80_FR_50800 80 FR 50639 - Bone, Reproductive, and Urologic Drugs Advisory Committee; Notice of Meeting

80 FR 50639 - Bone, Reproductive, and Urologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 161 (August 20, 2015)

Page Range50639-50640
FR Document2015-20540

Federal Register, Volume 80 Issue 161 (Thursday, August 20, 2015) 
[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50639-50640]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20540]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Bone, Reproductive, and Urologic Drugs Advisory Committee; Notice 
of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Bone, Reproductive, and Urologic Drugs 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 November 3, 2015, from 
8:30 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 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: BRUDAC@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: The committee will discuss new drug application (NDA) 
207959, enclomiphene citrate 12.5 milligram (mg) and 25 mg capsules, 
submitted by Repros Therapeutics, Inc., for the proposed treatment of 
secondary hypogonadism in fertile men (men with more than 15 million 
sperm/milliliter (ml)), younger than 60 years of age with a Body Mass 
Index (BMI) over 25 kilograms (kg)/meters squared (m2).
    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 
October 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 October 9, 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

[[Page 50640]]

hearing session. The contact person will notify interested persons 
regarding their request to speak by October 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: August 14, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-20540 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Notices 50639 proposed in the USDA Action plan, the meeting. A copy of the transcript 741–8138 (301–443–0572 in the including a number of initiatives related will be available for public examination Washington, DC area). A notice in the to collecting on-farm antibiotic use and at the Division of Dockets Management Federal Register about last minute resistance data. (see Comments) between 9 a.m. and 4 modifications that impact a previously Gathering information on the way p.m., Monday through Friday. In announced advisory committee meeting medically important antimicrobials are addition, copies of the transcript will be cannot always be published quickly used in food-producing animals is available in either hardcopy or on CD– enough to provide timely notice. essential to measuring the impact of the ROM after submission of a Freedom of Therefore, you should always check the FDA’s GFI #213. FDA is collaborating Information request. The Freedom of Agency’s Web site at http:// with USDA and CDC to develop a plan Information office address is available www.fda.gov/AdvisoryCommittees/ for collecting additional on-farm data on on the Agency’s Web site at http:// default.htm and scroll down to the antimicrobial use and resistance. Such www.fda.gov. appropriate advisory committee meeting data are intended to supplement link, or call the advisory committee Dated: August 14, 2015. existing information, including data on information line to learn about possible the quantity of antimicrobials sold or Leslie Kux, modifications before coming to the distributed for use in food-producing Associate Commissioner for Policy. meeting. animals (reported under section 105 of [FR Doc. 2015–20557 Filed 8–19–15; 8:45 am] Agenda: The committee will discuss the Animal Drug User Fee Amendments BILLING CODE 4164–01–P new drug application (NDA) 207959, of 2008) and data on antimicrobial enclomiphene citrate 12.5 milligram resistance (e.g., collected under the (mg) and 25 mg capsules, submitted by National Antimicrobial Resistance DEPARTMENT OF HEALTH AND Repros Therapeutics, Inc., for the Monitoring System and the National HUMAN SERVICES proposed treatment of secondary Animal Health Monitoring System). hypogonadism in fertile men (men with Data from multiple sources are needed Food and Drug Administration more than 15 million sperm/milliliter to provide a comprehensive and [Docket No. FDA–2015–N–0001] (ml)), younger than 60 years of age with science-based picture of