80 FR 28621 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 96 (May 19, 2015)

Page Range		28621-28621
FR Document		2015-12078

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.

Federal Register, Volume 80 Issue 96 (Tuesday, May 19, 2015)

[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Page 28621]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12078]



[[Page 28621]]

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

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.

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

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, [email protected].

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 http://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

Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices 28621

DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND 301–796–3515, Georgiann.Ienzi@
HUMAN SERVICES HUMAN SERVICES fda.hhs.gov.
Registration: If you wish to attend the
Food and Drug Administration Food and Drug Administration public meeting or provide testimony
during the open public hearing, please
[Docket No. FDA–2011–N–0802]
[Docket No. FDA–2014–N–0998] email your registration to
Exploring Naloxone Uptake and Use; NaloxoneWorkshop@fda.hhs.gov by
Agency Information Collection Public Meeting; Request for Comments June 22, 2015. Those without email
Activities; Announcement of Office of access may register by contacting one of
AGENCY: Food and Drug Administration, the contact persons (see Contact
Management and Budget Approval; HHS.
Regulations for In Vivo Persons). When registering, please
ACTION: Notice of public meeting; provide complete contact information
Radiopharmaceuticals Used for
request for comments. for each attendee, including name, title,
Diagnosis and Monitoring
affiliation, address, email address, and
The Food and Drug Administration telephone number. Registration is free
AGENCY: Food and Drug Administration, (FDA), Center for Drug Evaluation and and will be on a first-come, first-served
HHS. Research, in collaboration with the basis. Early registration is recommended
ACTION: Notice. National Institutes on Drug Abuse, the because seating is limited. Registrants
Centers for Disease Control and will receive confirmation once they
Prevention, the Substance Abuse and have been accepted for the public
SUMMARY: The Food and Drug
Mental Health Services Administration, meeting. Onsite registration on the day
Administration (FDA) is announcing and the Health Resources and Services
that a collection of information entitled, of the public meeting will be permitted
Administration, will hold a public based on space availability. If
‘‘Regulations for In Vivo meeting to discuss increasing the use of
Radiopharmaceuticals Used for registration reaches maximum capacity,
naloxone to reduce the incidence of FDA will post a notice closing
Diagnosis and Monitoring’’ has been opioid drug overdose fatalities. During registration for the public meeting at:
approved by the Office of Management the meeting, academic and government http://www.fda.gov/Drugs/NewsEvents/
and Budget (OMB) under the Paperwork experts, industry representatives, and ucm442236.htm.
Reduction Act of 1995. patient advocates will discuss which Comments: Submit either electronic
FOR FURTHER INFORMATION CONTACT: FDA populations are at-risk for opioid drug or written comments by September 1,
PRA Staff, Office of Operations, Food overdose and how we can work together 2015. Submit electronic comments to
and Drug Administration, 8455 to encourage the use of naloxone to http://www.regulations.gov. Submit
reduce the risk of overdose from opioid written comments to the Division of
Colesville Rd., COLE–14526, Silver
drugs. Dockets Management (HFA 305), Food
Spring, MD 20993–0002, PRAStaff@ Date and Time: The public meeting and Drug Administration, 5630 Fishers
fda.hhs.gov. will be held on July 1, 2015, from 8 a.m. Lane, Rm. 1061, Rockville, MD 20852. It
SUPPLEMENTARY INFORMATION: On to 5 p.m. and on July 2, 2015, from 8 is only necessary to send one set of
January 08, 2015, the Agency submitted a.m. to 3 p.m. The open public hearing comments. Identify comments with the
a proposed collection of information will be held between 1 p.m. and 2 p.m. docket number found in brackets in the
on July 1, 2015, and between 1 p.m. and heading of this document. Received
entitled, ‘‘Regulations for In Vivo
2 p.m. on July 2, 2015, during which comments may be seen in the Division
Radiopharmaceuticals Used for
speaker testimony will be accepted. We of Dockets Management between 9 a.m.
Diagnosis and Monitoring’’ to OMB for will try to accommodate all persons and 4 p.m., Monday through Friday, and
review and clearance under 44 U.S.C. who wish to testify; however, the will be posted to the docket at http://
3507. An Agency may not conduct or duration of each speaker’s testimony www.regulations.gov. If you need
sponsor, and a person is not required to may be limited by time constraints. special accommodations due to a
respond to, a collection of information Those wishing to participate in the open disability, contact Mary Gross or
unless it displays a currently valid OMB public hearing should limit their Georgiann Ienzi (see Contact Persons) at
control number. OMB has now remarks to issues related to the uptake least 7 days in advance of the meeting.
approved the information collection and of naloxone both in conventional SUPPLEMENTARY INFORMATION:
has assigned OMB control number medical settings and outside of those
0910–0409. The approval expires on settings to reduce the incidence of I. Introduction
April 30, 2018. A copy of the supporting opioid drug overdose fatalities. The number of prescriptions filled for
statement for this information collection Location: The public meeting will be opioid drugs has increased drastically in
is available on the Internet at http:// held at the FDA White Oak Campus, recent years. In 2009 nearly 257 million
www.reginfo.gov/public/do/PRAMain. 10903 New Hampshire Ave., Building prescriptions were written for opioid
31 Conference Center, the Great Room drugs in the United States. This number
Dated: May 13, 2015.
(Rm. 1503), Silver Spring, MD 20993– rose to nearly 260 million in 2012. The
Leslie Kux, 0002. increased availability of opioid drugs
Associate Commissioner for Policy. Contact Person: Mary Gross, Center appears to be contributing significantly
[FR Doc. 2015–12078 Filed 5–18–15; 8:45 am] for Drug Evaluation and Research, Food to abuse and overdose in the United
BILLING CODE 4164–01–P and Drug Administration, 10903 New States. In 2013 there were
tkelley on DSK3SPTVN1PROD with NOTICES

Hampshire Ave., Silver Spring, MD approximately 16,235 deaths from
20993–0002, 301–796–3519, overdose involving opioid drugs. That
Mary.Gross@fda.hhs.gov; or Georgiann same year, there were 8,257 deaths from
Ienzi, Center for Drug Evaluation and overdose involving heroin.
Research, Food and Drug Naloxone, a mu-opioid antagonist, is
Administration, 10903 New Hampshire a medication that can rapidly reverse
Ave., Silver Spring, MD 20993–0002, the overdose of both prescription opioid

VerDate Sep<11>2014 16:53 May 18, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1

Document Created: 2015-12-15 15:29:34
Document Modified: 2015-12-15 15:29:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 28621

80 FR 28621 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 96 (May 19, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration