Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 51635 [2017-24189]
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51635
Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices
TABLE 1—CLASS II DEVICES—Continued
Product
code
21 CFR section
Device type
866.5950 ...............
Genetic Health Risk Assessment System ....................
PTA
876.1500 ...............
880.6710 ...............
884.5960 ...............
Endoscopic Maintenance System .................................
Purifier, Water, Ultraviolet, Medical ...............................
Vibrator for Therapeutic Use, Genital ...........................
Partial exemption limitation
(if applicable)
PUP
KMG
KXQ
Exemption is limited to a genetic health risk assessment system that has received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the
genetic health risk assessment system (a ‘‘one-time
FDA reviewed genetic health risk assessment system’’).
V. Reference
The following reference is on display
in the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is also available electronically at https://
www.regulations.gov. FDA has verified
the Web site address, as of the date this
document publishes in the Federal
Register, but Web sites are subject to
change over time.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1. FDA Guidance, ‘‘Procedures for Class II
Device Exemptions from Premarket
Notification, Guidance for Industry and
CDRH Staff,’’ February 19, 1998,
available at https://www.fda.gov/
downloads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM080199.pdf.
AGENCY:
Dated: October 31, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017–24163 Filed 11–6–17; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket Nos. FDA–2013–N–0618; FDA–
2013–N–1155; FDA–2010–N–0118; FDA–
2011–N–0655; FDA–2014–N–0086; FDA–
2011–N–0144; FDA–2016–N–2836]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
Food and Drug Administration,
HHS.
ACTION:
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, Office of Operations, Food
and Drug Administration, Three White
SUMMARY:
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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
Reporting and Recordkeeping for Electronic Products—General Requirements ...................................................
Food Labeling Regulations ......................................................................................................................................
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 ...........................................................................................................................................................
Animal Generic Drug User Fee Act Cover Sheet ...................................................................................................
Potential Tobacco Product Violations Reporting Form ...........................................................................................
Voluntary Qualified Importer Program Guidance for Industry .................................................................................
Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute—Sponsored
Transfusion-Transmissible Infectious Monitoring System ...................................................................................
ethrower on DSK3G9T082PROD with NOTICES
Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24189 Filed 11–6–17; 8:45 am]
BILLING CODE 4164–01–P
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Date approval
expires
0910–0025
0910–0381
7/31/2020
7/31/2020
0910–0520
0910–0632
0910–0716
0910–0840
7/31/2020
7/31/2020
7/31/2020
7/31/2020
0910–0841
7/31/2020
]]>Agencies
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Page 51635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24189]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0618; FDA-2013-N-1155; FDA-2010-N-0118; FDA-
2011-N-0655; FDA-2014-N-0086; FDA-2011-N-0144; FDA-2016-N-2836]
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, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 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
------------------------------------------------------------------------
Reporting and Recordkeeping for 0910-0025 7/31/2020
Electronic Products--General
Requirements...........................
Food Labeling Regulations............... 0910-0381 7/31/2020
Prior Notice of Imported Food Under the 0910-0520 7/31/2020
Public Health Security and Bioterrorism
Preparedness and Response Act of 2002..
Animal Generic Drug User Fee Act Cover 0910-0632 7/31/2020
Sheet..................................
Potential Tobacco Product Violations 0910-0716 7/31/2020
Reporting Form.........................
Voluntary Qualified Importer Program 0910-0840 7/31/2020
Guidance for Industry..................
Donor Risk Assessment Questionnaire for 0910-0841 7/31/2020
the FDA/National Heart, Lung, and Blood
Institute--Sponsored Transfusion-
Transmissible Infectious Monitoring
System.................................
------------------------------------------------------------------------
Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24189 Filed 11-6-17; 8:45 am]
BILLING CODE 4164-01-P