antimicrobial a Body Mass Index (BMI) over 25 drug use and resistance in animal Bone, Reproductive, and Urologic kilograms (kg)/meters squared (m2). agriculture. Drugs Advisory Committee; Notice of FDA intends to make background A data collection plan is needed to Meeting material available to the public no later obtain additional information necessary than 2 business days before the meeting. to: (1) Assess the rate of adoption of AGENCY: Food and Drug Administration, If FDA is unable to post the background changes outlined in the FDA’s GFI #213; HHS. material on its Web site prior to the (2) help gauge the success of antibiotic ACTION: Notice. meeting, the background material will stewardship efforts and guide their be made publicly available at the This notice announces a forthcoming location of the advisory committee continued evolution and optimization; meeting of a public advisory committee meeting and the background material and (3) assess associations between of the Food and Drug Administration will be posted on FDA’s Web site after antibiotic use practices and resistance. (FDA). The meeting will be open to the the meeting. Background material is FDA is continuing to work with the public. available at http://www.fda.gov/ USDA and CDC in developing this plan, Name of Committee: Bone, AdvisoryCommittees/Calendar/ and is holding this public meeting in Reproductive, and Urologic Drugs default.htm. Scroll down to the order to obtain input from the public. Advisory Committee. appropriate advisory committee meeting This meeting is the first opportunity for General Function of the Committee: link. public input as part of our ongoing To provide advice and Procedure: Interested persons may effort to develop and implement plans recommendations to the Agency on present data, information, or views, for collecting additional on-farm FDA’s regulatory issues. orally or in writing, on issues pending antimicrobial drug use and resistance Date and Time: The meeting will be before the committee. Written data. held on November 3, 2015, from 8:30 submissions may be made to the contact II. Agenda a.m. to 5 p.m. person on or before October 20, 2015. The public meeting will provide an Location: FDA White Oak Campus, Oral presentations from the public will opportunity for public comment on 10903 New Hampshire Ave., Bldg. 31 be scheduled between approximately 1 possible approaches for collecting Conference Center, the Great Room (rm. p.m. and 2 p.m. Those individuals additional antimicrobial drug use data. 1503), Silver Spring, MD 20993–0002. interested in making formal oral The final agenda for the public meeting Answers to commonly asked questions presentations should notify the contact will be made available on the Agency’s including information regarding special person and submit a brief statement of Web site at accommodations due to a disability, the general nature of the evidence or http://www.fda.gov/ visitor parking, and transportation may arguments they wish to present, the AnimalVeterinary/NewsEvents/ be accessed at: http://www.fda.gov/ names and addresses of proposed WorkshopsConferencesMeetings/ AdvisoryCommittees/ participants, and an indication of the ucm456380.htm no later than 2 weeks AboutAdvisoryCommittees/ approximate time requested to make prior to the meeting. ucm408555.htm. their presentation on or before October Contact Person: Kalyani Bhatt, Center 9, 2015. Time allotted for each III. Transcript tkelley on DSK3SPTVN1PROD with NOTICES for Drug Evaluation and Research, Food presentation may be limited. If the FDA will prepare a meeting transcript and Drug Administration, 10903 New number of registrants requesting to and make it available on the Agency’s Hampshire Ave., Bldg. 31, Rm. 2417, speak is greater than can be reasonably Web site (see section II) after the Silver Spring, MD 20993–0002, 301– accommodated during the scheduled meeting. FDA anticipates that the 796–9001, FAX: 301–847–8533, email: open public hearing session, FDA may transcript will be available BRUDAC@fda.hhs.gov, or FDA Advisory conduct a lottery to determine the approximately 60 business days after Committee Information Line, 1–800– speakers for the scheduled open public VerDate Sep<11>2014 17:31 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1

50640 Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Notices hearing session. The contact person will including each proposed extension of an collection of information, including the notify interested persons regarding their existing collection of information, and validity of the methodology and request to speak by October 13, 2015. to allow 60 days for public comment in assumptions used; (3) ways to enhance Persons attending FDA’s advisory response to the notice. This notice the quality, utility, and clarity of the committee meetings are advised that the solicits comments on the information information to be collected; and (4) Agency is not responsible for providing collection provisions of the Interstate ways to minimize the burden of the access to electrical outlets. Shellfish Dealers Certificate. collection of information on FDA welcomes the attendance of the DATES: Submit either electronic or respondents, including through the use public at its advisory committee written comments on the collection of of automated collection techniques, meetings and will make every effort to information by October 19, 2015. when appropriate, and other forms of accommodate persons with physical ADDRESSES: Submit electronic information technology. disabilities or special needs. If you comments on the collection of Interstate Shellfish Dealer’s Certificate require special accommodations due to information to http:// a disability, please contact Kalyani www.regulations.gov. Submit written OMB Control Number 0910–0021— Bhatt at least 7 days in advance of the comments on the collection of Extension meeting. information to the Division of Dockets FDA is committed to the orderly Under 42 U.S.C. 243, we are required Management (HFA–305), Food and Drug conduct of its advisory committee to cooperate with and aid State and Administration, 5630 Fishers Lane, Rm. meetings. Please visit our Web site at local authorities in the enforcement of 1061, Rockville, MD 20852. All http://www.fda.gov/ their health regulations and are comments should be identified with the AdvisoryCommittees/ docket number found in brackets in the authorized to assist States in the AboutAdvisoryCommittees/ heading of this document. prevention and suppression of ucm111462.htm for procedures on communicable diseases. Under this FOR FURTHER INFORMATION CONTACT: FDA public conduct during advisory authority, we participate with State PRA Staff, Office of Operations, Food committee meetings. regulatory agencies, some foreign and Drug Administration, 8455 Notice of this meeting is given under nations, and the molluscan shellfish Colesville Rd., COLE–14526, Silver the Federal Advisory Committee Act (5 industry in the National Shellfish Spring, MD 20993–0002, PRAStaff@ U.S.C. app. 2). Sanitation Program (NSSP). fda.hhs.gov. NSSP is a voluntary, cooperative Dated: August 14, 2015. SUPPLEMENTARY INFORMATION: Under the program to promote the safety of Jill Hartzler Warner, PRA (44 U.S.C. 3501–3520), Federal molluscan shellfish by providing for the Associate Commissioner for Special Medical Agencies must obtain approval from the classification and patrol of shellfish Programs. Office of Management and Budget growing waters and for the inspection [FR Doc. 2015–20540 Filed 8–19–15; 8:45 am] (OMB) for each collection of and certification of shellfish processors. BILLING CODE 4164–01–P information they conduct or sponsor. Each participating State and foreign ‘‘Collection of information’’ is defined nation monitors its molluscan shellfish in 44 U.S.C. 3502(3) and 5 CFR processors and issues certificates for DEPARTMENT OF HEALTH AND 1320.3(c) and includes Agency requests those that meet the State or foreign HUMAN SERVICES or requirements that members of the shellfish control authority’s criteria. public submit reports, keep records, or Food and Drug Administration Each participating State and nation provide information to a third party. provides a certificate of its certified [Docket No. FDA–2009–N–0232] Section 3506(c)(2)(A) of the PRA (44 shellfish processors to FDA on Form U.S.C. 3506(c)(2)(A)) requires Federal FDA 3038, ‘‘Interstate Shellfish Dealer’s Agency Information Collection Agencies to provide a 60-day notice in Certificate.’’ We use this information to Activities; Proposed Collection; the Federal Register concerning each proposed collection of information, publish the ‘‘Interstate Certified Comment Request; Comment Request; Shellfish Shippers List,’’ a monthly Interstate Shellfish Dealers Certificate including each proposed extension of an existing collection of information, comprehensive listing of all molluscan AGENCY: Food and Drug Administration, before submitting the collection to OMB shellfish processors certified under the HHS. for approval. To comply with this cooperative program. If we did not requirement, we are publishing notice of collect the information necessary to ACTION: Notice. the proposed collection of information compile this list, participating States SUMMARY: The Food and Drug set forth in this document. would not be able to identify and keep Administration (FDA or we) is With respect to the following out shellfish processed by uncertified announcing an opportunity for public collection of information, we invite processors in other States and foreign comment on our proposed collection of comments on these topics: (1) Whether nations. Consequently, NSSP would not certain information by the Agency. the proposed collection of information be able to control the distribution of Under the Paperwork Reduction Act of is necessary for the proper performance uncertified and possibly unsafe shellfish 1995 (the PRA), Federal Agencies are of FDA’s functions, including whether in interstate commerce, and its required to publish notice in the the information will have practical effectiveness would be nullified. Federal Register concerning each utility; (2) the accuracy of FDA’s We estimate the burden of this proposed collection of information, estimate of the burden of the proposed collection of information as follows: tkelley on DSK3SPTVN1PROD with NOTICES VerDate Sep<11>2014 17:31 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1


Document Created: 2015-12-15 11:08:40
Document Modified: 2015-12-15 11:08:40
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 50639 
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