Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring, 28621 [2015-12078]

Download as PDF Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2011–N–0802] [Docket No. FDA–2014–N–0998] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On January 08, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0409. The approval expires on April 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: May 13, 2015. Leslie Kux, Associate Commissioner for Policy. tkelley on DSK3SPTVN1PROD with NOTICES [FR Doc. 2015–12078 Filed 5–18–15; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:53 May 18, 2015 Jkt 235001 Exploring Naloxone Uptake and Use; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, in collaboration with the National Institutes on Drug Abuse, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Resources and Services Administration, will hold a public meeting to discuss increasing the use of naloxone to reduce the incidence of opioid drug overdose fatalities. During the meeting, academic and government experts, industry representatives, and patient advocates will discuss which populations are at-risk for opioid drug overdose and how we can work together to encourage the use of naloxone to reduce the risk of overdose from opioid drugs. Date and Time: The public meeting will be held on July 1, 2015, from 8 a.m. to 5 p.m. and on July 2, 2015, from 8 a.m. to 3 p.m. The open public hearing will be held between 1 p.m. and 2 p.m. on July 1, 2015, and between 1 p.m. and 2 p.m. on July 2, 2015, during which speaker testimony will be accepted. We will try to accommodate all persons who wish to testify; however, the duration of each speaker’s testimony may be limited by time constraints. Those wishing to participate in the open public hearing should limit their remarks to issues related to the uptake of naloxone both in conventional medical settings and outside of those settings to reduce the incidence of opioid drug overdose fatalities. Location: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. Contact Person: Mary Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3519, Mary.Gross@fda.hhs.gov; or Georgiann Ienzi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 28621 301–796–3515, Georgiann.Ienzi@ fda.hhs.gov. Registration: If you wish to attend the public meeting or provide testimony during the open public hearing, please email your registration to NaloxoneWorkshop@fda.hhs.gov by June 22, 2015. Those without email access may register by contacting one of the contact persons (see Contact Persons). When registering, please provide complete contact information for each attendee, including name, title, affiliation, address, email address, and telephone number. Registration is free and will be on a first-come, first-served basis. Early registration is recommended because seating is limited. Registrants will receive confirmation once they have been accepted for the public meeting. Onsite registration on the day of the public meeting will be permitted based on space availability. If registration reaches maximum capacity, FDA will post a notice closing registration for the public meeting at: https://www.fda.gov/Drugs/NewsEvents/ ucm442236.htm. Comments: Submit either electronic or written comments by September 1, 2015. 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. 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, and will be posted to the docket at https:// www.regulations.gov. If you need special accommodations due to a disability, contact Mary Gross or Georgiann Ienzi (see Contact Persons) at least 7 days in advance of the meeting. SUPPLEMENTARY INFORMATION: I. Introduction The number of prescriptions filled for opioid drugs has increased drastically in recent years. In 2009 nearly 257 million prescriptions were written for opioid drugs in the United States. This number rose to nearly 260 million in 2012. The increased availability of opioid drugs appears to be contributing significantly to abuse and overdose in the United States. In 2013 there were approximately 16,235 deaths from overdose involving opioid drugs. That same year, there were 8,257 deaths from overdose involving heroin. Naloxone, a mu-opioid antagonist, is a medication that can rapidly reverse the overdose of both prescription opioid E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Page 28621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12078]



[[Page 28621]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0998]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Regulations for In Vivo 
Radiopharmaceuticals Used for Diagnosis and Monitoring

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``Regulations for In Vivo 
Radiopharmaceuticals Used for Diagnosis and Monitoring'' has been 
approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On January 08, 2015, the Agency submitted a 
proposed collection of information entitled, ``Regulations for In Vivo 
Radiopharmaceuticals Used for Diagnosis and Monitoring'' to OMB for 
review and clearance under 44 U.S.C. 3507. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. 
OMB has now approved the information collection and has assigned OMB 
control number 0910-0409. The approval expires on April 30, 2018. A 
copy of the supporting statement for this information collection is 
available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: May 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12078 Filed 5-18-15; 8:45 am]
 BILLING CODE 4164-01-P
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