Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 90363 [2016-30035]

Download as PDF Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices Patients who are interested in presenting comments as part of the initial panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients also must send to PatientFocused@fda.hhs.gov a brief summary of responses to the topic questions by March 20, 2017. Panelists will be notified of their selection approximately 7 days before the public meeting. We will try to accommodate all patients and patient stakeholders who wish to speak, either through the panel discussion or audience participation; however, the duration of comments may be limited by time constraints. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A link to the transcript will also be available on the Internet at http://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 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. 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]


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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.

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