Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 90363 [2016-30035]
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Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices
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the transcript will also be available on
the Internet at https://www.fda.gov/
ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm527587.htm.
90363
Dated: December 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
[FR Doc. 2016–29998 Filed 12–13–16; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0375; FDA–
2013–N–0370; FDA–2013–N–0134; FDA–
2009–N–0511; FDA–1997–N–0020; FDA–
2011–N–0902; FDA–2013–N–0662; FDA–
2013–N–0450; FDA–2012–N–0477; FDA–
2013–N–0519]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
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 https://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.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Agreement for Shipments of Devices for Sterilization ............................................................................................
Export of Medical Devices—Foreign Letters of Approval .......................................................................................
Mammography Facilities, Standards, and Lay Summaries for Patients .................................................................
Medicated Fee Mill License Application ..................................................................................................................
Substances Generally Recognized as Safe: Notification Procedure ......................................................................
Prescription Drug Product Labeling; Medication Guide Requirements ...................................................................
Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug is Invalid or Will Not be Infringed ......................................................................................................
Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed ..........
Investigational Device Exemptions Reports and Records—21 CFR 812 ...............................................................
Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine
Using the FDA Electronic Submission Gateway .................................................................................................
Dated: December 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30035 Filed 12–13–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2016–N–4119]
Food Safety Modernization Act ThirdParty Certification Program User Fee
Rate for Fiscal Year 2017
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:45 Dec 13, 2016
Jkt 241001
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2017 fee rate for
accreditation bodies applying to be
recognized in the third-party
certification program that is authorized
by the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the FDA Food Safety
Modernization Act (FSMA).
FOR FURTHER INFORMATION CONTACT:
Sylvia Kim, Office of Foods and
Veterinary Medicine, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3212, Silver Spring,
MD 20993, 301–796–7599.
DATES: This fee is effective January 13,
2017, and will remain in effect through
September 30, 2017.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Date
approval
expires
0910–0131
0910–0264
0910–0309
0910–0337
0910–0342
0910–0393
9/30/2019
9/30/2019
9/30/2019
9/30/2019
9/30/2019
9/30/2019
0910–0513
0910–0339
0910–0078
9/30/2016
10/31/2019
11/30/2019
0910–0454
11/30/2019
I. Background
Section 307 of FSMA, Accreditation
of Third-Party Auditors, amends the
FD&C Act to create a new provision,
section 808, under the same name.
Section 808 of the FD&C Act (21 U.S.C.
384d) directs us to establish a new
program for accreditation of third-party
certification bodies 1 conducting food
safety audits and issuing food and
facility certifications to eligible foreign
entities (including registered foreign
1 For the reasons explained in the third-party
certification final rule (80 FR74570 at 74578–74579,
November 27, 2015), and for consistency with the
implementing regulations for the third-party
certification program in 21 CFR parts 1, 11, and 16,
this notice uses the term ‘‘third-party certification
body’’ rather than the term ‘‘third-party auditor’’
used in section 808(a)(3) of the FD&C Act.
E:\FR\FM\14DEN1.SGM
14DEN1
]]>Agencies
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Notices]
[Page 90363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30035]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0375; FDA-2013-N-0370; FDA-2013-N-0134; FDA-
2009-N-0511; FDA-1997-N-0020; FDA-2011-N-0902; FDA-2013-N-0662; FDA-
2013-N-0450; FDA-2012-N-0477; FDA-2013-N-0519]
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, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
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 https://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
------------------------------------------------------------------------
Agreement for Shipments of Devices for 0910-0131 9/30/2019
Sterilization..........................
Export of Medical Devices--Foreign 0910-0264 9/30/2019
Letters of Approval....................
Mammography Facilities, Standards, and 0910-0309 9/30/2019
Lay Summaries for Patients.............
Medicated Fee Mill License Application.. 0910-0337 9/30/2019
Substances Generally Recognized as Safe: 0910-0342 9/30/2019
Notification Procedure.................
Prescription Drug Product Labeling; 0910-0393 9/30/2019
Medication Guide Requirements..........
Applications for FDA Approval to Market 0910-0513 9/30/2016
a New Drug: Patent Submission and
Listing Requirements and Application of
30-month Stays on Approval of
Abbreviated New Drug Applications
Certifying That a Patent Claiming a
Drug is Invalid or Will Not be
Infringed..............................
Substances Prohibited from Use in Animal 0910-0339 10/31/2019
Food or Feed; Animal Proteins
Prohibited in Ruminant Feed............
Investigational Device Exemptions 0910-0078 11/30/2019
Reports and Records--21 CFR 812........
Guidance for Industry on How to Submit 0910-0454 11/30/2019
Information in Electronic Format to the
Center for Veterinary Medicine Using
the FDA Electronic Submission Gateway..
------------------------------------------------------------------------
Dated: December 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30035 Filed 12-13-16; 8:45 am]
BILLING CODE 4164-01-P
