81_FR_20044 81 FR 19978 - Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal

81 FR 19978 - Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 66 (April 6, 2016)

Page Range19978-19979
FR Document2016-07908

The Food and Drug Administration (FDA) is announcing the renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Bone, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 23, 2018.

Federal Register, Volume 81 Issue 66 (Wednesday, April 6, 2016) 
[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19978-19979]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Advisory Committee; Bone, Reproductive and Urologic Drugs 
Advisory Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee 
by the Commissioner of Food and Drugs (the Commissioner). The 
Commissioner has determined that it is in the public interest to renew 
the Bone, Reproductive and Urologic Drugs Advisory Committee for an 
additional 2 years beyond the charter expiration date. The new charter 
will be in effect until March 23, 2018.

DATES: Authority for the Bone, Reproductive and Urologic Drugs Advisory 
Committee will expire on March 23, 2018, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Division of Advisory 
Committee and Consultant Management, 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, email: 
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Bone, Reproductive and Urologic Drugs Advisory 
Committee. The committee is a discretionary Federal advisory committee 
established to provide advice to the Commissioner. The Bone, 
Reproductive and Urologic Drugs Advisory Committee advises the 
Commissioner or designee in discharging responsibilities as they relate 
to helping to ensure safe and effective drugs for human use and, as 
required, any other product for which the Food and Drug Administration 
has regulatory responsibility. The Committee reviews and evaluates data 
on the safety and effectiveness of marketed and investigational human 
drug products for use in the practice of osteoporosis and metabolic 
bone disease, obstetrics, gynecology, urology and related specialties, 
and makes appropriate recommendations to the Commissioner of Food and 
Drugs.
    The Committee shall consist of a core of 11 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of osteoporosis and metabolic bone disease, obstetrics, 
gynecology, urology, pediatrics, epidemiology, or statistics and 
related specialties. Members will be invited to serve for overlapping 
terms of up to 4 years. Almost all non-Federal members of this 
committee serve as Special Government Employees. The core of voting 
members may include one technically qualified member, selected by the 
Commissioner or designee, who is identified with consumer interests and 
is recommended by either a consortium of consumer-oriented 
organizations or other interested persons. In addition to the voting 
members, the Committee may include one non-voting member who is 
identified with industry interests.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/ucm107572.htm or by contacting 
the Designated Federal Officer (see FOR FURTHER INFORMATION

[[Page 19979]]

CONTACT). In light of the fact that no change has been made to the 
committee name or description of duties, no amendment will be made to 
21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: April 1, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-07908 Filed 4-5-16; 8:45 am]
 BILLING CODE 4164-01-P

19978 Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices FoodborneIllnessContaminants/Metals/ EMDAC@fda.hhs.gov, or FDA Advisory Evaluation and Research, Food and UCM352467.pdf). Committee Information Line, 1–800– Drug Administration, 10903 New 4. U.S. Food and Drug Administration, 741–8138 (301–443–0572 in the Hampshire Ave., Bldg. 31, Rm. 2417, ‘‘Analytical Results from Inorganic Arsenic Washington, DC area). Please call the Silver Spring, MD 20993–0002, 301– in Rice Cereals for Infants, Non-rice Infant Cereal and Other Foods Commonly Eaten by Information Line for up-to-date 796–9001, email: BRUDAC@fda.hhs.gov. Infants and Toddlers,’’ 2016, (http:// information on this meeting. SUPPLEMENTARY INFORMATION: Pursuant www.fda.gov/Food/FoodScienceResearch/ SUPPLEMENTARY INFORMATION: In the to 41 CFR 102–3.65 and approval by the RiskSafetyAssessment/ucm485278.htm). Federal Register of March 17, 2016 (81 Department of Health and Human 5. U.S. Food and Drug Administration, FR 14448), FDA announced that a Services pursuant to 45 CFR part 11 and ‘‘Arsenic in Rice and Rice Products Risk meeting of the Endocrinologic and by the General Services Administration, Assessment: Report,’’ 2016, (http:// Metabolic Drugs Advisory Committee FDA is announcing the renewal of the www.fda.gov/Food/FoodScienceResearch/ would be held on May 25, 2016. On Bone, Reproductive and Urologic Drugs RiskSafetyAssessment/ucm485278.htm). 6. U.S. Food and Drug Administration, page 14449, in the first column, the Date Advisory Committee. The committee is ‘‘External Peer Review Report. Arsenic in and Time portion of the document is a discretionary Federal advisory Rice and Rice Products Risk Assessment: changed to read as follows: committee established to provide advice Draft Report, Addendum, and Model,’’ 2015, Date and Time: The meeting will be to the Commissioner. The Bone, (http://www.fda.gov/downloads/Food/ held on May 24, 2016, from 8 a.m. to 5 Reproductive and Urologic Drugs FoodScienceResearch/RiskSafetyAssessment/ p.m. Advisory Committee advises the UCM486544.pdf). This notice is issued under the Commissioner or designee in 7. U.S. Food and Drug Administration, Federal Advisory Committee Act (5 discharging responsibilities as they ‘‘FDA’s Response to External Peer Review on U.S.C. app. 2) and 21 CFR part 14, FDA’s Arsenic in Rice and Rice Products relate to helping to ensure safe and relating to the advisory committees. effective drugs for human use and, as Risk Assessment: Draft Report (July 2015), Addendum to FDA’s Arsenic in Rice and Dated: April 1, 2016. required, any other product for which Rice Products Risk Assessment, and Arsenic Jill Hartzler Warner, the Food and Drug Administration has in Rice and Rice Products Risk Assessment Associate Commissioner for Special Medical regulatory responsibility. The Cancer Model,’’ 2016, (http://www.fda.gov/ Programs. Committee reviews and evaluates data downloads/Food/FoodScienceResearch/ on the safety and effectiveness of [FR Doc. 2016–07906 Filed 4–5–16; 8:45 am] RiskSafetyAssessment/UCM487230.pdf). marketed and investigational human BILLING CODE 4164–01–P Dated: April 1, 2016. drug products for use in the practice of Leslie Kux, osteoporosis and metabolic bone Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND disease, obstetrics, gynecology, urology [FR Doc. 2016–07840 Filed 4–5–16; 8:45 am] HUMAN SERVICES and related specialties, and makes BILLING CODE 4164–01–P appropriate recommendations to the Food and Drug Administration Commissioner of Food and Drugs. The Committee shall consist of a core [Docket No. FDA–2016–N–0001] DEPARTMENT OF HEALTH AND of 11 voting members including the HUMAN SERVICES Advisory Committee; Bone, Chair. Members and the Chair are Reproductive and Urologic Drugs selected by the Commissioner or Food and Drug Administration Advisory Committee, Renewal designee from among authorities knowledgeable in the fields of [Docket No. FDA–2016–N–0001] AGENCY: Food and Drug Administration, osteoporosis and metabolic bone Endocrinologic and Metabolic Drugs HHS. disease, obstetrics, gynecology, urology, Advisory Committee; Amendment of ACTION:Notice; renewal of advisory pediatrics, epidemiology, or statistics Notice committee. and related specialties. Members will be invited to serve for overlapping terms of AGENCY: Food and Drug Administration, SUMMARY: The Food and Drug up to 4 years. Almost all non-Federal HHS. Administration (FDA) is announcing the members of this committee serve as ACTION: Notice. renewal of the Bone, Reproductive and Special Government Employees. The Urologic Drugs Advisory Committee by core of voting members may include one SUMMARY: The Food and Drug the Commissioner of Food and Drugs technically qualified member, selected Administration (FDA) is announcing an (the Commissioner). The Commissioner by the Commissioner or designee, who amendment to the notice of a meeting of has determined that it is in the public is identified with consumer interests the Endocrinologic and Metabolic Drugs interest to renew the Bone, and is recommended by either a Advisory Committee. This meeting was Reproductive and Urologic Drugs consortium of consumer-oriented announced in the Federal Register of Advisory Committee for an additional 2 organizations or other interested March 17, 2016. The amendment is years beyond the charter expiration persons. In addition to the voting being made to reflect a change in the date. The new charter will be in effect members, the Committee may include Date and Time portion of the document. until March 23, 2018. one non-voting member who is The Date of the meeting is changed to DATES: Authority for the Bone, identified with industry interests. May 24, 2016. There are no other Reproductive and Urologic Drugs Further information regarding the asabaliauskas on DSK3SPTVN1PROD with NOTICES changes. Advisory Committee will expire on most recent charter and other FOR FURTHER INFORMATION CONTACT: March 23, 2018, unless the information can be found at http:// LaToya Bonner, Center for Drug Commissioner formally determines that www.fda.gov/AdvisoryCommittees/ Evaluation and Research, Food and renewal is in the public interest. CommitteesMeetingMaterials/Drugs/ Drug Administration, 10903 New FOR FURTHER INFORMATION CONTACT: ReproductiveHealthDrugsAdvisory Hampshire Ave., Bldg.31, Rm. 2417, Kalyani Bhatt, Division of Advisory Committee/ucm107572.htm or by Silver Spring, MD 20993–0002, 301– Committee and Consultant contacting the Designated Federal 796–9001, FAX: 301–847–8533, Management, Center for Drug Officer (see FOR FURTHER INFORMATION VerDate Sep<11>2014 17:54 Apr 05, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\06APN1.SGM 06APN1

Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices 19979 CONTACT). In light of the fact that no compensation are to file a petition with condition set forth in the Vaccine Injury change has been made to the committee the U.S. Court of Federal Claims and to Table the first symptom or manifestation of name or description of duties, no serve a copy of the petition on the the onset or significant aggravation of which amendment will be made to 21 CFR Secretary of Health and Human did not occur within the time period set forth in the Table but which was caused by a 14.100. Services, who is named as the vaccine’’ referred to in the Table. This document is issued under the respondent in each proceeding. The Federal Advisory Committee Act (5 Secretary has delegated this In accordance with Section 2112(b)(2), U.S.C. app.). For general information responsibility under the Program to all interested persons may submit related to FDA advisory committees, HRSA. The Court is directed by statute written information relevant to the please visit us at http://www.fda.gov/ to appoint special masters who take issues described above in the case of the AdvisoryCommittees/default.htm. evidence, conduct hearings as petitions listed below. Any person Dated: April 1, 2016. appropriate, and make initial decisions choosing to do so should file an original Jill Hartzler Warner, as to eligibility for, and amount of, and three (3) copies of the information Associate Commissioner for Special Medical compensation. with the Clerk of the U.S. Court of Programs. A petition may be filed with respect Federal Claims at the address listed to injuries, disabilities, illnesses, above (under the heading ‘‘FOR FURTHER [FR Doc. 2016–07908 Filed 4–5–16; 8:45 am] conditions, and deaths resulting from INFORMATION CONTACT’’), with a copy to BILLING CODE 4164–01–P vaccines described in the Vaccine Injury HRSA addressed to Director, Division of Table (the Table) set forth at 42 CFR Injury Compensation Programs, DEPARTMENT OF HEALTH AND 100.3. This Table lists for each covered Healthcare Systems Bureau, 5600 HUMAN SERVICES childhood vaccine the conditions that Fishers Lane, 08N146B, Rockville, MD may lead to compensation and, for each 20857. The Court’s caption (Petitioner’s Health Resources and Services condition, the time period for Name v. Secretary of Health and Human Administration occurrence of the first symptom or Services) and the docket number manifestation of onset or of significant assigned to the petition should be used National Vaccine Injury Compensation aggravation after vaccine as the caption for the written Program; List of Petitions Received administration. Compensation may also submission. Chapter 35 of title 44, be awarded for conditions not listed in United States Code, related to AGENCY: Health Resources and Services the Table and for conditions that are paperwork reduction, does not apply to Administration, HHS. manifested outside the time periods information required for purposes of ACTION: Notice. specified in the Table, but only if the carrying out the Program. SUMMARY: The Health Resources and petitioner shows that the condition was Dated: March 28, 2016. Services Administration (HRSA) is caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 James Macrae, publishing this notice of petitions Acting Administrator. received under the National Vaccine U.S.C. 300aa–12(b)(2), requires that Injury Compensation Program (the ‘‘[w]ithin 30 days after the Secretary List of Petitions Filed Program), as required by Section receives service of any petition filed under section 2111 the Secretary shall 1. Tessa Skrypek on behalf of D. S., 2112(b)(2) of the Public Health Service Chippewa Falls, Wisconsin, Court (PHS) Act, as amended. While the publish notice of such petition in the Federal Register.’’ Set forth below is a of Federal Claims No: 16–0146V Secretary of Health and Human Services list of petitions received by HRSA on 2. Brandie Sanders, Cypress, Texas, is named as the respondent in all February 1, 2016, through February 29, Court of Federal Claims No: 16– proceedings brought by the filing of 2016. This list provides the name of 0147V petitions for compensation under the Program, the United States Court of petitioner, city and state of vaccination 3. Taylor K. Frady on behalf of A. F., Federal Claims is charged by statute (if unknown then city and state of Deceased, Piermont, New York, with responsibility for considering and person or attorney filing claim), and Court of Federal Claims No: 16– acting upon the petitions. case number. In cases where the Court 0148V FOR FURTHER INFORMATION CONTACT: For has redacted the name of a petitioner 4. Robert Kern, Lower Gwynedd, information about requirements for and/or the case number, the list reflects Pennsylvania, Court of Federal filing petitions, and the Program in such redaction. Claims No: 16–0150V Section 2112(b)(2) also provides that 5. Katherine R. Hime, South Bend, general, contact the Clerk, United States the special master ‘‘shall afford all Indiana, Court of Federal Claims Court of Federal Claims, 717 Madison interested persons an opportunity to No: 16–0151V Place NW., Washington, DC 20005, submit relevant, written information’’ 6. Emma Hicks, Madison, Wisconsin, (202) 357–6400. For information on relating to the following: Court of Federal Claims No: 16– HRSA’s role in the Program, contact the Director, National Vaccine Injury 1. The existence of evidence ‘‘that there is 0153V Compensation Program, 5600 Fishers not a preponderance of the evidence that the 7. Christina Garber, Honolulu, Hawaii, illness, disability, injury, condition, or death Court of Federal Claims No: 16– Lane, Room 08N146B, Rockville, MD described in the petition is due to factors 20857; (301) 443–6593, or visit our Web 0154V unrelated to the administration of the vaccine site at: http://www.hrsa.gov/ 8. Joseph T. Renfroe, Hiram, Georgia, asabaliauskas on DSK3SPTVN1PROD with NOTICES described in the petition,’’ and vaccinecompensation/index.html. 2. Any allegation in a petition that the Court of Federal Claims No: 16– SUPPLEMENTARY INFORMATION: The petitioner either: 0156V Program provides a system of no-fault a. ‘‘[S]ustained, or had significantly 9. Hannah Mackie, Chicago, Illinois, compensation for certain individuals aggravated, any illness, disability, injury, or Court of Federal Claims No: 16– condition not set forth in the Vaccine Injury who have been injured by specified 0157V Table but which was caused by’’ one of the childhood vaccines. Subtitle 2 of Title vaccines referred to in the Table, or 10. Laura McClary, Sacramento, XXI of the PHS Act, 42 U.S.C. 300aa– b. ‘‘[S]ustained, or had significantly California, Court of Federal Claims 10 et seq., provides that those seeking aggravated, any illness, disability, injury, or No: 16–0158V VerDate Sep<11>2014 17:54 Apr 05, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\06APN1.SGM 06APN1


Document Created: 2018-02-07 13:51:49
Document Modified: 2018-02-07 13:51:49
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; renewal of advisory committee.
DatesAuthority for the Bone, Reproductive and Urologic Drugs Advisory Committee will expire on March 23, 2018, unless the Commissioner formally determines that renewal is in the public interest.
ContactKalyani Bhatt, Division of Advisory Committee and Consultant Management, 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, email: [email protected]
FR Citation81 FR 19978 
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