Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 40009 [2017-17871]
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Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices
received no comments on the draft
guidance. The guidance announced in
this notice finalizes the draft guidance
dated June 2015.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on oncology drugs for
companion animals. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 514.1 and 514.8 have been
approved under OMB control number
0910–0032.
IV. Electronic Access
ACTION:
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
40009
SUMMARY:
Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17855 Filed 8–22–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0804; FDA–
2013–N–1163; FDA–2013–N–1393; FDA–
2017–N–0084; FDA–2013–N–0731; FDA–
2009–D–0008; FDA–2013–N–0868; FDA–
2013–D–0117; FDA–2016–N–2066; FDA–
2017–N–0366]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
Notice.
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: Ila
S. Mizrachi, FDA PRA Staff, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 11601 Landsdown St., North
Bethesda, MD 20852, 301–796–7726,
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
No.
Title of collection
Premarket Notification Submission 510(k), Subpart E ............................................................................................
Institutional Review Boards .....................................................................................................................................
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions ................................
Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)) .................................
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products .............
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act ........................................................................................................................................................
Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion .........................................................
Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food,
Drug, and Cosmetic Act .......................................................................................................................................
Certification of Identity for Freedom of Information Act and Privacy Act Requests ...............................................
FDA Advisory Committee Membership Nominations ..............................................................................................
Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17871 Filed 8–22–17; 8:45 am]
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Date approval
expires
0910–0120
0910–0130
0910–0233
0910–0471
0910–0543
6/30/2020
6/30/2020
6/30/2020
6/30/2020
6/30/2020
0910–0679
6/30/2020
0910–0681
6/30/2020
0910–0762
0910–0832
0910–0833
6/30/2020
6/30/2020
6/30/2020
]]>Agencies
[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Page 40009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17871]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0804; FDA-2013-N-1163; FDA-2013-N-1393; FDA-
2017-N-0084; FDA-2013-N-0731; FDA-2009-D-0008; FDA-2013-N-0868; FDA-
2013-D-0117; FDA-2016-N-2066; FDA-2017-N-0366]
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: Ila S. Mizrachi, FDA PRA Staff, Office
of Operations, Food and Drug Administration, Three White Flint North,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
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
------------------------------------------------------------------------
Premarket Notification Submission 0910-0120 6/30/2020
510(k), Subpart E......................
Institutional Review Boards............. 0910-0130 6/30/2020
Patent Term Restoration, Due Diligence 0910-0233 6/30/2020
Petitions, Filing, Format, and Content
of Petitions...........................
Adverse Event Program for Medical 0910-0471 6/30/2020
Devices (Medical Product Safety Network
(MedSun))..............................
Eligibility Determination for Donors of 0910-0543 6/30/2020
Human Cells, Tissues, and Cellular and
Tissue-Based Products..................
Citizen Petitions and Petitions for Stay 0910-0679 6/30/2020
of Action Subject to Section 505(q) of
the Federal Food, Drug, and Cosmetic
Act....................................
Guidance for Industry: Use of 0910-0681 6/30/2020
Serological Tests to Reduce the Risk of
Transmission of Trypanosoma cruzi
Infection in Whole Blood and Blood
Components Intended for Transfusion....
Providing Information About Pediatric 0910-0762 6/30/2020
Uses of Medical Devices Under Section
515A of the Federal Food, Drug, and
Cosmetic Act...........................
Certification of Identity for Freedom of 0910-0832 6/30/2020
Information Act and Privacy Act
Requests...............................
FDA Advisory Committee Membership 0910-0833 6/30/2020
Nominations............................
------------------------------------------------------------------------
Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17871 Filed 8-22-17; 8:45 am]
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