82 FR 51635 - 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 82, Issue 214 (November 7, 2017)

Page Range		51635-51635
FR Document		2017-24189

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.

Federal Register, Volume 82 Issue 214 (Tuesday, November 7, 2017)

[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Page 51635]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24189]


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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.

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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: 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, 
[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 
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

Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51635

TABLE 1—CLASS II DEVICES—Continued
Product Partial exemption limitation
21 CFR section Device type code (if applicable)

866.5950 ............... Genetic Health Risk Assessment System .................... PTA Exemption is limited to a genetic health risk assess-
ment system that has received a first-time FDA mar-
keting authorization (e.g., 510(k) clearance) for the
genetic health risk assessment system (a ‘‘one-time
FDA reviewed genetic health risk assessment sys-
tem’’).
876.1500 ............... Endoscopic Maintenance System ................................. PUP
880.6710 ............... Purifier, Water, Ultraviolet, Medical ............................... KMG
884.5960 ............... Vibrator for Therapeutic Use, Genital ........................... KXQ

V. Reference DEPARTMENT OF HEALTH AND Flint North, 10A–12M, 11601
The following reference is on display HUMAN SERVICES Landsdown St., North Bethesda, MD
in the Dockets Management Staff (see 20852, 301–796–7726, PRAStaff@
ADDRESSES) and is available for viewing
Food and Drug Administration fda.hhs.gov.
by interested persons between 9 a.m. [Docket Nos. FDA–2013–N–0618; FDA–
and 4 p.m., Monday through Friday; it 2013–N–1155; FDA–2010–N–0118; FDA– SUPPLEMENTARY INFORMATION: The
is also available electronically at https:// 2011–N–0655; FDA–2014–N–0086; FDA– following is a list of FDA information
www.regulations.gov. FDA has verified 2011–N–0144; FDA–2016–N–2836] collections recently approved by OMB
the Web site address, as of the date this under section 3507 of the Paperwork
document publishes in the Federal Agency Information Collection Reduction Act of 1995 (44 U.S.C. 3507).
Register, but Web sites are subject to Activities; Announcement of Office of The OMB control number and
change over time. Management and Budget Approvals expiration date of OMB approval for
1. FDA Guidance, ‘‘Procedures for Class II AGENCY: Food and Drug Administration, each information collection are shown
Device Exemptions from Premarket HHS. in table 1. Copies of the supporting
Notification, Guidance for Industry and ACTION: Notice. statements for the information
CDRH Staff,’’ February 19, 1998, collections are available on the internet
available at https://www.fda.gov/ SUMMARY: The Food and Drug at https://www.reginfo.gov/public/do/
downloads/MedicalDevices/ Administration (FDA) is publishing a PRAMain. An Agency may not conduct
DeviceRegulationandGuidance/ list of information collections that have
GuidanceDocuments/UCM080199.pdf. or sponsor, and a person is not required
been approved by the Office of to respond to, a collection of
Dated: October 31, 2017. Management and Budget (OMB) under information unless it displays a
Lauren Silvis, the Paperwork Reduction Act of 1995. currently valid OMB control number.
Chief of Staff. FOR FURTHER INFORMATION CONTACT: Ila
[FR Doc. 2017–24163 Filed 11–6–17; 8:45 am] S. Mizrachi, Office of Operations, Food
BILLING CODE 4164–01–P and Drug Administration, Three White

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires

Reporting and Recordkeeping for Electronic Products—General Requirements ................................................... 0910–0025 7/31/2020
Food Labeling Regulations ...................................................................................................................................... 0910–0381 7/31/2020
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 ........................................................................................................................................................... 0910–0520 7/31/2020
Animal Generic Drug User Fee Act Cover Sheet ................................................................................................... 0910–0632 7/31/2020
Potential Tobacco Product Violations Reporting Form ........................................................................................... 0910–0716 7/31/2020
Voluntary Qualified Importer Program Guidance for Industry ................................................................................. 0910–0840 7/31/2020
Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute—Sponsored
Transfusion-Transmissible Infectious Monitoring System ................................................................................... 0910–0841 7/31/2020

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]
ethrower on DSK3G9T082PROD with NOTICES

BILLING CODE 4164–01–P

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Document Created: 2018-10-25 10:27:04
Document Modified: 2018-10-25 10:27:04

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		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, [email protected]
FR Citation		82 FR 51635

82 FR 51635 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 214 (November 7, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration