81 FR 90363 - 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 240 (December 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 240 (December 14, 2016)
| Page Range | 90363-90363 | |
| FR Document | 2016-30035 |
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)] [Notices] [Page 90363] From the Federal Register Online [www.thefederalregister.org] [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, [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 ------------------------------------------------------------------------ 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
![Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices 90363
Patients who are interested in Dated: December 9, 2016. been approved by the Office of
presenting comments as part of the Leslie Kux, Management and Budget (OMB) under
initial panel discussions will be asked Associate Commissioner for Policy. the Paperwork Reduction Act of 1995.
to indicate in their registration which [FR Doc. 2016–29998 Filed 12–13–16; 8:45 am]
topic(s) they wish to address. These FOR FURTHER INFORMATION CONTACT: FDA
BILLING CODE 4164–01–P
patients also must send to PRA Staff, Office of Operations, Food
PatientFocused@fda.hhs.gov a brief and Drug Administration, Three White
summary of responses to the topic DEPARTMENT OF HEALTH AND Flint North, 10A63, 11601 Landsdown
questions by March 20, 2017. Panelists HUMAN SERVICES St., North Bethesda, MD 20852,
will be notified of their selection PRAStaff@fda.hhs.gov.
approximately 7 days before the public Food and Drug Administration SUPPLEMENTARY INFORMATION: The
meeting. We will try to accommodate all [Docket Nos. FDA–2013–N–0375; FDA– following is a list of FDA information
patients and patient stakeholders who 2013–N–0370; FDA–2013–N–0134; FDA– collections recently approved by OMB
wish to speak, either through the panel 2009–N–0511; FDA–1997–N–0020; FDA– under section 3507 of the Paperwork
discussion or audience participation; 2011–N–0902; FDA–2013–N–0662; FDA–
Reduction Act of 1995 (44 U.S.C. 3507).
however, the duration of comments may 2013–N–0450; FDA–2012–N–0477; FDA–
be limited by time constraints. 2013–N–0519] The OMB control number and
Transcripts: Please be advised that as expiration date of OMB approval for
soon as a transcript of the public Agency Information Collection each information collection are shown
meeting is available, it will be accessible Activities; Announcement of Office of in table 1. Copies of the supporting
at https://www.regulations.gov. It may Management and Budget Approvals statements for the information
be viewed at the Division of Dockets AGENCY: Food and Drug Administration, collections are available on the Internet
Management (see ADDRESSES). A link to HHS. at http://www.reginfo.gov/public/do/
the transcript will also be available on PRAMain. An Agency may not conduct
ACTION: Notice.
the Internet at http://www.fda.gov/ or sponsor, and a person is not required
ForIndustry/UserFees/ SUMMARY: The Food and Drug to respond to, a collection of
PrescriptionDrugUserFee/ Administration (FDA) is publishing a information unless it displays a
ucm527587.htm. list of information collections that have currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
OMB
Title of collection approval
control No. expires
Agreement for Shipments of Devices for Sterilization ............................................................................................ 0910–0131 9/30/2019
Export of Medical Devices—Foreign Letters of Approval ....................................................................................... 0910–0264 9/30/2019
Mammography Facilities, Standards, and Lay Summaries for Patients ................................................................. 0910–0309 9/30/2019
Medicated Fee Mill License Application .................................................................................................................. 0910–0337 9/30/2019
Substances Generally Recognized as Safe: Notification Procedure ...................................................................... 0910–0342 9/30/2019
Prescription Drug Product Labeling; Medication Guide Requirements ................................................................... 0910–0393 9/30/2019
Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Appli-
cation of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claim-
ing a Drug is Invalid or Will Not be Infringed ...................................................................................................... 0910–0513 9/30/2016
Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed .......... 0910–0339 10/31/2019
Investigational Device Exemptions Reports and Records—21 CFR 812 ............................................................... 0910–0078 11/30/2019
Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine
Using the FDA Electronic Submission Gateway ................................................................................................. 0910–0454 11/30/2019
Dated: December 9, 2016. SUMMARY: The Food and Drug I. Background
Leslie Kux, Administration (FDA) is announcing the
fiscal year (FY) 2017 fee rate for Section 307 of FSMA, Accreditation
Associate Commissioner for Policy.
accreditation bodies applying to be of Third-Party Auditors, amends the
[FR Doc. 2016–30035 Filed 12–13–16; 8:45 am]
recognized in the third-party FD&C Act to create a new provision,
BILLING CODE 4164–01–P
certification program that is authorized section 808, under the same name.
by the Federal Food, Drug, and Section 808 of the FD&C Act (21 U.S.C.
Cosmetic Act (the FD&C Act), as 384d) directs us to establish a new
DEPARTMENT OF HEALTH AND
amended by the FDA Food Safety program for accreditation of third-party
HUMAN SERVICES
Modernization Act (FSMA). certification bodies 1 conducting food
Food and Drug Administration safety audits and issuing food and
FOR FURTHER INFORMATION CONTACT:
facility certifications to eligible foreign
[Docket No. FDA–2016–N–4119] Sylvia Kim, Office of Foods and
entities (including registered foreign
Veterinary Medicine, Food and Drug
sradovich on DSK3GMQ082PROD with NOTICES
Food Safety Modernization Act Third- Administration, 10903 New Hampshire 1 For the reasons explained in the third-party
Party Certification Program User Fee Ave., Bldg. 1, Rm. 3212, Silver Spring, certification final rule (80 FR74570 at 74578–74579,
Rate for Fiscal Year 2017 MD 20993, 301–796–7599. November 27, 2015), and for consistency with the
DATES: This fee is effective January 13, implementing regulations for the third-party
AGENCY: Food and Drug Administration, certification program in 21 CFR parts 1, 11, and 16,
2017, and will remain in effect through
HHS. this notice uses the term ‘‘third-party certification
September 30, 2017. body’’ rather than the term ‘‘third-party auditor’’
ACTION: Notice.
SUPPLEMENTARY INFORMATION: used in section 808(a)(3) of the FD&C Act.
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Document Created: 2016-12-14 00:48:41
Document Modified: 2016-12-14 00:48:41
| 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, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 90363 |
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