81 FR 62743 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 176 (September 12, 2016)

Page Range		62743-62743
FR Document		2016-21877

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 81 Issue 176 (Monday, September 12, 2016)

[Federal Register Volume 81, Number 176 (Monday, September 12, 2016)]
[Notices]
[Page 62743]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21877]



[[Page 62743]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-N-0628; FDA-2012-N-0306; FDA-2002-N-0323; FDA-
2012-N-0427; FDA-2012-N-0536; FDA-2012-N-0560; FDA-2015-N-3662; FDA-
2012-N-0976; FDA-2013-N-0297; FDA-2012-N-1203; FDA-2011-D-0893; FDA-
2014-N-0189; FDA-2012-N-1210]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
information collections that have 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, Three White Flint North, 11601 Landsdown 
St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information 
collections recently approved by OMB under section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control 
number and expiration date of OMB approval for each information 
collection are shown in table 1. Copies of the supporting statements 
for the information collections are available on the Internet at http://www.reginfo.gov/public/do/PRAMain. 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.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Reporting Associated with New Animal           0910-0032       8/31/2019
 Drug Applications......................
Administrative Detention and Banned            0910-0114       8/31/2019
 Medical Devices........................
Registration of Food Facilities.........       0910-0502       8/31/2019
Inspection by Accredited Persons Program       0910-0510       8/31/2019
 Under the Medical Device User Fee and
 Modernization Act of 2002..............
Medical Device User Fee Cover Sheet--FDA       0910-0511       8/31/2019
 Form 3601..............................
Guidance on Informed Consent for in            0910-0582       8/31/2019
 Vitro Diagnostic Studies Using Leftover
 Human Specimens That Are Not
 Individually Identifiable..............
Guidance for Reagents for Detection of         0910-0584       8/31/2019
 Specific Novel Influenza A Viruses.....
Guidance: Emergency Use Authorization of       0910-0595       8/31/2019
 Medical Products.......................
Prevention of Salmonella Enteritidis in        0910-0660       8/31/2019
 Shell Eggs During Production--
 Recordkeeping and Registration
 Provisions.............................
Information to Accompany Humanitarian          0910-0661       8/31/2019
 Device Exemption Applications and
 Annual Distribution Number Reporting
 Requirements...........................
Guidance for Center for Devices and            0910-0738       8/31/2019
 Radiological Health Appeals Processes..
Deeming Tobacco Products To Be Subject         0910-0768       8/31/2019
 to the FD&C Act........................
Food Labeling: Revision of the Nutrition       0910-0813       7/31/2019
 Facts Label and Supplement Facts Label.
------------------------------------------------------------------------


    Dated: September 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21877 Filed 9-9-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 176 / Monday, September 12, 2016 / Notices 62743

DEPARTMENT OF HEALTH AND ACTION: Notice. under section 3507 of the Paperwork
HUMAN SERVICES Reduction Act of 1995 (44 U.S.C. 3507).
SUMMARY: The Food and Drug The OMB control number and
Food and Drug Administration Administration (FDA) is publishing a expiration date of OMB approval for
list of information collections that have each information collection are shown
[Docket Nos. FDA–2016–N–0628; been approved by the Office of
FDA–2012–N–0306; FDA–2002–N–0323; in table 1. Copies of the supporting
Management and Budget (OMB) under
FDA–2012–N–0427; FDA–2012–N–0536; statements for the information
the Paperwork Reduction Act of 1995.
FDA–2012–N–0560; FDA–2015–N–3662; collections are available on the Internet
FDA–2012–N–0976; FDA–2013–N–0297; FOR FURTHER INFORMATION CONTACT: FDA at http://www.reginfo.gov/public/do/
FDA–2012–N–1203; FDA–2011–D–0893; PRA Staff, Office of Operations, Food PRAMain. An Agency may not conduct
FDA–2014–N–0189; FDA–2012–N–1210] and Drug Administration, Three White or sponsor, and a person is not required
Flint North, 11601 Landsdown St., to respond to, a collection of
Agency Information Collection North Bethesda, MD 20852, PRAStaff@
Activities; Announcement of Office of information unless it displays a
fda.hhs.gov.
Management and Budget Approvals currently valid OMB control number.
SUPPLEMENTARY INFORMATION: The
AGENCY: Food and Drug Administration, following is a list of FDA information
HHS. collections recently approved by OMB

