing session, FDA may and Drug Administration, 10903 New ADDRESSES: Submit your comments to conduct a lottery to determine the Hampshire Ave., Bldg. 31, Rm. 2417, speakers for the scheduled open public Information.CollectionClearance@ Silver Spring, MD 20993–0002, 301– hearing session. The contact person will hhs.gov or by calling (202) 690–6162. 796–9001, FAX: 301–847–8533, email: notify interested persons regarding their FOR FURTHER INFORMATION CONTACT: BRUDAC@fda.hhs.gov, or FDA Advisory request to speak by May 13, 2015. Information Collection Clearance staff, Committee Information Line, 1–800– Persons attending FDA’s advisory Information.CollectionClearance@ 741–8138 (301–443–0572 in the committee meetings are advised that the hhs.gov or (202) 690–6162. Washington, DC area). A notice in the Agency is not responsible for providing SUPPLEMENTARY INFORMATION: When Federal Register about last minute access to electrical outlets. submitting comments or requesting modifications that impact a previously FDA welcomes the attendance of the information, please include the announced advisory committee meeting public at its advisory committee document identifier HHS–OS–0990– cannot always be published quickly meetings and will make every effort to 0424–60D for reference. enough to provide timely notice. accommodate persons with physical Information Collection Request Title: Therefore, you should always check the disabilities or special needs. If you Positive Adolescent Futures (PAF) Agency’s Web site at http:// require special accommodations due to Study. www.fda.gov/AdvisoryCommittees/ a disability, please contact Kalyani default.htm and scroll down to the Abstract: The Office of Adolescent Bhatt at least 7 days in advance of the appropriate advisory committee meeting Health (OAH), U.S. Department of meeting. link, or call the advisory committee Health and Human Services (HHS) is FDA is committed to the orderly information line to learn about possible requesting approval by OMB on a conduct of its advisory committee modifications before coming to the revised data collection. The Positive meetings. Please visit our Web site at meeting. Adolescent Futures (PAF) Study will http://www.fda.gov/ Agenda: The committees will discuss provide information about program AdvisoryCommittees/ new drug application (NDA) 022526, design, implementation, and impacts AboutAdvisoryCommittees/ flibanserin 100 milligram (mg) tablets, through a rigorous assessment of ucm111462.htm for procedures on submitted by Sprout Pharmaceuticals program impacts and implementation of public conduct during advisory Inc., proposed for the treatment of two programs designed to support committee meetings. hypoactive sexual desire disorder Notice of this meeting is given under expectant and parenting teens. These (HSDD) in premenopausal women. the Federal Advisory Committee Act (5 programs are located in Houston, Texas FDA intends to make background U.S.C. app. 2). and throughout the state of California. material available to the public no later The revision to this information Dated: May 4, 2015. collection request includes the 12- than 2 business days before the meeting. Jill Hartzler Warner, month follow-up survey instrument If FDA is unable to post the background material on its Web site prior to the Associate Commissioner for Special Medical related to the impact study. The Programs. collected data from this instrument will meeting, the background material will be made publicly available at the [FR Doc. 2015–11013 Filed 5–6–15; 8:45 am] provide a detailed understanding of the location of the advisory committee BILLING CODE 4164–01–P program impacts within the two study meeting and the background material sites about one year after youth are will be posted on FDA’s Web site after enrolled in the study. Plus, have first the meeting. Background material is DEPARTMENT OF HEALTH AND access to the programming offered by available at http://www.fda.gov/ HUMAN SERVICES each site. Clearance is requested for AdvisoryCommittees/Calendar/ three years. Office of the Secretary Need and Proposed Use of the default.htm. Scroll down to the appropriate advisory committee meeting [Document Identifier: HHS–OS–0990–0424– Information: The data will serve two link. 60D] main purposes. First, the data will be Procedure: Interested persons may used to determine program effectiveness present data, information, or views, Agency Information Collection by comparing outcomes on repeat orally or in writing, on issues pending Activities; Proposed Collection; Public pregnancies, sexual risk behaviors, before the committee. Written Comment Request health and well-being, and parenting submissions may be made to the contact AGENCY: Office of the Assistant behaviors between treatment (program) person on or before May 20, 2015. Oral Secretary for Health, Office of and control youth. Second, the data will presentations from the public will be Adolescent Health, HHS. be used to understand whether the scheduled between approximately 1 ACTION: Notice. programs are more effective for some mstockstill on DSK4VPTVN1PROD with NOTICES p.m. and 2 p.m. Those individuals youth than others. The findings from interested in making formal oral SUMMARY: In compliance with section these analyses of program impacts will presentations should notify the contact 3506(c)(2)(A) of the Paperwork be of interest to the general public, to person and submit a brief statement of Reduction Act of 1995, the Office of the policymakers, and to organizations the general nature of the evidence or Secretary (OS), Department of Health interested in supporting expectant and arguments they wish to present, the and Human Services, announces plans parenting teens. names and addresses of proposed to submit an Information Collection Likely Respondents: 1,913 study participants, and an indication of the Request (ICR), described below, to the participants. VerDate Sep<11>2014 18:07 May 06, 2015 Jkt 235001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1


Document Created: 2015-12-16 07:50:49
Document Modified: 2015-12-16 07:50:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation80 FR 26280 
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