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
OMB control
Title of collection approval
No. expires

Reporting Associated with New Animal Drug Applications ..................................................................................... 0910–0032 8/31/2019
Administrative Detention and Banned Medical Devices ......................................................................................... 0910–0114 8/31/2019
Registration of Food Facilities ................................................................................................................................. 0910–0502 8/31/2019
Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of
2002 ..................................................................................................................................................................... 0910–0510 8/31/2019
Medical Device User Fee Cover Sheet—FDA Form 3601 ..................................................................................... 0910–0511 8/31/2019
Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens That Are Not
Individually Identifiable ......................................................................................................................................... 0910–0582 8/31/2019
Guidance for Reagents for Detection of Specific Novel Influenza A Viruses ......................................................... 0910–0584 8/31/2019
Guidance: Emergency Use Authorization of Medical Products .............................................................................. 0910–0595 8/31/2019
Prevention of Salmonella Enteritidis in Shell Eggs During Production—Recordkeeping and Registration Provi-
sions ..................................................................................................................................................................... 0910–0660 8/31/2019
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Re-
porting Requirements ........................................................................................................................................... 0910–0661 8/31/2019
Guidance for Center for Devices and Radiological Health Appeals Processes ..................................................... 0910–0738 8/31/2019
Deeming Tobacco Products To Be Subject to the FD&C Act ................................................................................ 0910–0768 8/31/2019
Food Labeling: Revision of the Nutrition Facts Label and Supplement Facts Label ............................................. 0910–0813 7/31/2019

Dated: September 6, 2016. Advisory Committee, Office of Science, Ave., Bldg. 32, Rm. 5103, Silver Spring,
Leslie Kux, Center for Tobacco Products. MD 20993–0002.
Associate Commissioner for Policy. FDA seeks to include the views of FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2016–21877 Filed 9–9–16; 8:45 am] women and men, members of all racial Regarding all nomination questions for
BILLING CODE 4164–01–P and ethnic groups, and individuals with membership, the primary contact is:
and without disabilities on its advisory Caryn Cohen, Office of Science, Center
committees and, therefore, encourages for Tobacco Products, Food and Drug
DEPARTMENT OF HEALTH AND nominations of appropriately qualified Administration, Document Control
HUMAN SERVICES candidates from these groups. Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
Food and Drug Administration DATES: Nominations received on or 20993–0002, 1–877–287–1373 (choose
before November 14, 2016 will be given Option 5), TPSAC@fda.hhs.gov.
first consideration for membership on Information about becoming a
[Docket No. FDA–2016–N–0001]
the Tobacco Products Scientific member on an FDA advisory committee
Request for Nominations for Voting Advisory Committee. Nominations can also be obtained by visiting FDA’s
Members on a Public Advisory received after November 14, 2016 will Web site by using the following link:
Committee; Tobacco Products be considered for nomination to the http://www.fda.gov/
Scientific Advisory Committee committee as later vacancies occur. AdvisoryCommittees/default.htm.
ADDRESSES: All nominations for SUPPLEMENTARY INFORMATION: FDA is
AGENCY: Food and Drug Administration, membership should be sent
sradovich on DSK3GMQ082PROD with NOTICES

requesting nominations for voting
HHS. electronically by logging into the FDA members on the Tobacco Products
ACTION: Notice. Advisory Nomination Portal: http:// Scientific Advisory Committee.
www.accessdata.fda.gov/scripts/
SUMMARY: The Food and Drug FACTRSPortal/FACTRS/index.cfm or by I. General Description of the Committee
Administration (FDA) is requesting mail to Advisory Committee Oversight Duties
nominations for voting members to and Management Staff, Food and Drug The Tobacco Products Scientific
serve on the Tobacco Products Scientific Administration, 10903 New Hampshire Advisory Committee (the Committee)

VerDate Sep<11>2014 18:40 Sep 09, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1

Document Created: 2016-09-10 00:57:09
Document Modified: 2016-09-10 00:57:09

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, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		81 FR 62743

81 FR 62743 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 176 (September 12, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration